EP3423559B1 - Non-enzymatic cleaner for reprocessing surgical instruments and flexible endoscopes - Google Patents
Non-enzymatic cleaner for reprocessing surgical instruments and flexible endoscopes Download PDFInfo
- Publication number
- EP3423559B1 EP3423559B1 EP16710931.3A EP16710931A EP3423559B1 EP 3423559 B1 EP3423559 B1 EP 3423559B1 EP 16710931 A EP16710931 A EP 16710931A EP 3423559 B1 EP3423559 B1 EP 3423559B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- weight
- cleaning
- compositions
- complexing agent
- composition
- Prior art date
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- 238000012958 reprocessing Methods 0.000 title description 2
- 239000000203 mixture Substances 0.000 claims description 405
- 238000004140 cleaning Methods 0.000 claims description 235
- 239000008139 complexing agent Substances 0.000 claims description 106
- 230000002255 enzymatic effect Effects 0.000 claims description 90
- 238000005260 corrosion Methods 0.000 claims description 83
- 235000014666 liquid concentrate Nutrition 0.000 claims description 71
- 239000002736 nonionic surfactant Substances 0.000 claims description 59
- 239000004094 surface-active agent Substances 0.000 claims description 58
- 239000006260 foam Substances 0.000 claims description 54
- 239000003795 chemical substances by application Substances 0.000 claims description 50
- 238000000034 method Methods 0.000 claims description 43
- -1 phosphate ester Chemical class 0.000 claims description 37
- 238000005187 foaming Methods 0.000 claims description 34
- 102000004190 Enzymes Human genes 0.000 claims description 27
- 108090000790 Enzymes Proteins 0.000 claims description 27
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims description 26
- 150000001412 amines Chemical class 0.000 claims description 23
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims description 18
- 229920001400 block copolymer Polymers 0.000 claims description 18
- 229910052751 metal Inorganic materials 0.000 claims description 16
- 239000002184 metal Substances 0.000 claims description 16
- 229920005682 EO-PO block copolymer Polymers 0.000 claims description 13
- 229910019142 PO4 Inorganic materials 0.000 claims description 11
- 239000003125 aqueous solvent Substances 0.000 claims description 10
- 239000010452 phosphate Substances 0.000 claims description 5
- 238000007865 diluting Methods 0.000 claims description 2
- UZVUJVFQFNHRSY-OUTKXMMCSA-J tetrasodium;(2s)-2-[bis(carboxylatomethyl)amino]pentanedioate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CC[C@@H](C([O-])=O)N(CC([O-])=O)CC([O-])=O UZVUJVFQFNHRSY-OUTKXMMCSA-J 0.000 claims description 2
- REELSMJRRUUNKR-UHFFFAOYSA-N 2-(methylamino)acetic acid;sodium Chemical compound [Na].CNCC(O)=O REELSMJRRUUNKR-UHFFFAOYSA-N 0.000 claims 1
- PDIZYYQQWUOPPK-UHFFFAOYSA-N acetic acid;2-(methylamino)acetic acid Chemical compound CC(O)=O.CC(O)=O.CNCC(O)=O PDIZYYQQWUOPPK-UHFFFAOYSA-N 0.000 claims 1
- 238000012360 testing method Methods 0.000 description 86
- 239000000243 solution Substances 0.000 description 84
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 61
- 238000009472 formulation Methods 0.000 description 53
- 229920001983 poloxamer Polymers 0.000 description 49
- 210000004369 blood Anatomy 0.000 description 47
- 239000008280 blood Substances 0.000 description 47
- 230000007797 corrosion Effects 0.000 description 41
- 239000003112 inhibitor Substances 0.000 description 30
- 239000002689 soil Substances 0.000 description 29
- 239000002253 acid Substances 0.000 description 26
- 239000000463 material Substances 0.000 description 23
- 239000003002 pH adjusting agent Substances 0.000 description 23
- CIEZZGWIJBXOTE-UHFFFAOYSA-N 2-[bis(carboxymethyl)amino]propanoic acid Chemical compound OC(=O)C(C)N(CC(O)=O)CC(O)=O CIEZZGWIJBXOTE-UHFFFAOYSA-N 0.000 description 21
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 21
- 239000003755 preservative agent Substances 0.000 description 21
- ABLZXFCXXLZCGV-UHFFFAOYSA-N Phosphorous acid Chemical class OP(O)=O ABLZXFCXXLZCGV-UHFFFAOYSA-N 0.000 description 18
- 239000011734 sodium Substances 0.000 description 18
- 230000002335 preservative effect Effects 0.000 description 17
- 239000008399 tap water Substances 0.000 description 16
- 235000020679 tap water Nutrition 0.000 description 16
- 239000007864 aqueous solution Substances 0.000 description 15
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 15
- 239000003752 hydrotrope Substances 0.000 description 15
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 14
- 239000007788 liquid Substances 0.000 description 14
- 150000003839 salts Chemical class 0.000 description 13
- 239000000126 substance Substances 0.000 description 12
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 description 11
- 239000000975 dye Substances 0.000 description 11
- 239000000047 product Substances 0.000 description 11
- QUCDWLYKDRVKMI-UHFFFAOYSA-M sodium;3,4-dimethylbenzenesulfonate Chemical compound [Na+].CC1=CC=C(S([O-])(=O)=O)C=C1C QUCDWLYKDRVKMI-UHFFFAOYSA-M 0.000 description 11
- 230000001965 increasing effect Effects 0.000 description 10
- 235000021317 phosphate Nutrition 0.000 description 10
- 238000002360 preparation method Methods 0.000 description 10
- 239000000523 sample Substances 0.000 description 10
- 239000002904 solvent Substances 0.000 description 10
- 239000012085 test solution Substances 0.000 description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 9
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 9
- 239000004698 Polyethylene Substances 0.000 description 9
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 9
- 229910052783 alkali metal Inorganic materials 0.000 description 9
- 229910052782 aluminium Inorganic materials 0.000 description 9
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 9
- 210000001124 body fluid Anatomy 0.000 description 9
- 239000010839 body fluid Substances 0.000 description 9
- 239000003093 cationic surfactant Substances 0.000 description 9
- 235000014113 dietary fatty acids Nutrition 0.000 description 9
- 239000000194 fatty acid Substances 0.000 description 9
- 229930195729 fatty acid Natural products 0.000 description 9
- 229920000573 polyethylene Polymers 0.000 description 9
- 230000008569 process Effects 0.000 description 9
- 229910052708 sodium Inorganic materials 0.000 description 9
- OHOTVSOGTVKXEL-UHFFFAOYSA-K trisodium;2-[bis(carboxylatomethyl)amino]propanoate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)C(C)N(CC([O-])=O)CC([O-])=O OHOTVSOGTVKXEL-UHFFFAOYSA-K 0.000 description 9
- 239000003945 anionic surfactant Substances 0.000 description 8
- 229920001577 copolymer Polymers 0.000 description 8
- 238000002474 experimental method Methods 0.000 description 8
- NAQMVNRVTILPCV-UHFFFAOYSA-N hexane-1,6-diamine Chemical compound NCCCCCCN NAQMVNRVTILPCV-UHFFFAOYSA-N 0.000 description 8
- 239000008213 purified water Substances 0.000 description 8
- 150000003384 small molecules Chemical class 0.000 description 8
- JBVOQKNLGSOPNZ-UHFFFAOYSA-N 2-propan-2-ylbenzenesulfonic acid Chemical class CC(C)C1=CC=CC=C1S(O)(=O)=O JBVOQKNLGSOPNZ-UHFFFAOYSA-N 0.000 description 7
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 description 7
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 7
- 229960002303 citric acid monohydrate Drugs 0.000 description 7
- 229910021645 metal ion Inorganic materials 0.000 description 7
- 150000007524 organic acids Chemical class 0.000 description 7
- 235000011121 sodium hydroxide Nutrition 0.000 description 7
- 159000000000 sodium salts Chemical class 0.000 description 7
- 230000004580 weight loss Effects 0.000 description 7
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 6
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 6
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 6
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 description 6
- 125000004432 carbon atom Chemical group C* 0.000 description 6
- 230000007935 neutral effect Effects 0.000 description 6
- 235000012736 patent blue V Nutrition 0.000 description 6
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 6
- 150000003014 phosphoric acid esters Chemical class 0.000 description 6
- 229910052700 potassium Inorganic materials 0.000 description 6
- 239000011591 potassium Substances 0.000 description 6
- 238000004659 sterilization and disinfection Methods 0.000 description 6
- RTMBGDBBDQKNNZ-UHFFFAOYSA-L C.I. Acid Blue 3 Chemical compound [Ca+2].C1=CC(N(CC)CC)=CC=C1C(C=1C(=CC(=C(O)C=1)S([O-])(=O)=O)S([O-])(=O)=O)=C1C=CC(=[N+](CC)CC)C=C1.C1=CC(N(CC)CC)=CC=C1C(C=1C(=CC(=C(O)C=1)S([O-])(=O)=O)S([O-])(=O)=O)=C1C=CC(=[N+](CC)CC)C=C1 RTMBGDBBDQKNNZ-UHFFFAOYSA-L 0.000 description 5
- KXDHJXZQYSOELW-UHFFFAOYSA-N Carbamic acid Chemical compound NC(O)=O KXDHJXZQYSOELW-UHFFFAOYSA-N 0.000 description 5
- 150000007513 acids Chemical class 0.000 description 5
- 125000000217 alkyl group Chemical group 0.000 description 5
- 239000002280 amphoteric surfactant Substances 0.000 description 5
- 150000001735 carboxylic acids Chemical class 0.000 description 5
- 229960004106 citric acid Drugs 0.000 description 5
- 235000008504 concentrate Nutrition 0.000 description 5
- 239000012141 concentrate Substances 0.000 description 5
- 239000003599 detergent Substances 0.000 description 5
- DUYCTCQXNHFCSJ-UHFFFAOYSA-N dtpmp Chemical compound OP(=O)(O)CN(CP(O)(O)=O)CCN(CP(O)(=O)O)CCN(CP(O)(O)=O)CP(O)(O)=O DUYCTCQXNHFCSJ-UHFFFAOYSA-N 0.000 description 5
- 239000003205 fragrance Substances 0.000 description 5
- 238000007654 immersion Methods 0.000 description 5
- 235000005985 organic acids Nutrition 0.000 description 5
- 239000004177 patent blue V Substances 0.000 description 5
- 230000002829 reductive effect Effects 0.000 description 5
- BPSYZMLXRKCSJY-UHFFFAOYSA-N 1,3,2-dioxaphosphepan-2-ium 2-oxide Chemical compound O=[P+]1OCCCCO1 BPSYZMLXRKCSJY-UHFFFAOYSA-N 0.000 description 4
- HZAXFHJVJLSVMW-UHFFFAOYSA-N 2-Aminoethan-1-ol Chemical compound NCCO HZAXFHJVJLSVMW-UHFFFAOYSA-N 0.000 description 4
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 4
- 229910000831 Steel Inorganic materials 0.000 description 4
- YAWYUSRBDMEKHZ-UHFFFAOYSA-N [2-hydroxyethyl(phosphonomethyl)amino]methylphosphonic acid Chemical compound OCCN(CP(O)(O)=O)CP(O)(O)=O YAWYUSRBDMEKHZ-UHFFFAOYSA-N 0.000 description 4
- 239000002535 acidifier Substances 0.000 description 4
- 150000008044 alkali metal hydroxides Chemical class 0.000 description 4
- 125000005907 alkyl ester group Chemical group 0.000 description 4
- 239000004411 aluminium Substances 0.000 description 4
- 150000003863 ammonium salts Chemical class 0.000 description 4
- 239000002518 antifoaming agent Substances 0.000 description 4
- DMSMPAJRVJJAGA-UHFFFAOYSA-N benzo[d]isothiazol-3-one Chemical compound C1=CC=C2C(=O)NSC2=C1 DMSMPAJRVJJAGA-UHFFFAOYSA-N 0.000 description 4
- MRNZSTMRDWRNNR-UHFFFAOYSA-N bis(hexamethylene)triamine Chemical compound NCCCCCCNCCCCCCN MRNZSTMRDWRNNR-UHFFFAOYSA-N 0.000 description 4
- 230000015556 catabolic process Effects 0.000 description 4
- 239000008367 deionised water Substances 0.000 description 4
- 230000001419 dependent effect Effects 0.000 description 4
- ZBCBWPMODOFKDW-UHFFFAOYSA-N diethanolamine Chemical compound OCCNCCO ZBCBWPMODOFKDW-UHFFFAOYSA-N 0.000 description 4
- 238000010790 dilution Methods 0.000 description 4
- 239000012895 dilution Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 150000004665 fatty acids Chemical class 0.000 description 4
- 235000013305 food Nutrition 0.000 description 4
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 239000002304 perfume Substances 0.000 description 4
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 4
- 229940079842 sodium cumenesulfonate Drugs 0.000 description 4
- QEKATQBVVAZOAY-UHFFFAOYSA-M sodium;4-propan-2-ylbenzenesulfonate Chemical compound [Na+].CC(C)C1=CC=C(S([O-])(=O)=O)C=C1 QEKATQBVVAZOAY-UHFFFAOYSA-M 0.000 description 4
- 239000010959 steel Substances 0.000 description 4
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 4
- 238000005406 washing Methods 0.000 description 4
- 125000000008 (C1-C10) alkyl group Chemical group 0.000 description 3
- LJKDOMVGKKPJBH-UHFFFAOYSA-L 2-ethylhexyl phosphate Chemical compound CCCCC(CC)COP([O-])([O-])=O LJKDOMVGKKPJBH-UHFFFAOYSA-L 0.000 description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 3
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 description 3
- WMFOQBRAJBCJND-UHFFFAOYSA-M Lithium hydroxide Chemical compound [Li+].[OH-] WMFOQBRAJBCJND-UHFFFAOYSA-M 0.000 description 3
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical class CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- 230000002378 acidificating effect Effects 0.000 description 3
- 230000009471 action Effects 0.000 description 3
- 150000003973 alkyl amines Chemical class 0.000 description 3
- 238000011109 contamination Methods 0.000 description 3
- 239000013078 crystal Substances 0.000 description 3
- 238000006731 degradation reaction Methods 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 239000000839 emulsion Substances 0.000 description 3
- 150000002148 esters Chemical class 0.000 description 3
- 150000002191 fatty alcohols Chemical class 0.000 description 3
- 229960002989 glutamic acid Drugs 0.000 description 3
- 235000013922 glutamic acid Nutrition 0.000 description 3
- 239000004220 glutamic acid Substances 0.000 description 3
- 229910052736 halogen Inorganic materials 0.000 description 3
- 150000002367 halogens Chemical class 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 150000002500 ions Chemical class 0.000 description 3
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- 150000007522 mineralic acids Chemical class 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- HWGNBUXHKFFFIH-UHFFFAOYSA-I pentasodium;[oxido(phosphonatooxy)phosphoryl] phosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])(=O)OP([O-])([O-])=O HWGNBUXHKFFFIH-UHFFFAOYSA-I 0.000 description 3
- 150000003008 phosphonic acid esters Chemical class 0.000 description 3
- 150000003009 phosphonic acids Chemical class 0.000 description 3
- 229910052698 phosphorus Inorganic materials 0.000 description 3
- 235000013772 propylene glycol Nutrition 0.000 description 3
- 150000003856 quaternary ammonium compounds Chemical class 0.000 description 3
- 229920006395 saturated elastomer Polymers 0.000 description 3
- 239000003352 sequestering agent Substances 0.000 description 3
- 239000010935 stainless steel Substances 0.000 description 3
- 229910001220 stainless steel Inorganic materials 0.000 description 3
- 239000000758 substrate Substances 0.000 description 3
- OVSKIKFHRZPJSS-UHFFFAOYSA-N 2,4-D Chemical compound OC(=O)COC1=CC=C(Cl)C=C1Cl OVSKIKFHRZPJSS-UHFFFAOYSA-N 0.000 description 2
- PQHYOGIRXOKOEJ-UHFFFAOYSA-N 2-(1,2-dicarboxyethylamino)butanedioic acid Chemical compound OC(=O)CC(C(O)=O)NC(C(O)=O)CC(O)=O PQHYOGIRXOKOEJ-UHFFFAOYSA-N 0.000 description 2
- URDCARMUOSMFFI-UHFFFAOYSA-N 2-[2-[bis(carboxymethyl)amino]ethyl-(2-hydroxyethyl)amino]acetic acid Chemical compound OCCN(CC(O)=O)CCN(CC(O)=O)CC(O)=O URDCARMUOSMFFI-UHFFFAOYSA-N 0.000 description 2
- QCDWFXQBSFUVSP-UHFFFAOYSA-N 2-phenoxyethanol Chemical compound OCCOC1=CC=CC=C1 QCDWFXQBSFUVSP-UHFFFAOYSA-N 0.000 description 2
- QGZKDVFQNNGYKY-UHFFFAOYSA-O Ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 description 2
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical group N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
- 229910001369 Brass Inorganic materials 0.000 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 2
- DBVJJBKOTRCVKF-UHFFFAOYSA-N Etidronic acid Chemical compound OP(=O)(O)C(O)(C)P(O)(O)=O DBVJJBKOTRCVKF-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- JYXGIOKAKDAARW-UHFFFAOYSA-N N-(2-hydroxyethyl)iminodiacetic acid Chemical compound OCCN(CC(O)=O)CC(O)=O JYXGIOKAKDAARW-UHFFFAOYSA-N 0.000 description 2
- UFWIBTONFRDIAS-UHFFFAOYSA-N Naphthalene Chemical class C1=CC=CC2=CC=CC=C21 UFWIBTONFRDIAS-UHFFFAOYSA-N 0.000 description 2
- 229910018828 PO3H2 Inorganic materials 0.000 description 2
- SJEYSFABYSGQBG-UHFFFAOYSA-M Patent blue Chemical compound [Na+].C1=CC(N(CC)CC)=CC=C1C(C=1C(=CC(=CC=1)S([O-])(=O)=O)S([O-])(=O)=O)=C1C=CC(=[N+](CC)CC)C=C1 SJEYSFABYSGQBG-UHFFFAOYSA-M 0.000 description 2
- KFSLWBXXFJQRDL-UHFFFAOYSA-N Peracetic acid Chemical compound CC(=O)OO KFSLWBXXFJQRDL-UHFFFAOYSA-N 0.000 description 2
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 2
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 2
- YDONNITUKPKTIG-UHFFFAOYSA-N [Nitrilotris(methylene)]trisphosphonic acid Chemical compound OP(O)(=O)CN(CP(O)(O)=O)CP(O)(O)=O YDONNITUKPKTIG-UHFFFAOYSA-N 0.000 description 2
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 description 2
- 150000001298 alcohols Chemical class 0.000 description 2
- 150000001447 alkali salts Chemical class 0.000 description 2
- 150000008055 alkyl aryl sulfonates Chemical class 0.000 description 2
- 150000008051 alkyl sulfates Chemical class 0.000 description 2
- 239000004599 antimicrobial Substances 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 239000011324 bead Substances 0.000 description 2
- XIWFQDBQMCDYJT-UHFFFAOYSA-M benzyl-dimethyl-tridecylazanium;chloride Chemical compound [Cl-].CCCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 XIWFQDBQMCDYJT-UHFFFAOYSA-M 0.000 description 2
- LLEMOWNGBBNAJR-UHFFFAOYSA-N biphenyl-2-ol Chemical compound OC1=CC=CC=C1C1=CC=CC=C1 LLEMOWNGBBNAJR-UHFFFAOYSA-N 0.000 description 2
- 229960002836 biphenylol Drugs 0.000 description 2
- 239000010951 brass Substances 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- QMVPMAAFGQKVCJ-UHFFFAOYSA-N citronellol Chemical compound OCCC(C)CCC=C(C)C QMVPMAAFGQKVCJ-UHFFFAOYSA-N 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000001010 compromised effect Effects 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- 239000010949 copper Substances 0.000 description 2
- 229910052802 copper Inorganic materials 0.000 description 2
- RWGFKTVRMDUZSP-UHFFFAOYSA-N cumene Chemical class CC(C)C1=CC=CC=C1 RWGFKTVRMDUZSP-UHFFFAOYSA-N 0.000 description 2
- 125000004122 cyclic group Chemical group 0.000 description 2
- 230000001627 detrimental effect Effects 0.000 description 2
- WJJMNDUMQPNECX-UHFFFAOYSA-N dipicolinic acid Chemical compound OC(=O)C1=CC=CC(C(O)=O)=N1 WJJMNDUMQPNECX-UHFFFAOYSA-N 0.000 description 2
- KSDGSKVLUHKDAL-UHFFFAOYSA-L disodium;3-[2-carboxylatoethyl(dodecyl)amino]propanoate Chemical compound [Na+].[Na+].CCCCCCCCCCCCN(CCC([O-])=O)CCC([O-])=O KSDGSKVLUHKDAL-UHFFFAOYSA-L 0.000 description 2
- 238000007046 ethoxylation reaction Methods 0.000 description 2
- MTZQAGJQAFMTAQ-UHFFFAOYSA-N ethyl benzoate Chemical class CCOC(=O)C1=CC=CC=C1 MTZQAGJQAFMTAQ-UHFFFAOYSA-N 0.000 description 2
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- 235000012207 sodium gluconate Nutrition 0.000 description 1
- 229940005574 sodium gluconate Drugs 0.000 description 1
- 235000019982 sodium hexametaphosphate Nutrition 0.000 description 1
- GCLGEJMYGQKIIW-UHFFFAOYSA-H sodium hexametaphosphate Chemical compound [Na]OP1(=O)OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])OP(=O)(O[Na])O1 GCLGEJMYGQKIIW-UHFFFAOYSA-H 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- GIPRGFRQMWSHAK-UHFFFAOYSA-M sodium;2-propan-2-ylbenzenesulfonate Chemical compound [Na+].CC(C)C1=CC=CC=C1S([O-])(=O)=O GIPRGFRQMWSHAK-UHFFFAOYSA-M 0.000 description 1
- KHKRPRQZEUYKNE-UHFFFAOYSA-M sodium;3-[2-(2-heptyl-4,5-dihydroimidazol-1-yl)ethoxy]propanoate Chemical compound [Na+].CCCCCCCC1=NCCN1CCOCCC([O-])=O KHKRPRQZEUYKNE-UHFFFAOYSA-M 0.000 description 1
- LLKGTXLYJMUQJX-UHFFFAOYSA-M sodium;3-[2-carboxyethyl(dodecyl)amino]propanoate Chemical compound [Na+].CCCCCCCCCCCCN(CCC(O)=O)CCC([O-])=O LLKGTXLYJMUQJX-UHFFFAOYSA-M 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 125000001424 substituent group Chemical group 0.000 description 1
- 239000011593 sulfur Chemical group 0.000 description 1
- 239000001117 sulphuric acid Substances 0.000 description 1
- 235000011149 sulphuric acid Nutrition 0.000 description 1
- 210000001179 synovial fluid Anatomy 0.000 description 1
- UJMBCXLDXJUMFB-GLCFPVLVSA-K tartrazine Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)C1=NN(C=2C=CC(=CC=2)S([O-])(=O)=O)C(=O)C1\N=N\C1=CC=C(S([O-])(=O)=O)C=C1 UJMBCXLDXJUMFB-GLCFPVLVSA-K 0.000 description 1
- 235000012756 tartrazine Nutrition 0.000 description 1
- 239000004149 tartrazine Substances 0.000 description 1
- 150000003505 terpenes Chemical class 0.000 description 1
- 235000019818 tetrasodium diphosphate Nutrition 0.000 description 1
- GYBINGQBXROMRS-UHFFFAOYSA-J tetrasodium;2-(1,2-dicarboxylatoethylamino)butanedioate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CC(C([O-])=O)NC(C([O-])=O)CC([O-])=O GYBINGQBXROMRS-UHFFFAOYSA-J 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 229910001428 transition metal ion Inorganic materials 0.000 description 1
- JSPLKZUTYZBBKA-UHFFFAOYSA-N trioxidane Chemical compound OOO JSPLKZUTYZBBKA-UHFFFAOYSA-N 0.000 description 1
- UNXRWKVEANCORM-UHFFFAOYSA-I triphosphate(5-) Chemical compound [O-]P([O-])(=O)OP([O-])(=O)OP([O-])([O-])=O UNXRWKVEANCORM-UHFFFAOYSA-I 0.000 description 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K tripotassium phosphate Chemical compound [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 1
- 235000019801 trisodium phosphate Nutrition 0.000 description 1
- 238000004506 ultrasonic cleaning Methods 0.000 description 1
- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 description 1
- 235000012141 vanillin Nutrition 0.000 description 1
- FGQOOHJZONJGDT-UHFFFAOYSA-N vanillin Natural products COC1=CC(O)=CC(C=O)=C1 FGQOOHJZONJGDT-UHFFFAOYSA-N 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 239000008403 very hard water Substances 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000011179 visual inspection Methods 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
- 239000008096 xylene Substances 0.000 description 1
- 239000002888 zwitterionic surfactant Substances 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/37—Polymers
- C11D3/3703—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- C11D3/3707—Polyethers, e.g. polyalkyleneoxides
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/0005—Other compounding ingredients characterised by their effect
- C11D3/0073—Anticorrosion compositions
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/26—Organic compounds containing nitrogen
- C11D3/30—Amines; Substituted amines ; Quaternized amines
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/16—Organic compounds
- C11D3/26—Organic compounds containing nitrogen
- C11D3/33—Amino carboxylic acids
-
- C—CHEMISTRY; METALLURGY
- C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
- C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
- C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
- C11D3/43—Solvents
Definitions
- the disclosure pertains to non-enzymatic compositions useful for cleaning surgical, medical and dental instruments and flexible endoscopes prior to reuse.
- the disclosure pertains to liquid concentrate non-enzymatic compositions useful for cleaning such instruments prior to a disinfection process, as well as to methods for use of the non-enzymatic compositions in such treatments.
- reusable medical instruments such as surgical instruments or probes, including flexible endoscopes
- reusable medical instruments are typically contaminated with blood and other body matter and potentially with infectious microorganisms during use and require cleaning and sterilization / disinfection after each use to ensure that the risks of cross infection from patient-to-patient as well as from patient-to-health care personnel are minimized.
- Surgical instruments including flexible endoscopes are normally pre-cleaned prior to automatic cleaning and disinfection.
- Manual pre-cleaning with the help of brushing serves to remove macroscopic soil rests and to free any present clogging sites which may not be successfully cleaned in the machine.
- a typical cycle for automatic cleaning of medical instruments consists of a number of consecutive stages: pre-wash, wash, rinses (usually two) and drying.
- the pre-wash stage is primarily used to dissolve blood on the instruments and may be run with a suitable wash solution.
- the wash part of the cycle is run with a wash solution which typically contains or more surfactants. Both the pre-wash and wash solutions may additionally contain one or more enzymes. Wash time, water temperature, surfactant selection, and wash solution concentration levels can vary depending upon the particular nature of the instrument and/or soil to be cleaned therefrom.
- the purpose of the rinse stage(s) is primarily to remove soil dissolved in the pre-wash and /or wash stage(s) as well as to remove any remaining surfactant-containing wash solution.
- Medical instruments that are thermally stable such as scissors, knives or scalpels, may be sterilized by processing at a high temperature.
- cleaning compositions which do not contain one or more enzymes are generally formulated at alkaline pH levels.
- the use of extreme pH levels in cleaning compositions, whether highly acidic or highly alkaline can introduce additional contamination risks in the medical, surgical and dental fields due to material incompatibility effects.
- US 2014/311529 discloses a detergent composition for endoscope washers, including a non-ionic surfactant represented by the formula R-O-[(EO)m/(PO)n]-H, a branched-chain fatty acid having not less than 6 and not more than 10 carbon atoms or a salt thereof, a defoaming agent and water.
- WO 2006/086875 discloses a method for cleaning dental and medical instruments, in which a cleaning solution including a low-residue corrosion inhibitor is used not only in a wash stage of the cleaning cycle, but also in at least one subsequent cycle.
- the cleaning solution has a neutral to alkaline pH and comprises a low foaming surfactant and a corrosion inhibitor selected from the group of C4 - C16 alkyl pyrrolidones and C1 - C18 alkylamines.
- Typical non-enzyme containing cleaning compositions as are known in the art are aggressive and often use moderately or even highly alkaline conditions to provide a high cleaning performance.
- a metal surface which has been compromised, via corrosion or other degradation processes may include cracks or pits which are potential additional sites for bacterial colonies to be established. Once corroded, such articles may require repair to re-establish the integrity of the metal surface, such as via coating processes, or even replacement of the entire instrument. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter from metal surfaces and which have reduced risk of post-cleaning soil retention.
- Novel non-enzymatic cleaning compositions are provided that are particularly suitable for manual cleaning of articles, and in particular surgical, medical or dental instruments including probes and flexible endoscopes.
- novel liquid concentrate non-enzymatic cleaning compositions provide desirable cleaning performance levels in comparison to neutral enzyme-including compositions.
- the novel liquid concentrate non-enzymatic cleaning compositions provide desirable cleaning performance levels across a broad range of in use concentrations in comparison to neutral enzyme-including compositions.
- novel liquid concentrate non-enzymatic cleaning compositions have improved material compatibility in comparison to conventional highly alkaline non-enzyme containing compositions.
- the novel liquid concentrate non-enzymatic cleaning compositions are low or no foaming at in use concentration levels; provide low foaming in use (dilute) solutions across a broad range of concentration levels, from 0.2% to 2.0%; provide a cleaning or wash solution which at in use concentration levels is not cloudy at temperatures of up to and including 45°C; are stable across a range of storage conditions in concentrated (undiluted) form; are stable across a range of hardness conditions at in aqueous solutions at in use concentration levels, such as for example up to and including 23 degrees of hardness, on the German hardness scale ( 0 dH DE); demonstrate good material compatibility.
- the low foaming surfactant system comprising at least one nonionic surfactant may comprise from about 1 to about 15 weight % of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer.
- the at least one complexing agent may comprise one or more super-complexing agents and optionally one or more complexing agents as defined hereinafter.
- the at least one complexing agent comprises one or more small molecule organic super-complexing agents and especially methylglycine diacetic acid (MGDA) and acid or alkali metal salts thereof.
- MGDA methylglycine diacetic acid
- the at least one source of alkalinity may comprise one or more amines.
- the at least one source of alkalinity comprises an alkanolamine independently selected from: triethanolamine (TEA); TEA 99%; monoethanolamine (MEA); diethanolamine (DEA); and combinations or mixtures thereof.
- the moderately alkaline pH level may comprise a pH in the range of from 7 to 12; from 8 to 10; from 8.5 to 9.5, about 9.5.
- the at least one anti-corrosion agent may comprise one or more phosphoric acid esters, and/or one or more phosphonic acid esters.
- the at least one corrosion inhibitor is a phosphate ester independently selected from phosphoric acid, 2-ethylhexyl ester, commercially available from Clariant as Hordaphos® MDAH, or phosphoric acid, mixed esters with butyl alcohol and ethylene glycol, commercially available as Hordaphos® MDGB.
- a non-enzymatic cleaning composition can comprise a low foaming surfactant system comprising at least one nonionic surfactant, at least one complexing agent, optionally at least one anti-corrosion agent, at least one source of alkali and a moderately alkaline pH level.
- the cleaning composition has a pH of about 9.5.
- the low foaming surfactant system comprising at least one nonionic surfactant is present in the cleaning composition in an amount ranging from about 0.1 to 15.0 weight %, the at least one complexing agent is present in an amount ranging from about 0.1 to 10.0 weight %, the at least one source of alkalinity is present in an amount ranging from about 0.1 to 10.0 weight %, optionally, the at least one anti-corrosion agent is present in an amount ranging from about 0 to 5 weight %, and the cleaning composition has a pH of about 9.5.
- the low foaming surfactant system comprising at least one nonionic surfactant is present in the cleaning composition in an amount ranging from about 2.0 to 10.0 weight % the at least one complexing agent is present in an amount ranging from about 2.0 to 8.0 weight %, the at least one source of alkalinity is present in an amount ranging from about 3.0 to 8.0 weight % and the cleaning composition has a pH of: from 8 to 10; from 8.5 to 9.5; or about 9.5.
- non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- the articles to be cleaned are metal articles and the step of cleaning the article with the novel non-enzymatic cleaning composition is carried out manually.
- the methods can include the steps of providing an article to be cleaned and directly applying an effective amount of the novel non-enzymatic cleaning composition to the article, either in diluted form or as a concentrated solution, and cleaning of the article therewith, followed by at least one rinsing step, and optionally at least one further cleaning and washing cycle.
- the methods can include the steps of providing an article to be cleaned, providing an effective amount of the novel non-enzymatic cleaning composition in an aqueous solution and cleaning the article with/in the dilute aqueous solution containing the novel non-enzymatic cleaning composition.
- the novel non-enzymatic cleaning composition is at least partially diluted to form a concentrated or a dilute aqueous solution prior to use.
- the step of cleaning the article with the novel non-enzymatic cleaning composition is carried out automatically.
- An effective amount of the novel non-enzymatic cleaning composition is preferably such that desirable foam levels, solution clarity (turbidity), cleaning efficacy (particularly cleaning of blood and/or blood-based soils are provided using the composition after dilution to provide an aqueous solution of the composition prior to use.
- an effective amount of the novel non-enzymatic cleaning composition is preferably such that desirable foam levels, solution clarity (turbidity), cleaning efficacy (blood / blood-based soil cleaning), and material compatibility (anti-corrosive effects) are provided using the composition after dilution to provide an aqueous solution of the composition prior to use.
- an effective amount of the novel non-enzymatic cleaning composition is such that the amount of the low foam surfactant system comprising at least one nonionic surfactant ranges from about 0.1 to 15.0 weight %, the amount of the at least one complexing agent is present in an amount ranging from about 0.1 to 10.0 weight %, and the amount of the at least one source of alkalinity is present in an amount ranging from about 0.1 to 10.0 weight % and the cleaning composition is then diluted with water to between 10% original concentration to 0.1% original concentration.
- the concentrated non-enzymatic cleaning composition may be diluted with a suitable aqueous solvent to 10%, 5%, 2%, 1%, 0.5% or preferably 0.2% of the original composition concentration prior to use i.e. a 10% aqueous solution of the composition.
- a suitable aqueous solvent to 10%, 5%, 2%, 1%, 0.5% or preferably 0.2% of the original composition concentration prior to use i.e. a 10% aqueous solution of the composition.
- the choice of dilution for any particular in-use aqueous cleaning solution will be dependent upon the level or soil, the type of soil, the time the soil has been left on the surface, as well as the hardness of the water used to dilute the composition.
- any particular component in the compositions herein are expressed in terms of % weight this means the amount of the component relative to the total amount of the composition.
- 6% of a source of alkalinity in a cleaning composition herein means that 100g (100%) of the composition contains 6g (6%) of said source of alkalinity.
- the present disclosure provides non-enzymatic compositions useful for cleaning surgical, medical and dental instruments and flexible endoscopes prior to reuse.
- the disclosure provides liquid concentrate non-enzymatic compositions useful for cleaning such instruments prior to disinfection, as well as to methods for use of the non-enzymatic compositions in such cleaning treatments.
- liquid concentrate compositions herein may be applied directly to an article to be cleaned without dilution, or may be applied as concentrated solutions to an article to be cleaned, or may be diluted to form aqueous in use solutions into which articles to be cleaned may be immersed and cleaned.
- cleaning as used herein in terms of liquid concentrate, or in-use solutions thereof means suitable for use in cleaning wherein cleaning as defined herein means the removal of soils, marks, stains, dirt or other material from the surface of an item.
- the present compositions are formulated to have at least a moderately alkaline pH level both on manufacture of a finished liquid concentrate, and when in-use as a diluted solution.
- a moderately alkaline pH level as defined herein is a pH of from about pH 7 to about pH 10.5.
- the non-enzymatic compositions herein have a finished pH of: at least 7.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and about 9.5.
- non-enzymatic cleaning compositions which additionally are formulated to have a finished pH of: at least 7.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and about 9.5.
- the finished pH of a liquid concentrate composition as detailed herein is the final pH of the composition following pH adjustment with acid or base as necessary to bring the pH into line with the desired levels of from about 7.5 to about 10.5, and preferably about pH 9.5.
- the pH of an in-use solution where the liquid concentrate has been diluted with water will substantially correspond to the pH of the original liquid concentrate and ideally be within 0.1 to 1, or 0.5 to 1 pH unit of the finished pH level.
- Any suitable form of water may be used to provide an in-use solution, de-ionized (DI), or tap water.
- DI de-ionized
- tap water will be used, in which case the water will have a defined hardness level (the degree of hardness).
- the cleaning performance of certain aspects is particularly effective in the removal of dried body fluids, and especially of dried blood.
- compositions provide low, or no foaming use solutions at temperatures of up to and including 45°C.
- a low foaming or no foaming use solution as defined herein is a solution having an initial foam height of less than about 5cm, and reducing to 0cm between about 10 seconds and 1 minute as measured in accordance with the manual shaking methodology detailed in the Experimental Methods section herein.
- compositions provide crystal clear use solutions at temperatures of up to and including 45°C and at water hardness levels of up to and including 23 degrees of Hardness (23° dH) on the German water hardness scale.
- a crystal clear use solution as defined herein is a solution having which is clear to the naked eye both on initial formulation, and after pH finishing.
- the present compositions provide desirable cleaning performance when compared to enzymatic cleansers.
- the efficacious cleaning abilities of the present compositions are especially effective in the removal of blood based soils.
- the present moderately alkaline non-enzymatic cleaning compositions have been demonstrated to provided material compatibilities consistent with neutral pH multi-enzyme containing cleaning compositions, and improved material compatibility (reduced corrosive potential) versus baseline (standard) alkaline pH non-enzyme containing compositions. These results are especially surprising because it is widely known that increasing the pH in cleaning compositions carries an increased risk of material incompatibility in some metal substrates.
- the present non-enzymatic cleaning compositions have been demonstrated to provide performance levels, and especially blood soil removal performance levels which are consistent with multi-enzyme containing cleaning compositions.
- the present compositions show faster soil removal performance versus enzyme containing cleaning compositions. These faster cleaning results are particularly surprising because to date, enzymes have been considered to be the "gold-standard" for blood soil removal.
- compositions provide desirable cleaning and anti-corrosive performance levels, and are particularly effective in the removal of dried body fluids, and especially of dried blood and in the inhibition of corrosion of anodized aluminum.
- the present invention can be a liquid concentrate composition comprising based on the whole composition from about 0.1 to about 15 wt. %, from about 0.1 to about 10 wt. %, from about 0.1 to about 6 wt. %, from about 0.1 to about 4 wt. %, from about 1 to about 6 wt. %, from about 1 to about 4 wt. % of a low-foam surfactant system comprising at least one nonionic surfactant.
- compositions comprise from 1 to 15% of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer.
- the composition includes at least two nonionic surfactants selected from one or more PO/EO/PO block copolymers and one or more ethoxylated amine block copolymers.
- compositions comprise from 1 to 15% of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer, and optionally further surfactants wherein said further surfactants preferably comprise one or more additional non-ionic surfactants.
- nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer
- further surfactants wherein said further surfactants preferably comprise one or more additional non-ionic surfactants.
- Suitable PO/EO/PO block copolymers for use herein include compounds of general formula A: HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60.
- the corresponding values of x and y will be dependent upon the particular EO : PO range for any particular block copolymer.
- a PO : EO : PO block copolymer having a weight ratio of total EO to total PO of 40 : 60 and a molecular weight of 2650 will have values of x and y of about 24 for y and about 13 to 14 for x.
- Exemplary PO/EO/PO block copolymers of formula suitable for use herein include the Pluronic and reverse Pluronic nonionic surfactant ranges from (BASF), and in particular the Pluronic RPE range including Pluronic® RPE 1720, Pluronic® RPE 1740, Pluronic® RPE 2035, Pluronic® RPE 2520, Pluronic® RPE 2525, Pluronic® RPE 3110 and mixtures and combinations thereof.
- RPE 1720 having a molecular weight of 2150
- RPE 1740 having a molecular weight of 2650
- RPE 2035 having a molecular weight of 4100
- RPE 2520 having a molecular weight of 3100
- RPE 2525 having a molecular weight of 2000
- RPE 3110 having a molecular weight of 3500.
- the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level of from about 0.1 weight % to about 15 weight % and includes at least one PO/EO/PO block copolymer of formula HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650.
- the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from : about 0.1 weight % to about 10 weight %; from about 0.1 weight % to about 6%; from about 0.1 weight % to about 4 weight %, and includes at least one PO/EO/PO block copolymer of formula HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500
- the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from : about 0.1 weight % to about 10 weight %; from about 0.1 weight % to about 6%; from about 0.1 weight % to about 4 weight %, and is an PO/EO/PO block copolymer of formula HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about
- the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is a PO/EO/PO block copolymer having an EO : PO weight ratio of 40 : 60 and a molecular weight of 2650.
- An exemplary PO/EO/PO PO block copolymer having an EO : PO weight ratio of 40 :60 and a molecular weight of 2650 is PL1740.
- the present invention provides a non-enzymatic liquid concentrate cleaning composition wherein the nonionic surfactant is PL1740.
- Suitable ethoxylated amine block copolymers for use herein include alkoxylated ethylene diamines.
- alkoxylated ethylene diamines for use herein are the Synperonic T series which are commercially available from Croda, Genapol ED 3030 and Genapol ED 3060 which are available from Clariant.
- Synperonics for use herein include: SYNPERONIC T/304, alkoxylated ethylene diamine having a molecular weight of 1650; SYNPERONIC T/701, alkoxylated ethylene diamine having a molecular weight of 3600; SYNPERONIC T/707, alkoxylated ethylene diamine having a molecular weight of 25000; SYNPERONIC T/904, alkoxylated ethylene diamine having a molecular weight of 7500; and SYNPERONIC T/908, alkoxylated ethylene diamine having a molecular weight of 25000.
- the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level independently selected from: about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and includes at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650.
- the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %; from about 0.1 weight % to about 4 weight %, and is an alkoxylated ethylene diamine.
- the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is an alkoxylated ethylene diamine having a molecular weight of 1650.
- the nonionic surfactant is an alkoxylated ethylene diamine having a molecular weight of 1650.
- An exemplary alkoxylated ethylene diamine having a molecular weight of 1650 is Synperonic T/304, available from Croda.
- the present invention provides a non-enzymatic liquid concentrate cleaning composition wherein the nonionic surfactant is Synperonic T/304.
- the at least one low foam nonionic comprises Synperonic® T/304.
- the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000;
- the at least one low foam nonionic comprises a combination of a Pluronic RPE and a Synperonic T, and in particular Pluronics® RPE1740 and Synperonic® T/304 wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %; from about 0.1 weight % to about 4 weight %.
- compositions according to the invention have been demonstrated to show low foaming at in use concentration and gives a solution which in use concentration is not cloudy at a temperature in the range from 0 to 45°C.
- liquid compositions according to the present invention have been demonstrated to provide good cleaning efficacy.
- Suitable additional nonionic surfactants for use herein include the Dehydol, Lankropol, Genapol and Hoesch ranges of surfactants.
- Exemplary additional non-ionic surfactants for use herein include: fatty alcohol ethoxylate C 10 - C 16 with 1.2 moles PO and 6.4 moles EO commercially available as Dehydol® 980, from BASF; fatty acid sulphonate commercially available as Lankropol OPA, from AkzoNobel; C 12 /C 15 oxo alcohol PO-EO adduct commercially available from Clariant as Genapol EP 2552; and C 12 -C 14 fatty alcohol alkoxylate 2EO/4PO copolymer commercially available as Hoesch FA 42 LF, from Julius Hoesch; and combinations and mixtures thereof.
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the surfactant is independently selected from: at least one PO/EO/PO block of formula HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is from about 10 : 90 to about 90 :10, from about 20 : 80 to about 80 : 20, from about 30 : 70 to about 70 : 30, from about 40 : 60 to from about 60 :40, or about 40 : 60 and wherein the copolymer has a molecular weight in the range of from about 2000 to about 4500, from about 2500 to about 3500, or about 2650; at least one ethoxylated amine block cop
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the surfactant is present at a level of from about 0.1% to about 10%, from about 2% to about 8%, from about 3 weight % to about 7 weight %, or about 6 weight %, and especially wherein the surfactant is independently selected from: Pluronic 1740 at a level of from about 3 weight % to about 7 weight %, or about 6 weight %; Synperonic T/304 at a level of from about 1 weight % to about 10 weight %.
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent: source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6.
- the invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3.
- compositions herein include one or more complexing agents at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, from about 2 weight % to about 5 weight %.
- a complexing agent or a sequestrant is a molecule capable of coordinating (i.e., binding) the metal ions commonly found in natural water to prevent those metal ions from interfering with the action of other detersive ingredients such as surfactants in a cleaning composition.
- Some complexing agents can also function as threshold agents when included in an effective amount.
- complexing agent as generally defined herein is one or more agents which are capable of coordinating with metal ions in the wash water, when the compositions are used either as concentrated or diluted aqueous solutions, in order to form stable or transiently stable metal-complexes.
- a stable metal complex as defined herein is a complex which binds the metal ions is such a manner that they cannot interfere with the cleaning process, and in some instances such complexes may advantageously precipitate out of solution during the washing process and be simply rinsed away.
- complexing agents are not only capable of coordinating with metal ions in natural or wash water as discussed herein but are also capable of binding with metallic components within a body soil to be removed during the cleaning process.
- certain complexing agents may additionally be capable of binding to Ca-bridges within the protein-based elements of such soil and by such action enhance soil break-down and removal during the cleaning process.
- the one or more super-complexing agents for use herein includes at least one complexing agents which is capable of coordinating with metal ions in natural or wash water and is capable of binding with metallic components within a body soil to be removed during the cleaning process.
- Super-complexing agents for use herein include one or more small molecule organic complexing agents including aminocarboxylic acid type sequestrants.
- Suitable aminocarboxylic acid type sequestrants include the acids or alkali metal salts thereof, e.g., amino acetates and salts thereof.
- N-hydroxyethylaminodiacetic acid hydro xyethylenediaminetetraacetic acid, nitrilotriacetic acid (NTA); methylglycine diacetic acid (MGDA); 2-hydroxyethyliminodiacetic acid (HEIDA); ethylenediamine tetraacetic acid (EDTA); N-hydroxyethyl-ethylenediaminetriacetic acid (HEDTA); diethylenetriammepentaacetic acid (DTPA); ethyloenediamine-tetrapropionic acid triethylentetraaminehexaacetic acid (TTHSA), and alanine-N,N-diacetic acid; N,N-diacetic acid (GLDA), methylglycinediacetic acid (MGDA), iminodisuccinate (IDS) and the like; and the respective alkali metal ammonium and substituted ammonium salts thereof; and combinations or mixtures thereof.
- NTA hydro xyethylenediamine
- Preferred herein as small molecule organic super-complexing agents are materials which when utilised in liquid concentrate compositions provide desirable cleaning performance, particularly versus blood / blood-based soils.
- Preferred small molecule organic super-complexing agents for use herein include: methylglycinediacetic acid (MGDA), and salts thereof, and especially the tri-sodium salt, commercially available from BASF as Trilon® M Liquid, and particularly where utilized as a 40% aqueous solution.
- MGDA methylglycinediacetic acid
- Trilon® M Liquid commercially available from BASF as Trilon® M Liquid, and particularly where utilized as a 40% aqueous solution.
- Trilon M grades include: Trilon® M Compactate, Trilon® M Granules SG, Trilon® M Granules, Trilon® M Liquid, Trilon® M Powder
- the at least one super complexing agent comprises MGDA.
- the at least one super complexing agent comprises GLDA.
- GLDA-Na 4 N,N-diacetic acid tetra sodium salts, also known as L-glutamic acid tetra sodium salt of tetrasodium N,N-bis(carboxymethyl)-L-glutamate, available as Dissolvine GL-47-S (47% liquid), Dissolvine-PD-S (micro-granular) and Dissolvine-38 (38% liquid) from Akzo Nobel.
- liquid concentrate composition herein includes one or more complexing agents wherein at least one complexing agent is a small molecule organic super-complexing agent.
- the liquid concentrate composition herein includes one or more complexing agents wherein at least one complexing agent is an aminocarboxylic acid or an acid or alkali metal salt thereof, and particularly wherein at least one complexing agent is methylglycinediacetic acid (MGDA), or an acid or alkali salt thereof.
- MGDA methylglycinediacetic acid
- the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and/or at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about
- the at least one low foam nonionic comprises a Pluronic RPE and/or Synperonic T nonionic surfactant, and in particular Pluronics® RPE1740 and/or Synperonic® T/304 wherein the level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and wherein the, and particularly wherein at least one complexing agent is methylglycinediacetic acid (MGDA), or an acid or alkali salt thereof present at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, or from about 2 weight % to about 5 weight %.
- MGDA methylglycinediacetic acid
- Additional, optional complexing agents for use in addition to the super-complexing agents can be included. Where one or more of such optional additional complexing agents is used the total level of such agents is from 0.01 weight % to about 1 weight %.
- Suitable additional optional complexing agents for use herein are not limited to organic chelating compounds which sequester metal ions in solution, particularly transition metal ions.
- a variety of suitable additional optional complexing agents can be used in the liquid concentrate cleaning compositions herein including, for example, organic amino- or hyroxy-polyphosphonic acid complexing agents (either in acid or soluble salt forms), carboxylic acids (e.g. polymeric polycarbonate), hydroxycarboxylic acids, aminocarboxylic acids, or heterocyclic carboxylic acids e.g. , pyridine-2-6-dicarboxylic acid (dipicolinic acid), condensed phosphates, inorganic builders, polymeric polycarboxylates, and the like, and combinations or mixtures thereof.
- Such complexing agents are
- Suitable condensed phosphates for use as additional complexing agents herein include sodium and potassium orthophosphate, sodium and potassium pyrophosphate, sodium and potassium tripolyphosphate, sodium hexametaphosphate.
- Exemplary commercially available additional complexing agents include: phosphonates sold under the trade name DEQUEST® from Thermos or Cublen® from Zschimmer & Schwarz or Briquest® from Rhodia including, for example, 1-hydroxyethylidine-1,1-diphosphonic acid (CH 3 C(PO 3 H 2 ) 2 OH) (HEDP) DEQUEST® 2010; amino(tri(methylenephosphonic acid)), (N[CH 2 PO 3 H 2 ] 3 ), available as DEQUEST® 2000, or as Cublen® AP5 from Zschimmer & Schwarz, or as Briquest® 301-50A from Rhodia; ethylenediamine[tetra (methylenephosphonic acid)], available from Thermphos as DEQUEST® 2041; diethylene triamine penta(methylene phosphonic acid), available from Thermphos as DEQUEST® 2066, or as Cublen® D 3217S from Zschimmer & Schwarz; 2-phosphonobutane-1,2-tricarboxylic acid available from
- the present compositions preferably contain 0.5 wt. % or less of phosphate.
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the complexing agent is independently selected from: methylglycinediacetic acid (MGDA) and/or and salts thereof, and especially the tri-sodium salt; glutamic acid, N,N-diacetic acid (GLDA) and/or and salts thereof, and especially the tetrasodium salt; and mixtures and combinations thereof.
- MGDA methylglycinediacetic acid
- GLDA N,N-diacetic acid
- tetrasodium salt and mixtures and combinations thereof.
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 and wherein the complexing agent is a small molecule organic super-complexing agent as defined herein, and particularly wherein the complexing agent is independently selected from: methylglycinediacetic acid (MGDA) and/or and salts thereof, and especially the tri-sodium salt; glutamic acid, N,N-diacetic acid (GLDA) and/or and salts thereof, and especially the tetrasodium salt; and mixtures and combinations thereof.
- MGDA methylglycinediacetic acid
- GLDA N,N-diacetic acid
- the invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3.
- the one or more additional complexing agents can include one or more organic phosphonates, such as an organic-phosphonic acid and alkali metal salts thereof.
- anti-corrosion agent or corrosion inhibitor is intended to refer to at least one of, or any combination of, the disclosed corrosion inhibitors, corrosion inhibitor intermediates, and corrosion inhibitor product formulations.
- a corrosion inhibitor as defined herein is an agent which either acts with or impacts upon another component in the cleaning composition such that the risk of surface damage (to the article to be cleaned) is reduced.
- an effective amount is intended to refer to an amount by which the referred to component is present to perform its intended function.
- an effective amount of a corrosion inhibitor is an amount of that component necessary to inhibit corrosion.
- novel liquid concentrate non-enzymatic cleaning compositions for cleaning surgical, medical and dental instruments and flexible endoscopes comprising:
- a liquid concentrate non-enzymatic cleaning composition as detailed hereinbefore comprising from 0.1 wt % to 5.0 wt. % of at least one anti-corrosion agent selected from one or more phosphoric acid esters, and/or one or more phosphonic acid esters.
- Suitable for use herein as anti-corrosion agents are alkyl esters of phosphoric acid, particularly mono or di-alkyl esters, phosphonic acids and esters thereof and combinations and mixtures thereof.
- Exemplary phosphate esters for use herein include: Hordaphos® MDAH, phosphoric acid, 2-ethylhexyl ester available from Clariant; Hordaphos® MDGB phosphoric acid, mixed esters with butyl alcohol and ethylene glycol available from Clariant; and combinations and mixtures thereof.
- non-enzymatic liquid concentrate compositions as defined according to any aspect herein include at least one anti-corrosion agent at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt %.
- the total level is within the levels defined hereinbefore and within 0.1 wt % to 5 wt %.
- the at least one anti-corrosion agent comprises Hordaphos® MDAH at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt. %.
- the at least one anti-corrosion agent comprises Hordaphos® MDGB at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt. %.
- the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH 3 )CH 2 O) x -(CH 2 CH 2 O) y -(CH(CH 3 )CH 2 O) x H wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about
- the anti-corrosion agent is an alkyl ester of phosphoric acid, particularly a mono or di-alkyl ester.
- the at least one low foam nonionic is a Pluronic RPE and/or a Synperonic T, and in particular Pluronics® RPE1740 and/or Synperonic® T/304 wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight % and wherein the anti-corrosion agent is independently selected from: Hordaphos® MDGB; Hordaphos® MDAH and mixtures and combinations thereof.
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 wherein the complexing agent is a small molecule organic super-complexing agent, and wherein the anti-corrosion agent is one or more alkyl esters of phosphoric acid.
- the invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent: source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3 and wherein the anti-corrosion agent is independently selected from Hordaphos® MDAH; Hordaphos® MDGB.
- Suitable optional, additional anti-corrosion agents for use herein include phosphonic acids and phosphonic acid esters also known as phosphonates thereof for use as corrosion inhibitors herein are include organic phosphonates, condensed phosphonates, or the like, and mixtures and combinations thereof.
- the at least one phosphonic acid may include a plurality of phosphonic acid or phosphonates including, for example, organic phosphonates, condensed phosphonates, mixtures thereof, or the like.
- Suitable condensed phosphonates include sodium and potassium orthophosphonates, sodium and potassium pyrophosphonate, sodium and potassium tripolyphosphonate, sodium hexametaphosphonate.
- organic phosphonic acids including their corresponding phosphonates include: Alkyl (C 1 -C 20 ) phosphonic acid: R[PO(OH) 2 ], where R is C 1 -C 20 ; 2-carboxy phosphonic acid: COOH[PO(OH) 2 ]; 2-carboxyalkyl (C 1 -C 20 ) phosphonic acid: COOHR[PO(OH) 2 ], where R is C 1 -C 20 ; 1 -hydroxyethane- 1 , 1 -diphosphonic acid: CH 3 C(OH)[PO(OH) 2 ] 2 ; aminotri(methylenephosphonic acid) : N[CH 2 PO(OH) 2 ] 3 ; aminotri (methylenephosphonate), sodium salt; 2-hydroxyethyliminobis(methylenephosphonic acid), HOCH 2 CH 2 N[CH 2 PO(OH) 2 ] 2 ; diethylenetriaminepenta(methylenephosphonic acid), (HO) 2 POCH 2 N[CH 2 CH
- the source of alkalinity can be any source of alkalinity that is compatible with the other components of the liquid concentrate non-enzymatic cleaning composition.
- exemplary sources of alkalinity include alkali metal hydroxides, alkali metal salts, phosphates, amines, and mixtures thereof.
- the alkalinity of a liquid concentrate composition as defined herein can be adjusted to provide a finished liquid concentrate composition having a desirable pH by adding the source of alkalinity until a pH-value of: at least 7.5; from about 7.5 to about 12; from about 7.5 to about 10.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and especially about 9.5 is achieved.
- the source of alkalinity is one or more amines.
- exemplary amines include alkanolamines selected from the group comprising triethanolamine (TEA), TEA 99%, monoethanolamine (MEA), diethanolamine (DEA), and mixtures thereof.
- TEA is a preferred amine for use herein.
- Exemplary alkali metal hydroxides include sodium hydroxide, potassium hydroxide, and lithium hydroxide.
- Alkali metal hydroxides are commercially available as pellets or beads having a mix of particle sizes ranging from 12-100 U.S. mesh, or as an aqueous solution, such as for example, as an about 45 wt.%, as an about 50 wt.%, or as an about 73 wt.% solution.
- a preferred form of sodium hydroxide is a 50% aqueous solution (caustic soda).
- Exemplary alkali metal salts include sodium carbonate, trisodium phosphate, potassium carbonate, and mixtures thereof.
- Exemplary phosphates include sodium pyrophosphate, potassium pyrophosphate, and mixtures thereof.
- a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 wherein the complexing agent is a small molecule organic super-complexing agent, wherein the anti-corrosion agent is one or more alkyl esters of phosphoric acid, and wherein the source of alkalinity is one or more amines, and especially one or more alkanolamines.
- the invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent: source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3 and wherein the source of alkalinity is an alkanolamine, particularly TEA.
- the source of alkalinity may be added to the composition in a variety of forms, including for example in the form of liquids (for amines), or as solid beads, dissolved in an aqueous solution or as a combination thereof (for alkali metal hydroxides).
- the source of alkalinity may comprises one or more different sources of alkalinity with the provision that the total level of the source of alkalinity in the present composition is form about 1 wt. % to about 10 wt. %, from about 2 wt. % to about 8 wt. %, from about 3 wt. % to about 6 wt. %, about 5 wt. % of the liquid concentrate non-enzymatic cleaning composition.
- the liquid detergent concentrate composition may optionally additionally include from 1 weight % to 20 weight % in total of one or more hydrotrope components. It is anticipated, that where present, the one or more hydrotrope components will provide added stability to the liquid concentrate cleaning compositions, primarily by stabilizing the nonionic surfactant component.
- hydrotropes examples include the sodium, potassium, ammonium and alkanol ammonium salts of xylene, toluene, ethylbenzoate, isopropylbenzene, naphthalene, alkyl naphthalene sulfonates, phosphate esters of alkoxylated alkyl phenols, phosphate esters of alkoxylated alcohols, short chain (C8 or less) alkyl polyglycoside, sodium, potassium and ammonium salts of the allcyl sarcosinates, salts of cumene sulfonates, amino propionates, diphenyl oxides, and disulfonates.
- one or more hydrotropes are present in the liquid concentrate cleaning compositions wherein the total level of hydrotrope is provided in an amount of about 1 weight % to about 20 weight %, preferably about 3 weight % to about 15 weight %, further preferred about 5 weight % to about 15 weight %, based on the weight of the liquid concentrate cleaning composition.
- the hydrotrope is a 40% aqueous solution of sodium cumene sulfonate (SCS).
- SCS sodium cumene sulfonate
- the hydrotrope is a 40% aqueous solution of sodium cumene sulfonate (SCS) present at a level of from 5 weight % to about 15 weight %, and preferably about 10 weight %.
- the non-enzymatic cleaning compositions may include such additional ingredients or forms of ingredients such as are typically found in manual cleaning compositions such as one or more additional surfactants, one or more dyes, one or more perfumes or odorants, one or more preservatives or antimicrobial agents, one or more hydrotropes, one or more pH adjusting agents, one or more corrosion inhibitors, one or more anti-foaming agents, one or more viscosity adjusting or formulation stabilising agents such as thickening agents.
- additional surfactants such as one or more dyes, one or more perfumes or odorants, one or more preservatives or antimicrobial agents, one or more hydrotropes, one or more pH adjusting agents, one or more corrosion inhibitors, one or more anti-foaming agents, one or more viscosity adjusting or formulation stabilising agents such as thickening agents.
- the liquid concentrate non-enzymatic cleaning compositions herein may comprise additional surfactants such as one or more cationic surfactants, one or more anionic surfactants, e.g., phosphate ester, alkyl amine oxide, one or more amphoteric so-called zwitterionic surfactants and combinations and mixtures thereof. Where present the total level of additional surfactants is from 0.1 to 10 weight %.
- non-enzymatic cleaning compositions herein are free of cationic surfactants. According to another aspect the non-enzymatic cleaning compositions herein are free of both cationic surfactants and amphoteric surfactants. According to one aspect the non-enzymatic liquid concentrate cleaning compositions additionally comprise from 1 to 10 weight % of one or more anionic surfactants, and optionally from 0.1 to 2 weight % of one or more anti-foaming agents.
- the non-enzymatic liquid concentrate cleaning composition can include from 1 to 10 weight % of one or more anionic surfactants, and optionally from 0.1 to 2 weight % of one or more anti-foaming agents.
- anionic surfactants that can be used include organic carboxylates, organic sulfonates, organic sulfates, organic phosphates and the like, particularly linear alkylaryl sulfonates, such as alkylarylcarboxylates, alkylarylsulfonates, alkylarylphosphates, and the like.
- anionic surfactants are known within the surfactant art as linear alkyl benzyl sulfonates (LABS), alpha olefin sulfonates (AOS), alkyl sulfates, and secondary alkane sulfonates.
- the anionic surfactants can be provided in the composition in an amount of from: 0 to about 10 weight%; from about 1 weight % to about 10 weight %; from about 2 weight % to about 9 weight %; from about 3 weight % to about 8 weight %; or about 5 weight %, based on the weight of the total non-enzymatic liquid concentrate cleaning composition, as defined hereinbefore.
- the non-enzymatic liquid concentrate cleaning compositions herein can include from 0.1 to 1 weight % of one or more cationic surfactants. Where the composition includes one or more anionic surfactants no cationic surfactant is present.
- Suitable cationic surfactants include quaternary ammonium compounds having the formula of RR'R"R"N + X - , where R, R, R" and R'" are each a C 1 -C 24 alkyl, aryl or arylalkyl group that can optionally contain one or more P, O, S or N heteroatoms, and X is F, CI, Br, I or an alkyl sulfate.
- Each of R, R, R" and R'" can independently include, individually or in combination, substituents including 6 to 24 carbon atoms, preferably 14 to 24 carbon atoms, and more preferably, 16 to 24 carbon atoms.
- Each of R, R', R" and R'" can independently be linear, cyclic, branched, saturated, or unsaturated, and can include heteroatoms such as oxygen, phosphorous, sulfur, or nitrogen. Any two of R, R, R" and R'” can form a cyclic group. Any one of three of R, R, R" and R'” can independently be hydrogen.
- X is preferably a counter ion and preferably a non- fluoride counter ion. Exemplary counter ions include chloride, bromide, methosulfate, ethosulfate, sulfate, and phosphate.
- the quaternary ammonium compound includes alkyl ethoxylated and/or propoxylated quaternary ammonium salts (or amines).
- Preferred alkyl groups contain between about 6 and about 22 carbon atoms and can be saturated and/or unsaturated.
- the degree of ethoxylation is preferably between about 2 and about 20, and/or the degree of propoxylation is preferably between about 0 and about 30.
- the quaternary ammonium compound includes an alkyl group with about 6 to about 22 carbon atoms and a degree of ethoxylation between about 2 and about 20.
- An exemplary cationic surfactant is commercially available under the name Berol 563 from Akzo-Nobel.
- Additional cationic surfactants suitable for use include ethoxylated and/or propoxylated alkyl amines, diamines, or triamines.
- the non-enzymatic liquid concentrate cleaning compositions herein can include from 0.1 to 5 weight % of one or more amphoteric surfactants.
- suitable amphoteric surfactants include capryloamphopropionate, disodium lauryl B-iminodipropionate, cocoamphocarboxypropionate, and disodium octylimino dipropionate.
- amphoteric surfactants can be provided in the composition in an amount of about 0 weight % to about 5 weight %; from 0.1 to 5 weight %, 1 to 5 weight %; 2 to 5 weight %, based on the weight of the total liquid concentrate composition.
- the pH value of the non-enzymatic liquid concentrate cleaning composition herein can be adjusted by adding an acidic or basic pH adjusting agent.
- the selection of any particular agent will be dependent upon the starting pH of the liquid concentrate cleaning composition, or in use solution to be adjusted, and desired pH to be achieved.
- the pH adjusting agent is provided as part of the liquid concentrate cleaning composition.
- the pH adjusting agent can be provided in a form that allows it to take effect at a certain point in time during the manual or automatic washing process i.e. during use.
- the pH adjusting agent can be coated in a manner that provides for release of the pH adjusting agent after a length of time.
- the pH-adjusting agent can be a component that is generated as a result of a reaction.
- the pH-adjusting agent can provide the desired pH shift to a second pH after the composition has been provided at the first pH for a desired length of time.
- the pH adjusting agent When used to increase the pH, it can be referred to as an alkaline agent.
- exemplary alkaline agents that can be used has been already mentioned above and referred to as "source of alkalinity”.
- Triethylamine (TEA) and particularly 99% TEA is a preferred source of alkalinity herein.
- an acidifying agent When the pH adjusting agent is used to lower the pH, it can be referred to as an acidifying agent.
- exemplary acidifying agents include inorganic acids, organic acids, and mixtures of inorganic acids and organic acids.
- Exemplary inorganic acids that can be used include mineral acids such as sulphuric acid, nitric acid, hydrochloric acid, and phosphoric acid.
- Exemplary organic acids that can be used include carboxylic acids including monocarboxylic acids and polycarboxylic acids such as dicarboxylic acids.
- Exemplary carboxylic acids include aliphatic and aromatic carboxylic acids.
- Exemplary aliphatic carboxylic acids include acetic acid, formic acid, halogen-containing carboxylic acids such as chloroacetic carboxylic acid, and modified carboxylic acids containing side groups such - OH, - R, - OR, -(EO) x , - (PO) x , - NH 2 , and- NO 2 wherein R is a C 1 to C 10 alkyl group.
- Exemplary aromatic carboxylic acids include benzoic carboxylic acid, salicylic carboxylic acid, and aromatic carboxylic acid modified to include as a side group at least one of halogen, - OH, - R, - OR, -(EO) x , - (PO) x , - NH 2 , and- NO 2 wherein R is a C 1 to C 10 alkyl group.
- Additional exemplary organic acids include oxalic acid, phthlaic acid, sebacic acid, adipic acid, citric acid, maleic acid, and modified forms thereof containing side groups including halogen, - OH, - R, - OR, -(EO) x , - (PO) x , - NH 2 , and- NO 2 wherein R is a C 1 to C 10 alkyl group. It should be understood that the subscript X refers to repeating units. Additional exemplary organic acids include fatty acids such as aliphatic fatty acids and aromatic fatty acids.
- Exemplary aliphatic fatty acids include oleic acid, palmitic acid, stearic acid, and C 3 -C 26 fatty acids that may be saturated or unsaturated, and sulfonated forms of fatty acids.
- An exemplary aromatic fatty acid includes phenylstearic acid. Additional acids that can be used include peroxycarboxylic acid such as peroxyacetic acid, and phthalimidopercarboxylic acids. Additional acidic pH adjusting agents include carbon dioxide and ozone.
- the pH adjusting agent is an acidifying agent, more particularly an organic acid, and especially citric acid.
- the pH adjusting agent is an acidifying agent, more particularly an organic acid, and especially citric acid and the source of alkalinity is an amine, more particularly triethylamine (TEA).
- an acidifying agent more particularly an organic acid
- citric acid and the source of alkalinity is an amine, more particularly triethylamine (TEA).
- TAA triethylamine
- the pH can be adjusted by adding the pH adjusting agent and/or by allowing the pH adjusting agent to cause a pH shift.
- the pH adjusting agent can be formed in situ by reaction and/or the pH adjusting agent can be coated and, once the coating is degraded, the pH adjusting agent can become exposed to the liquid concentrate cleaning composition.
- One or more preservatives also known as antimicrobial agents or biocides are typically included in the non-enzymatic liquid concentrate cleaning compositions herein at a total preservative level of from 0.01 weight % to 2 weight %.
- preservatives for use include: phenoxyethanol, and 1,2-Benzisothiazol-3(2H)-on (BIT) commercially available within the Nuosept® product range from Ashland.
- BIT 1,2-Benzisothiazol-3(2H)-on
- non-enzymatic liquid concentrate cleaning compositions include one or more preservatives at a total level of from 0.05 weight % to 1.0 weight %, from 0.1 weight % to 1 weight %.
- Dyes may be included to alter the appearance of the composition, as for example, Patent Blue V, 4-[4,4',-Bis-diethylamino- ⁇ -hydroxy-benzhydryl]-6-hydroxy-benzol-1,3-disulfoacid, also known as iso-sulphan blue available from Sigma-Aldrich, Direct Blue 86 (Miles), Fastusol Blue (Mobay Chemical Corp.), Acid Orange 7 (American Cyanamid), Basic Violet 10 (Sandoz), Acid Yellow 23 (GAF), Acid Yellow 17 (Sigma Chemical), Sap Green (Keyston Analine and Chemical), Metanil Yellow (Keystone Analine and Chemical), Acid Blue 9 (Hilton Davis), Sandolan Blue/ Acid Blue 182 (Sandoz), Hisol Fast Red (Capitol Color and Chemical), Fluorescein (Capitol Color and Chemical), Acid Green 25 (Ciba-Geigy), and the like.
- Patent Blue V 4-[4,4',-Bis-diethylamino- ⁇ -hydroxy
- Fragrances or perfumes that may be included in the compositions include, for example, terpenoids such as citronellol, aldehydes such as amyl cinnamaldehyde, a jasmine such as CIS-jasmine or jasmal, vanillin, and the like.
- the total level at which one or more dyes, or one or more perfumes or odorants may be independently included is from about 0.0001 to about 0.2 weight %.
- novel non-enzymatic cleaning compositions are suitable for cleaning a wide variety of articles including: surgical, medical or dental instruments; surgical probes including flexible endoscopes; ware including food plates or platters, food containers or cutlery; beverage containers including bottles, glasses, jugs, cups or mugs.
- Such cleaning can be carried out manually or automatically in accordance with the methods detailed herein wherein the selection of the cleaning route will be dependent upon the nature of the article to be cleansed.
- surgical, medical or dental instruments surgical probes including flexible endoscopes are preferably cleansed using manual methods.
- cleaning solutions comprising the novel non-enzymatic compositions herein are substantially non-corrosive to metals such as stainless steel, anodized aluminium, aluminium, copper and brass which are often at risk of damages when soaked in previously available alkaline cleaning products.
- the cleaning solution provided by the invention can be used for any suitable purpose.
- the senor is employed as a soak cleaner for medical and surgical instruments, dental hand piece, and the like, for both human and veterinary practice.
- a soak cleaner When used as a soak cleaner, it is applied before the instruments are disinfected. It can also be readily used as a concentrate to be added to ultrasonic baths and to automatic washers, for cleaning more elaborate medical equipment.
- the cleaning and detergent solutions comprising an aqueous solution of the non-enzymatic cleaning compositions as defined herein are readily employed at elevated temperatures, as high as about 45 0 C.
- Foreign matter to be cleaned or removed includes, for example, biological substances, e.g., tissue and blood.
- Foreign matter also includes other materials such as lubricant, diagnostic and therapeutic compositions, materials for pathology testing, medical or veterinary research, and the like, remaining on instruments after these are employed for their intended use.
- Foreign matter also includes pathogens including bacteria, viruses, and prions.
- instrument as used herein is intended to be defined broadly, to include any articles, items, objects, implements or devices for which the gentle removal of organic or biological substances, such as protein, fats, carbohydrates and similar material is desirable.
- instruments are implements employed in patient or client contact (human or veterinary) during the practice of surgery, medicine, dentistry, podiatry, pathology for e.g., therapeutic, diagnostic and/ or research purposes.
- Examples include, surgical instruments, e.g., scalpels, probes, clamps, etc., endoscopes, operating room or dental hand-pieces, ventilation tubes, and the like.
- Surgical instruments and equipment inevitably pick up amounts of bio-burden on them after being employed in operations on humans or animals.
- Surgical instruments include for example rigid and flexible probes and scopes, and specifically including flexible endoscopes, laparoscopic instruments, trays and anything that gets soiled with body fluids which result in them having varying amounts of bio-burden on them after being so used.
- novel non-enzymatic compositions as detailed herein also include miscellaneous other instruments and/or implements employed in cosmetic and beauty applications. These applications include hair cutting, nail care, body art, skin piercing, collection of body fluids, e.g., blood, and blood separation and fractionation equipment, and similar such applications, that are too numerous to mention.
- the novel non-enzymatic compositions are also contemplated for use in cleaning implements and items employed in the food processing and pharmaceutical industries.
- a use solution of a test composition is prepared by diluting the composition with water at room temperature (RT).
- RT room temperature
- concentration of the test composition in water can be varied according to the nature of the particular assessment to be undertaken.
- use solutions having test composition aqueous concentration levels of 10%, 5%, 1%, 0.5%, 0.3% or 0.2% can be tested using in the methods detailed herein.
- the purpose of this test is to enable to measurement of the efficiency of blood cleaning performance of different cleaning compositions.
- contact times of 5 minutes and 2 minutes have been used, although shorter or longer contact time periods may be used depending upon the nature of the substrate (metal coupon) or soil (blood etc) being tested.
- contact times of 5 minutes and 2 minutes have been used, although shorter or longer contact time periods may be used depending upon the nature of the substrate (metal coupon) or soil (blood etc) being tested.
- a batch of coupons is prepared as follows: Stainless steel coupons (5x5x0.1 cm) are cleaned and degreased with acetone for preparation. The coupons were dried prior to soiling by placing them on a bench for 30min. Typically 3 coupons were tested for each concentration of a particular formula. The combined weight of all the coupons is then measured and recorded. 0.2 g of reactivated sheep blood (commercially available from for example from Fiebig-Nährstofftechnik) is weighed out and delivered onto each coupon and spread across the coupon surface. For ease of handling and to avoid contamination of the test area it can be useful to leave a small frame, typically around 3mm around the outside of each coupon thereby providing a soil-free (clean) handling area. The soiled coupons are then dried in a drying cabinet for 1 hour at 45°C. After cooling down to room temperature the combined weight of all the dried, soiled coupons is measured and recorded.
- 400ml of an aqueous use solution of a test Composition at the desired aqueous concentration level of: 0.2%, 0.5% and/or 1% is prepared in the required water (de-ionised, tap / 14°C dH DE, or Hard / 23°C dH DE as detailed hereinbefore, but at a temperature of 20°C to 23°C and added into a standard 500ml beaker.
- the test coupons (one coupon per beaker, 3 coupons per formula) were immersed in the test solution and left for 5 minutes without agitation, in an environment where the external temperature is from 20°C to 23°C RT. At the end of this 5 minute test solution contact time, the coupons were removed and immersed in clean water for rinsing. Then the test coupons were dried at ambient temperature (20 to 23°C) overnight.
- the level of soil removal is evaluated both visually and gravimetrically.
- the total starting weight of the coupons with dried blood i.e. the pre-immersion weight
- the total weight of the clean coupons i.e. the pre-soiling weight
- the total weight of the cleaned coupons i.e. the post-immersion and drying weight
- the weight of the clean coupons i.e. the pre-soiling weight
- a use solution of a composition to be tested in water is prepared at room temperature (RT).
- RT room temperature
- concentration of test composition in water can be varied according to the nature of the particular assessment to be undertaken.
- use solutions having test composition aqueous concentration levels of 10%, 5%, 1% or 0.5% are tested using this method.
- a sample of the use solution to be tested (100 ml) is poured, placed or otherwise filled into a 250 ml measuring cylinder (height: 30.5cm, width: 3.7cm).
- the cylinder is closed with a polyethylene (PE) plug. Any suitable PE plug which effectively seals the cylinder and prevents or substantially limits the escape of test solution can be used.
- the so-closed cylinder is then tilted 20 times from a substantially upright position to a substantially upended / upside down position.
- the resultant foam height in the cylinder is measured as soon as practicably possible following the removal of the plug. This measurement provides a baseline, 0 minute foam height.
- the foam height is then measured at further pre-defined time points, of 1 and 5 minutes thereafter.
- the foam height in the measuring cylinder is measured with a ruler and documented in millimetres (mm).
- the measuring cylinder is cleaned and rinsed with ethanol for degreasing; followed by rinsing with demineralized water.
- the cloud point is the temperature where a liquid product becomes cloudy.
- a use solution is prepared and an assessment of its clarity is made using the naked eye.
- a use solution is a solution of a composition to be tested in water.
- the concentration of the use solution of a test composition can be varied according to the nature of the particular assessment to be undertaken.
- aqueous concentration levels of 10%, 5%, 1%, 0.5%, 0.3% or 0.2% can be tested using this method.
- the relative stability of test compositions in different water conditions can be measured by recording the cloud points of use solutions prepared from water of different degrees of ( 0 dH).
- the use solution at the desired concentration level is filled into a 150 ml beaker at room temperature (RT).
- RT room temperature
- the temperature is raised slowly and monitored with a thermometer.
- the means for increasing the temperature includes any suitable graduated heating method which can be pre-set or pre-programmed.
- the temperature at which the test composition use solution shows the first signs of cloudiness, as observed by the naked eye, during heating is documented. The heating is stopped and the solution is allowed to cool naturally. Both the solution and the temperature are observed during this cooling period. The temperature is documented when the solution first becomes clear again.
- cloud points are determined with an accuracy of 0.5 0 C. Typically the test is repeated at least twice to ensure consistency of results.
- test solutions of the compositions to be tested at the desired concentration level are prepared as indicated hereinbefore.
- the test solutions can be prepared in de-ionised (DI) or tap water as desired. Tap water is a more likely real-life scenario, whilst DI water provides a worst-case, stress test scenario.
- DI water is a more likely real-life scenario, whilst DI water provides a worst-case, stress test scenario.
- the metal materials to be assessed for compatibility with the test composition solutions are provided as metal plates, such as for example Steel or Aluminium plates. Whilst the size of the plates can vary it is important that the same size and material of plates are used for each test solution within any group of tests. Typically plates of (12cm by 6cm by 0.1cm) are used.
- each plate is measured in its dry state prior to testing, and again post-immersion.
- the testing is carried out at room temperature and each test plate is fully immersed an in-use solution of 500ml of the test composition at the desired aqueous concentration, for example 0.5%, in a suitable container, such as for example in a beaker (600ml).
- test plates After one week each of the test plates was rinsed off with DI water, dried and the weight was re-measured. On the following day the plates were immersed again (in freshly prepared test solutions) and the procedure was repeated twice more.
- the results obtained from this test can be provided either as raw data set or as an average data set of the average % weight loss.
- compositions E, F, G which contained varying levels of at least PL1740 as a nonionic surfactant and 10% GLDA as a super-complexing agent could provide desirable foam heights in combination with clarity across conditions and retain elevated (alkaline) pH.
- the foam height, clarity and pH retention of Compositions E, F, G were compared to an enzyme containing formulation, Sekusept Multienzyme, Composition J, and two further comparator formulations, Compositions H and I based on alternative nonionic surfactants at a total level of 4%, and each containing GLDA at 10%, and again formulated at elevated pH.
- compositions E to J as well as physical properties (pH and visual appearance) of formulations E to I and multi-enzyme formulation J is also provided in Table 1.
- the relative composition of the components in formulations E to I are shown as weight percentages, wt. %, out of a total composition level of 100.00.
- Table 1 additionally provides data relating to foam height, as well as clarity and pH data for each formulation, at the point of manufacture, after 24 hours (at room temperature), and in 1% use solutions in de-ionised water and in tap water (14°dH DE).
- test Composition E which contained PL1740-alone was clear at the point of manufacture but became cloudy after 24 hours.
- Test Compositions F and G provided desirable clarity under all conditions and demonstrated improved foam height results both initially and after 1 minute in 1% solutions in both de-ionised and tap water.
- test Compositions F and G provide desirable clarity under all conditions.
- Table 2 additionally provides information as to the method of preparation of test Compositions K and L.
- TABLE 2 Component Trade Name K Order L Order Solvent Aqua purificata 72.37 1 78.37 1 Nonionic surfactant Pluronic RPE 1740 6.00 2 - - Nonionic Surfactant Synperonic T/304 - - 10.00 2 Hydrotrope Na cumene sulphonate 10.00 3 - - Super-complexing agent Trilon M Liquid 5.00 4 5.00 3 Alkalinity Triethanolamine 99% 5.00 5 5.00 4 Corrosion Inhibitor Hordaphos MDAH 0.95 6 0.95 5 Preservative Protectol PE 0.5 7 Preservative Nuosept BM 22 - - 0.5 6 Dye Patent Blue 85 E 131 0.0015 8 0.0015 7 pH adjust Citric acid monohydrate 0.18 9 0.18 8 TOTAL 100.00 100.00 100.00 100.00 pH 9.5 9.5 9.5
- Table 3 additionally provides information as to the method of preparation of test Compositions M, N and O.
- TABLE 3 Component Trade Name M N O Order Solvent Aqua purificata 75.30 77.21 68.37 1
- Super-complexing agent Trilon M Liquid 5.00 2.50 10.00 3
- Alkalinity Triethanolamine 99% 15.00 15.00 15.00 4 pH adjust Citric acid monohydrate 1.50 2.09 3.48 5
- Preservative Protectol PE 0.5 - - 6
- Preservative Nuosept BM 22 - 0.20 0.20 6 TOTAL 100.00 100.00 100.00 pH 9.5 9.5 9.5
- compositions P, Q, R, S, T were prepared which included combination of a super complexing agent, MGDA with TEA as the source of alkalinity (at the same level in each formulation) in combination with either T304 or PL1740 (nonionics), and either Hordaphos MDAH or MDGB (corrosion inhibitors).
- MGDA super complexing agent
- TEA super complexing agent
- T304 or PL1740 nonionics
- Hordaphos MDAH or MDGB corrosion inhibitors
- Formulation Q was prepared at a below target pH level (pH 8.62), and was found to be turbid on initial formulation, this confirms the value of maintaining the target pH level of pH 9.5 or above.
- compositions according to the invention Compositions R, S and T provide clear compositions with acceptable foam performance (although not as low as for P or Q) in the absence of propylene glycol.
- Test formulations Compositions U and V, were prepared which were similar to compositions P and Q in Table 4, but with different water contents and without propylene glycol. The purpose of this experiment was to confirm that desirable clarity and foam performance could be provided by PL1740 nonionic formulations without PG.
- compositions U and V are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 5.
- Table 5 additionally provides information as to the order of addition for preparation as well as formulation W, which was tested versus compositions Ua for cleaning efficacy as discussed hereinafter.
- Composition L2 which corresponds to Composition L (see Table 2), but with a lower level of MDAH was prepared.
- the purpose of this experiment was to determine the impact of MDAH level and whether use of a pre-mix of water / TEA / MDAH impacted on the initial formulation stability.
- Formulation L2 did achieve a target finished (adjusted) pH level of 9.5.
- compositions L and L2 are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 6.
- Table 6 additionally provides information as to the order of addition for preparation as well as pH and clarity data. For the avoidance of doubt the data for Composition L is extracted from Table 2 hereinbefore.
- compositions in accordance with the invention were tested versus a number of commercially available enzyme-containing compositions. These tests confirmed the desirable performance levels of present compositions versus these commercial compositions at both 2 and 5 minute soak times. A number of these results are illustrated and discussed hereinafter.
- Test solutions of compositions K and L were prepared and diluted solutions thereof at 0.5%, in deionised (DI) water were assessed for cleaning efficacy against blood soil for 2 minutes soak time versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulations Endozyme AW Plus (from Ruhof), and a commercial multi-enzymatic comparator formulation Aniosyme DD1 (from Anios).
- DI deionised
- the testing was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition.
- the plates were weighed before soiling, after soiling (with blood) and after cleaning.
- the percentage removal was calculated for each, as well as the average percentage removal.
- Test product K 0.5% 15.5387 15.5730 15.5396 97.3761 2 Min DI-Water 15.5884 15.6274 15.5904 94.8718 15.7839 15.8330 15.7866 94.5010 Test product L, 0.5% 15.5692 15.6161 15.5700 98.2942 2 Min DI-Water 15.5263 15.5573 15.5272 97.0968 15.7335 15.7667 15.7345 96.9880 Aniosyme DD1, 0.5% 15.5134 15.5460 15.5149 95.3988 2 Min DI-Water 15.5983 15.6341 15.6044 82.9609 15.8322 15.8718 15.8348 93.4343 Endozyme AW Plus, 0.5% 15.7974 15.8342 15.8033 83.9674 2 Min DI-Water 15.4351 15.4783 15.4373 94.9074 15.4866 15.5330 15.4905 91.5948 % blood removed Test product K, 0.5%, 2 Min DI water 95.5830 Test product L, 0.5%,
- compositions K and L of the present invention deliver superior cleaning performance in terms of percentage blood removal after 2 minutes versus enzymatic comparator compositions. These results are very surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
- compositions of the invention have been demonstrated to deliver improved soil removal after 2 minutes versus comparator compositions.
- compositions K and L of the present invention deliver superior cleaning performance in terms of percentage blood removal after 2 minutes versus both enzymatic comparator compositions. These results are very surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
- compositions of the invention have been demonstrated to deliver improved soil removal after 2 minutes versus comparator compositions.
- empty plate plate blood after cleaning % removal Test product K, 0.5% 15.5259 15.5599 15.5292 90.2941 5 Min DI-Water 15.4183 15.4601 15.4205 94.7368 15.7329 15.7768 15.7340 97.4943
- Test product L 0.5% 15.5685 15.605 15.5783 73.1507 5 Min DI-Water 15.7972 15.8376 15.8026 86.6337 15.8296 15.8743 15.8331 92.1700 Aniosyme DD1, 0.5% 15.5384 15.5738 15.5403 94.6328 5 Min DI-Water 15.5978 15.6415 15.5997 95.6522 15.8317 15.8805 15.8351 93.0328 Endozyme AW Plus, 0.5% 15.7838 15.8422 15.7854 97.2603 5 Min DI-Water 15.4397 15.4846 15.4407 97.7728 15.5126 15.5470 15.5145 94.4767 % blood
- Test solutions of compositions A1, A2, A3 and A1-a were prepared and diluted solutions thereof at 0.5%, 1%, in deionised (DI) water were assessed for cleaning efficacy versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulation Sekusept from Ecolab.
- DI deionised
- compositions of the present invention deliver cleaning performance at similar levels to that of the comparator enzyme containing composition. These results are surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
- % blood removed Enzymatic Cleaner 2 Min DI-H 2 O 85.9886 A1, 2 Min DI-H 2 O 83.3464 A2, 2 Min DI-H 2 O 86.4036 A3, 2 Min DI-H 2 O 89.5045 A1-a, 2 Min DI-H 2 O 86.5046
- Test solutions of compositions B1, B2, B3 and B1-a were prepared and diluted solutions thereof at 0.5%, 1%, in DI water were assessed for cleaning efficacy versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulation (Sekusept) and a non-enzymatic commercially available formulation Aniosyme DD1.
- the test was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition. In each instance the plates were weighed before soiling, after soiling (with blood) and after cleaning. The percentage removal was calculated for each.
- compositions of the present invention deliver cleaning performance at similar levels to that of the comparator enzyme containing composition, and that composition B2 delivers improved cleaning. All of the test compositions and the enzyme comparator formulation outperformed the non-enzymatic comparator formulation. These results are surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
- compositions A1 to B1-a as illustrated in Table 8 and also for a comparator enzymatic composition (Sekusept Multienzyme). The method was carried out in accordance with the procedure detailed hereinbefore, and in each test case, the plates were immersed an in-use solution of the test composition at 0,5% aqueous concentration in deionised (DI) water, in a beaker (600ml).
- DI deionised
- compositions K and L were prepared from compositions K and L (as illustrated in Table 2). The method was carried out in accordance with the procedure detailed hereinbefore, and in each test case, the Anodized Aluminium plates were immersed an in-use solution of the test composition at 0.5% aqueous concentration in TAP water (water hardness 14 °dH), in a beaker (600ml). The results for Composition K are shown in Table 9 and the results for Composition L are shown in Table 10.
- test piece Weight loss (%) 1 week 2 weeks 3 weeks Red Plate 0,0051 -0,0028 -0,0020 Blue Plate 0,0057 -0,0033 -0,0005 TABLE 10 test piece Weight loss (%) 1 week 2 weeks 3 weeks Red Plate 0,0065 -0,0028 -0,0008 Blue Plate 0,0057 -0,0027 -0,0016
- compositions K and L show negligible weight losses in these stress test conditions.
- Compositions of the invention have been demonstrated to show highly desirable material compatibility when tested with both red and blue Anodized Aluminum.
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Description
- The disclosure pertains to non-enzymatic compositions useful for cleaning surgical, medical and dental instruments and flexible endoscopes prior to reuse. In particular, the disclosure pertains to liquid concentrate non-enzymatic compositions useful for cleaning such instruments prior to a disinfection process, as well as to methods for use of the non-enzymatic compositions in such treatments.
- Effective cleaning, sterilization and disinfection of articles are of the upmost importance in many industries, such as healthcare, the food industry, etc. For example, reusable medical instruments, such as surgical instruments or probes, including flexible endoscopes, are typically contaminated with blood and other body matter and potentially with infectious microorganisms during use and require cleaning and sterilization / disinfection after each use to ensure that the risks of cross infection from patient-to-patient as well as from patient-to-health care personnel are minimized.
- Surgical instruments including flexible endoscopes are normally pre-cleaned prior to automatic cleaning and disinfection. Manual pre-cleaning with the help of brushing serves to remove macroscopic soil rests and to free any present clogging sites which may not be successfully cleaned in the machine.
- A typical cycle for automatic cleaning of medical instruments consists of a number of consecutive stages: pre-wash, wash, rinses (usually two) and drying. The pre-wash stage is primarily used to dissolve blood on the instruments and may be run with a suitable wash solution. The wash part of the cycle is run with a wash solution which typically contains or more surfactants. Both the pre-wash and wash solutions may additionally contain one or more enzymes. Wash time, water temperature, surfactant selection, and wash solution concentration levels can vary depending upon the particular nature of the instrument and/or soil to be cleaned therefrom. The purpose of the rinse stage(s) is primarily to remove soil dissolved in the pre-wash and /or wash stage(s) as well as to remove any remaining surfactant-containing wash solution.
- Medical instruments that are thermally stable, such as scissors, knives or scalpels, may be sterilized by processing at a high temperature.
- However, many articles including surgical, medical or dental instruments or probes such as flexible endoscopes are temperature sensitive, particularly at relatively high temperatures, and therefore must be cleaned and disinfected at lower temperatures either manually or in a machine.
- The process of cleaning, sterilizing and disinfecting instruments which are temperature sensitive is especially complicated where blood or other matter has been allowed to dry on the instruments. Body fluids, such as blood, lipids and synovial fluids from joints can adhere to the instruments during use in a surgical procedure, and as such fluids dry, the adhesion becomes stronger and the adhered body-fluid based matter becomes harder to dissolve using ordinary cleaning methods. Blood in particular becomes more difficult to remove once it has dried. Therefore, any cleaning composition to be used in these situations must be able to clean a range of body fluids effectively from a variety of different substrate surfaces such as are found on such as surgical instruments or probes, including flexible endoscopes.
- In the past it was thought that there was a risk that the instruments having strongly adhered matter could remain soiled after cleaning with conventional detergent-based cleaning compositions. Such soil retention would pose a health risk if the instrument was re-used immediately following cleaning. However, an increased risk is potentially posed if an instrument having retained soil is stored for a period following cleaning because during the storage period bacterial growth is possible, which could affect not only the soiled instrument, but also its surrounding environment. To obviate the risks associated with ineffective removal of adhered body matter, improved cleansing compositions which included one or more enzymes were developed in order to break-down both the chemical structure of the adhered body-fluid based matter, as well as the physical/adhesive bond between matter and the instrument via hydrolysis. Compositions containing one or more enzymes are disclosed in
WO 2009/095827A1 are able to deliver effective cleaning at neutral (6.5) pH levels. - Whilst the cleaning power of enzymes is undoubted, their increased use has led to concerns in relation to potential health issues, and issues associated with the spread of enzymes in reprocessing areas. These concerns are of sufficient magnitude that some countries are considering whether enzymes should be incorporated in cleaning compositions in the future. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter at levels consistent with those provided by current enzyme-including cleaning compositions.
- Currently cleaning compositions which do not contain one or more enzymes are generally formulated at alkaline pH levels. The use of extreme pH levels in cleaning compositions, whether highly acidic or highly alkaline can introduce additional contamination risks in the medical, surgical and dental fields due to material incompatibility effects.
-
US 2014/311529 discloses a detergent composition for endoscope washers, including a non-ionic surfactant represented by the formula R-O-[(EO)m/(PO)n]-H, a branched-chain fatty acid having not less than 6 and not more than 10 carbon atoms or a salt thereof, a defoaming agent and water. -
WO 2006/086875 discloses a method for cleaning dental and medical instruments, in which a cleaning solution including a low-residue corrosion inhibitor is used not only in a wash stage of the cleaning cycle, but also in at least one subsequent cycle. The cleaning solution has a neutral to alkaline pH and comprises a low foaming surfactant and a corrosion inhibitor selected from the group of C4 - C16 alkyl pyrrolidones and C1 - C18 alkylamines. - Typical non-enzyme containing cleaning compositions as are known in the art are aggressive and often use moderately or even highly alkaline conditions to provide a high cleaning performance.
- As will be readily appreciated many articles including surgical, medical or dental instruments or probes such as flexible endoscopes which require routine re-cleaning prior to re-use comprise metallic components, and even moderately alkaline cleaning compositions such are typical in the art are often highly aggressive towards metals and metal alloys, such as steel, stainless steel, copper, zinc, brass, aluminum, and anodized aluminum, for example. However for aluminum and zinc in particular, exposure to moderate to highly alkaline pH conditions inhibits passivation.
- Given the requirement for repeated use, cleaning and re-use of such articles, over time the impact of cleaning using aggressive, alkaline formulations increases the risk of corrosion of the metallic surfaces of such articles, either in whole or in part i.e. localized corrosion concentration such as pitting or cracking. Whilst an impact of metal corrosion is degradation of intrinsic properties such as strength, with associated risk of breakage orfracture, a particular risk for articles for use in the surgical, medical and dental fields is the risk that the surface becomes less impermeable to body fluids. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter from metal surfaces and which have desirable material compatibility.
- An indication that the surface properties of metal articles, or metal containing articles have been compromised via repeated cleaning with aggressive, alkaline formulations is discoloration of the articles, either in whole or in part. A metal surface which has been compromised, via corrosion or other degradation processes may include cracks or pits which are potential additional sites for bacterial colonies to be established. Once corroded, such articles may require repair to re-establish the integrity of the metal surface, such as via coating processes, or even replacement of the entire instrument. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter from metal surfaces and which have reduced risk of post-cleaning soil retention.
- During the cleaning process current highly alkaline non-enzyme cleaning compositions can tend to generate levels of foam which either obscure the wash solution in this the articles are immersed, or which cling to the article being cleansed when removed from the solution thereby leading to a longer and less efficient cleaning process. When utilized in manual cleaning of articles, some of these compositions can also provide cloudy or milky solutions in which it is difficult to clearly see the article to be cleansed when immersed in said solution, and therefore to effectively cleanse any adhered soil thereon. Therefore, there is a need for new non-enzyme based cleaning compositions which are capable of removing strongly adhered matter from metal surfaces at neutral or mildly alkaline pH levels and which provide clearer wash solutions and/or reduced levels of foaming during the cleaning process.
- Novel non-enzymatic cleaning compositions are provided that are particularly suitable for manual cleaning of articles, and in particular surgical, medical or dental instruments including probes and flexible endoscopes.
- The novel liquid concentrate non-enzymatic cleaning compositions provide desirable cleaning performance levels in comparison to neutral enzyme-including compositions. The novel liquid concentrate non-enzymatic cleaning compositions provide desirable cleaning performance levels across a broad range of in use concentrations in comparison to neutral enzyme-including compositions.
- The novel liquid concentrate non-enzymatic cleaning compositions have improved material compatibility in comparison to conventional highly alkaline non-enzyme containing compositions.
- The novel liquid concentrate non-enzymatic cleaning compositions: are low or no foaming at in use concentration levels; provide low foaming in use (dilute) solutions across a broad range of concentration levels, from 0.2% to 2.0%; provide a cleaning or wash solution which at in use concentration levels is not cloudy at temperatures of up to and including 45°C; are stable across a range of storage conditions in concentrated (undiluted) form; are stable across a range of hardness conditions at in aqueous solutions at in use concentration levels, such as for example up to and including 23 degrees of hardness, on the German hardness scale (0dH DE); demonstrate good material compatibility.
- The present liquid concentrate non-enzymatic cleaning compositions are defined in the appended claims.
- The low foaming surfactant system comprising at least one nonionic surfactant may comprise from about 1 to about 15 weight % of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer.
- The at least one complexing agent may comprise one or more super-complexing agents and optionally one or more complexing agents as defined hereinafter. In one aspect the at least one complexing agent comprises one or more small molecule organic super-complexing agents and especially methylglycine diacetic acid (MGDA) and acid or alkali metal salts thereof.
- The at least one source of alkalinity may comprise one or more amines. In one aspect the at least one source of alkalinity comprises an alkanolamine independently selected from: triethanolamine (TEA); TEA 99%; monoethanolamine (MEA); diethanolamine (DEA); and combinations or mixtures thereof.
- The moderately alkaline pH level may comprise a pH in the range of from 7 to 12; from 8 to 10; from 8.5 to 9.5, about 9.5.
- The at least one anti-corrosion agent may comprise one or more phosphoric acid esters, and/or one or more phosphonic acid esters. In one aspect the at least one corrosion inhibitor is a phosphate ester independently selected from phosphoric acid, 2-ethylhexyl ester, commercially available from Clariant as Hordaphos® MDAH, or phosphoric acid, mixed esters with butyl alcohol and ethylene glycol, commercially available as Hordaphos® MDGB.
- A non-enzymatic cleaning composition is provided that can comprise a low foaming surfactant system comprising at least one nonionic surfactant, at least one complexing agent, optionally at least one anti-corrosion agent, at least one source of alkali and a moderately alkaline pH level.
- Typically, the cleaning composition has a pH of about 9.5.
- In some aspects, the low foaming surfactant system comprising at least one nonionic surfactant is present in the cleaning composition in an amount ranging from about 0.1 to 15.0 weight %, the at least one complexing agent is present in an amount ranging from about 0.1 to 10.0 weight %, the at least one source of alkalinity is present in an amount ranging from about 0.1 to 10.0 weight %, optionally, the at least one anti-corrosion agent is present in an amount ranging from about 0 to 5 weight %, and the cleaning composition has a pH of about 9.5.
- In certain aspects, the low foaming surfactant system comprising at least one nonionic surfactant is present in the cleaning composition in an amount ranging from about 2.0 to 10.0 weight % the at least one complexing agent is present in an amount ranging from about 2.0 to 8.0 weight %, the at least one source of alkalinity is present in an amount ranging from about 3.0 to 8.0 weight % and the cleaning composition has a pH of: from 8 to 10; from 8.5 to 9.5; or about 9.5.
- According to one aspect the non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- (a) 0.1 to 15.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;
- (b) 0.1 to 10.0 weight % of at least one complexing agent;
- (c) 0.1 to 10.0 weight % of at least one source of alkalinity;
- (d) 0 to 5.0 weight % of at least one anti-corrosion agent;
- (d) 60 to 99.7 weight % of an aqueous solvent
- According to a further aspect the non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- (a) 0.1 to 15.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;
- (b) 0.1 to 5.0 weight % of at least one complexing agent;
- (c) 0.1 to 10.0 weight % of at least one source of alkalinity;
- (d) 0 to 5.0 weight % of at least one anti-corrosion agent;
- (d) 65 to 99.7 weight % of an aqueous solvent
- According to a yet further aspect the non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- (a) 0.1 to 10.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;
- (b) 0.1 to 5.0 weight % of at least one complexing agent;
- (c) 0.1 to 10.0 weight % of at least one source of alkalinity;
- (d) 0.1 to 5.0 weight % of at least one anti-corrosion agent;
- (d) 70 to 99.6 weight % of an aqueous solvent
- Methods of cleaning articles using the novel non-enzymatic cleaning compositions for the delivery of effective cleaning whilst limiting alkaline-pH associated corrosion or degradation of the metallic surfaces of the articles by the cleaning composition are also provided. Typically, the articles to be cleaned are metal articles and the step of cleaning the article with the novel non-enzymatic cleaning composition is carried out manually. The methods can include the steps of providing an article to be cleaned and directly applying an effective amount of the novel non-enzymatic cleaning composition to the article, either in diluted form or as a concentrated solution, and cleaning of the article therewith, followed by at least one rinsing step, and optionally at least one further cleaning and washing cycle. The methods can include the steps of providing an article to be cleaned, providing an effective amount of the novel non-enzymatic cleaning composition in an aqueous solution and cleaning the article with/in the dilute aqueous solution containing the novel non-enzymatic cleaning composition.
- Typically, the novel non-enzymatic cleaning composition is at least partially diluted to form a concentrated or a dilute aqueous solution prior to use.
- In some aspects, the step of cleaning the article with the novel non-enzymatic cleaning composition is carried out automatically.
- An effective amount of the novel non-enzymatic cleaning composition is preferably such that desirable foam levels, solution clarity (turbidity), cleaning efficacy (particularly cleaning of blood and/or blood-based soils are provided using the composition after dilution to provide an aqueous solution of the composition prior to use.
- In a further aspect an effective amount of the novel non-enzymatic cleaning composition is preferably such that desirable foam levels, solution clarity (turbidity), cleaning efficacy (blood / blood-based soil cleaning), and material compatibility (anti-corrosive effects) are provided using the composition after dilution to provide an aqueous solution of the composition prior to use.
- For example, in an embodiment of the invention, an effective amount of the novel non-enzymatic cleaning composition is such that the amount of the low foam surfactant system comprising at least one nonionic surfactant ranges from about 0.1 to 15.0 weight %, the amount of the at least one complexing agent is present in an amount ranging from about 0.1 to 10.0 weight %, and the amount of the at least one source of alkalinity is present in an amount ranging from about 0.1 to 10.0 weight % and the cleaning composition is then diluted with water to between 10% original concentration to 0.1% original concentration.
- For example, for use in cleaning surgical, medical and dental instruments and flexible endoscopes as defined herein prior to their re-use, the concentrated non-enzymatic cleaning composition may be diluted with a suitable aqueous solvent to 10%, 5%, 2%, 1%, 0.5% or preferably 0.2% of the original composition concentration prior to use i.e. a 10% aqueous solution of the composition. The choice of dilution for any particular in-use aqueous cleaning solution will be dependent upon the level or soil, the type of soil, the time the soil has been left on the surface, as well as the hardness of the water used to dilute the composition.
- For the avoidance of doubt, and unless specified to the contrary, where the relative amounts of any particular component in the compositions herein are expressed in terms of % weight this means the amount of the component relative to the total amount of the composition. For example, 6% of a source of alkalinity in a cleaning composition herein means that 100g (100%) of the composition contains 6g (6%) of said source of alkalinity.
- The foregoing has outlined rather broadly the features and technical advantages of the present disclosure in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the disclosure will be described hereinafter that form the subject of the claims. It should be appreciated by those skilled in the art that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other embodiments for carrying out the same purposes of the present disclosure. It should also be realized by those skilled in the art that such equivalent embodiments do not depart from the spirit or scope of the disclosure as set forth in the appended claims.
- The present disclosure provides non-enzymatic compositions useful for cleaning surgical, medical and dental instruments and flexible endoscopes prior to reuse. In particular, the disclosure provides liquid concentrate non-enzymatic compositions useful for cleaning such instruments prior to disinfection, as well as to methods for use of the non-enzymatic compositions in such cleaning treatments.
- For the avoidance of doubt, the liquid concentrate compositions herein may be applied directly to an article to be cleaned without dilution, or may be applied as concentrated solutions to an article to be cleaned, or may be diluted to form aqueous in use solutions into which articles to be cleaned may be immersed and cleaned.
- The terms cleaning as used herein in terms of liquid concentrate, or in-use solutions thereof, means suitable for use in cleaning wherein cleaning as defined herein means the removal of soils, marks, stains, dirt or other material from the surface of an item.
- The present compositions are formulated to have at least a moderately alkaline pH level both on manufacture of a finished liquid concentrate, and when in-use as a diluted solution. A moderately alkaline pH level as defined herein is a pH of from about pH 7 to about pH 10.5. According to an aspect the non-enzymatic compositions herein have a finished pH of: at least 7.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and about 9.5.
- Accordingly non-enzymatic cleaning compositions are provided which additionally are formulated to have a finished pH of: at least 7.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and about 9.5.
- For the avoidance of doubt, the finished pH of a liquid concentrate composition as detailed herein is the final pH of the composition following pH adjustment with acid or base as necessary to bring the pH into line with the desired levels of from about 7.5 to about 10.5, and preferably about pH 9.5.
- As will be readily appreciated the pH of an in-use solution where the liquid concentrate has been diluted with water will substantially correspond to the pH of the original liquid concentrate and ideally be within 0.1 to 1, or 0.5 to 1 pH unit of the finished pH level. Any suitable form of water may be used to provide an in-use solution, de-ionized (DI), or tap water. Typically tap water will be used, in which case the water will have a defined hardness level (the degree of hardness).
- The cleaning performance of certain aspects is particularly effective in the removal of dried body fluids, and especially of dried blood.
- The present compositions provide low, or no foaming use solutions at temperatures of up to and including 45°C. A low foaming or no foaming use solution as defined herein is a solution having an initial foam height of less than about 5cm, and reducing to 0cm between about 10 seconds and 1 minute as measured in accordance with the manual shaking methodology detailed in the Experimental Methods section herein.
- The present compositions provide crystal clear use solutions at temperatures of up to and including 45°C and at water hardness levels of up to and including 23 degrees of Hardness (23° dH) on the German water hardness scale. A crystal clear use solution as defined herein is a solution having which is clear to the naked eye both on initial formulation, and after pH finishing.
- As demonstrated in the Experimental Results section hereinafter the present compositions provide desirable cleaning performance when compared to enzymatic cleansers. As further demonstrated in the Experimental Results section, the efficacious cleaning abilities of the present compositions are especially effective in the removal of blood based soils.
- Surprisingly, the present moderately alkaline non-enzymatic cleaning compositions have been demonstrated to provided material compatibilities consistent with neutral pH multi-enzyme containing cleaning compositions, and improved material compatibility (reduced corrosive potential) versus baseline (standard) alkaline pH non-enzyme containing compositions. These results are especially surprising because it is widely known that increasing the pH in cleaning compositions carries an increased risk of material incompatibility in some metal substrates.
- Even more surprisingly the present non-enzymatic cleaning compositions have been demonstrated to provide performance levels, and especially blood soil removal performance levels which are consistent with multi-enzyme containing cleaning compositions. As discussed in the Experimental Results hereinafter the present compositions show faster soil removal performance versus enzyme containing cleaning compositions. These faster cleaning results are particularly surprising because to date, enzymes have been considered to be the "gold-standard" for blood soil removal.
- As demonstrated hereinafter the present compositions provide desirable cleaning and anti-corrosive performance levels, and are particularly effective in the removal of dried body fluids, and especially of dried blood and in the inhibition of corrosion of anodized aluminum.
- The present invention can be a liquid concentrate composition comprising based on the whole composition from about 0.1 to about 15 wt. %, from about 0.1 to about 10 wt. %, from about 0.1 to about 6 wt. %, from about 0.1 to about 4 wt. %, from about 1 to about 6 wt. %, from about 1 to about 4 wt. % of a low-foam surfactant system comprising at least one nonionic surfactant.
- According to an aspect the compositions comprise from 1 to 15% of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer.
- According to a further aspect the composition includes at least two nonionic surfactants selected from one or more PO/EO/PO block copolymers and one or more ethoxylated amine block copolymers.
- According to an aspect the compositions comprise from 1 to 15% of at least one nonionic surfactant which is a PO/EO/PO block copolymer and/or an ethoxylated amine block copolymer, and optionally further surfactants wherein said further surfactants preferably comprise one or more additional non-ionic surfactants.
- Suitable PO/EO/PO block copolymers for use herein include compounds of general formula A: HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60. As will be readily appreciated the corresponding values of x and y will be dependent upon the particular EO : PO range for any particular block copolymer. For example, a PO : EO : PO block copolymer having a weight ratio of total EO to total PO of 40 : 60 and a molecular weight of 2650 will have values of x and y of about 24 for y and about 13 to 14 for x.
- Exemplary PO/EO/PO block copolymers of formula suitable for use herein include the Pluronic and reverse Pluronic nonionic surfactant ranges from (BASF), and in particular the Pluronic RPE range including Pluronic® RPE 1720, Pluronic® RPE 1740, Pluronic® RPE 2035, Pluronic® RPE 2520, Pluronic® RPE 2525, Pluronic® RPE 3110 and mixtures and combinations thereof.
- The following Pluronics are suitable for use herein: RPE 1720, having a molecular weight of 2150; RPE 1740 having a molecular weight of 2650; RPE 2035 having a molecular weight of 4100; RPE 2520 having a molecular weight of 3100; RPE 2525 having a molecular weight of 2000; RPE 3110 having a molecular weight of 3500. For the avoidance of doubt all of these Pluronic RPE materials are considered to be at 100% active.
- According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level of from about 0.1 weight % to about 15 weight % and includes at least one PO/EO/PO block copolymer of formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650.
- According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from : about 0.1 weight % to about 10 weight %; from about 0.1 weight % to about 6%; from about 0.1 weight % to about 4 weight %, and includes at least one PO/EO/PO block copolymer of formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650.
- The present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from : about 0.1 weight % to about 10 weight %; from about 0.1 weight % to about 6%; from about 0.1 weight % to about 4 weight %, and is an PO/EO/PO block copolymer of formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650.
- According to a further aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is a PO/EO/PO block copolymer having an EO : PO weight ratio of 40 : 60 and a molecular weight of 2650. An exemplary PO/EO/PO PO block copolymer having an EO : PO weight ratio of 40 :60 and a molecular weight of 2650 is PL1740. Thus in accordance with a further aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition wherein the nonionic surfactant is PL1740.
- Suitable ethoxylated amine block copolymers for use herein include alkoxylated ethylene diamines. Exemplary alkoxylated ethylene diamines for use herein are the Synperonic T series which are commercially available from Croda, Genapol ED 3030 and Genapol ED 3060 which are available from Clariant. Particular Synperonics for use herein include: SYNPERONIC T/304, alkoxylated ethylene diamine having a molecular weight of 1650; SYNPERONIC T/701, alkoxylated ethylene diamine having a molecular weight of 3600; SYNPERONIC T/707, alkoxylated ethylene diamine having a molecular weight of 25000; SYNPERONIC T/904, alkoxylated ethylene diamine having a molecular weight of 7500; and SYNPERONIC T/908, alkoxylated ethylene diamine having a molecular weight of 25000.
- According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level independently selected from: about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and includes at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650.
- The present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is present at a level which is independently selected from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %; from about 0.1 weight % to about 4 weight %, and is an alkoxylated ethylene diamine.
- According to a further aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant is an alkoxylated ethylene diamine having a molecular weight of 1650. An exemplary alkoxylated ethylene diamine having a molecular weight of 1650 is Synperonic T/304, available from Croda. Thus in accordance with a further aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition wherein the nonionic surfactant is Synperonic T/304.
- For the avoidance of doubt, where a material is described herein in terms of its general composition i.e. an alkoxylated ethylene diamine, with specific properties i.e. molecular weight of 1650, and an exemplary commercially available form is provided it will be readily appreciated that any alternative commercially available material having the same composition will also be suitable for use herein.
- In one embodiment the at least one low foam nonionic comprises Synperonic® T/304.
- According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650.
- In one embodiment the at least one low foam nonionic comprises a combination of a Pluronic RPE and a Synperonic T, and in particular Pluronics® RPE1740 and Synperonic® T/304 wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %; from about 0.1 weight % to about 4 weight %.
- The present invention is particularly useful for manual and ultrasonic cleaning of surgical instruments and endoscopes where visual inspection is helpful. As detailed hereinafter, compositions according to the invention have been demonstrated to show low foaming at in use concentration and gives a solution which in use concentration is not cloudy at a temperature in the range from 0 to 45°C.
- Further, in use liquid compositions according to the present invention have been demonstrated to provide good cleaning efficacy.
- Suitable additional nonionic surfactants for use herein include the Dehydol, Lankropol, Genapol and Hoesch ranges of surfactants. Exemplary additional non-ionic surfactants for use herein include: fatty alcohol ethoxylate C10 - C16 with 1.2 moles PO and 6.4 moles EO commercially available as Dehydol® 980, from BASF; fatty acid sulphonate commercially available as Lankropol OPA, from AkzoNobel; C12/C15 oxo alcohol PO-EO adduct commercially available from Clariant as Genapol EP 2552; and C12-C14 fatty alcohol alkoxylate 2EO/4PO copolymer commercially available as Hoesch FA 42 LF, from Julius Hoesch; and combinations and mixtures thereof.
- According to an aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- (a) 0.1 to 10.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;
- (b) 0.1 to 5.0 weight % of at least one complexing agent;
- (c) 0.1 to 10.0 weight % of at least one source of alkalinity;
- (d) 0.1 to 5.0 weight % of at least one anti-corrosion agent;
- (d) 70 to 99.6 weight % of an aqueous solvent
- According to a further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the surfactant is independently selected from: at least one PO/EO/PO block of formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is from about 10 : 90 to about 90 :10, from about 20 : 80 to about 80 : 20, from about 30 : 70 to about 70 : 30, from about 40 : 60 to from about 60 :40, or about 40 : 60 and wherein the copolymer has a molecular weight in the range of from about 2000 to about 4500, from about 2500 to about 3500, or about 2650; at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650; and mixtures of said PO/EO/PO and ethoxylated amine block copolymers.
- According to a further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the surfactant is present at a level of from about 0.1% to about 10%, from about 2% to about 8%, from about 3 weight % to about 7 weight %, or about 6 weight %, and especially wherein the surfactant is independently selected from: Pluronic 1740 at a level of from about 3 weight % to about 7 weight %, or about 6 weight %; Synperonic T/304 at a level of from about 1 weight % to about 10 weight %.
- According to an aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprises:
- (a) 0.1 to 10.0 weight % of a low-foaming surfactant system comprising at least one nonionic surfactant;
- (b) 0.1 to 5.0 weight % of at least one complexing agent;
- (c) 0.1 to 10.0 weight % of at least one source of alkalinity;
- (d) 0.1 to 5.0 weight % of at least one anti-corrosion agent;
- (d) 70 to 99.6 weight % of an aqueous solvent
- According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent: source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6.
- The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3.
- The compositions herein include one or more complexing agents at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, from about 2 weight % to about 5 weight %.
- In general, a complexing agent or a sequestrant, is a molecule capable of coordinating (i.e., binding) the metal ions commonly found in natural water to prevent those metal ions from interfering with the action of other detersive ingredients such as surfactants in a cleaning composition. Some complexing agents can also function as threshold agents when included in an effective amount. For a further discussion of complexing agents, see Kirk-Othmer, Encyclopedia of Chemical Technology, Third Edition, volume 5, pages 339-366 and volume 23, pages 319-320.
- The term complexing agent as generally defined herein is one or more agents which are capable of coordinating with metal ions in the wash water, when the compositions are used either as concentrated or diluted aqueous solutions, in order to form stable or transiently stable metal-complexes. Without wishing to be bound to any particular theory, a stable metal complex as defined herein is a complex which binds the metal ions is such a manner that they cannot interfere with the cleaning process, and in some instances such complexes may advantageously precipitate out of solution during the washing process and be simply rinsed away.
- Advantageously some complexing agents, so-called super complexing agents as particularly defined herein, are not only capable of coordinating with metal ions in natural or wash water as discussed herein but are also capable of binding with metallic components within a body soil to be removed during the cleaning process. Without wishing to be bound to any particular theory it is proposed herein that, for example in relation to blood-based soils, certain complexing agents may additionally be capable of binding to Ca-bridges within the protein-based elements of such soil and by such action enhance soil break-down and removal during the cleaning process.
- According to an aspect, the one or more super-complexing agents for use herein includes at least one complexing agents which is capable of coordinating with metal ions in natural or wash water and is capable of binding with metallic components within a body soil to be removed during the cleaning process.
- Super-complexing agents for use herein include one or more small molecule organic complexing agents including aminocarboxylic acid type sequestrants. Suitable aminocarboxylic acid type sequestrants include the acids or alkali metal salts thereof, e.g., amino acetates and salts thereof. Some examples include N-hydroxyethylaminodiacetic acid; hydro xyethylenediaminetetraacetic acid, nitrilotriacetic acid (NTA); methylglycine diacetic acid (MGDA); 2-hydroxyethyliminodiacetic acid (HEIDA); ethylenediamine tetraacetic acid (EDTA); N-hydroxyethyl-ethylenediaminetriacetic acid (HEDTA); diethylenetriammepentaacetic acid (DTPA); ethyloenediamine-tetrapropionic acid triethylentetraaminehexaacetic acid (TTHSA), and alanine-N,N-diacetic acid; N,N-diacetic acid (GLDA), methylglycinediacetic acid (MGDA), iminodisuccinate (IDS) and the like; and the respective alkali metal ammonium and substituted ammonium salts thereof; and combinations or mixtures thereof.
- Preferred herein as small molecule organic super-complexing agents are materials which when utilised in liquid concentrate compositions provide desirable cleaning performance, particularly versus blood / blood-based soils.
- Preferred small molecule organic super-complexing agents for use herein include: methylglycinediacetic acid (MGDA), and salts thereof, and especially the tri-sodium salt, commercially available from BASF as Trilon® M Liquid, and particularly where utilized as a 40% aqueous solution. Other examples of Trilon M grades include: Trilon® M Compactate, Trilon® M Granules SG, Trilon® M Granules, Trilon® M Liquid, Trilon® M Powder
- In one embodiment the at least one super complexing agent comprises MGDA.
- In one embodiment the at least one super complexing agent comprises GLDA. Examples of commercially available sources of GLDA suitable for use herein are: GLDA-Na4, N,N-diacetic acid tetra sodium salts, also known as L-glutamic acid tetra sodium salt of tetrasodium N,N-bis(carboxymethyl)-L-glutamate, available as Dissolvine GL-47-S (47% liquid), Dissolvine-PD-S (micro-granular) and Dissolvine-38 (38% liquid) from Akzo Nobel.
- According to an aspect the liquid concentrate composition herein includes one or more complexing agents wherein at least one complexing agent is a small molecule organic super-complexing agent.
- According to an aspect the liquid concentrate composition herein includes one or more complexing agents wherein at least one complexing agent is an aminocarboxylic acid or an acid or alkali metal salt thereof, and particularly wherein at least one complexing agent is methylglycinediacetic acid (MGDA), or an acid or alkali salt thereof.
- According to a further aspect the invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and/or at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650, wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and wherein the composition includes one or more complexing agents at a level of from at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, or from about 2 weight % to about 5 weight % and wherein at least one complexing agent is an aminocarboxylic acid or an acid or alkali metal salt thereof.
- In one embodiment the at least one low foam nonionic comprises a Pluronic RPE and/or Synperonic T nonionic surfactant, and in particular Pluronics® RPE1740 and/or Synperonic® T/304 wherein the level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight %, and wherein the, and particularly wherein at least one complexing agent is methylglycinediacetic acid (MGDA), or an acid or alkali salt thereof present at a level of from 0.1 weight % to about 10 weight %, from about 0.5 weight % to about 8 weight %, from about 1 weight % to about 6 weight %, or from about 2 weight % to about 5 weight %.
- Additional, optional complexing agents for use in addition to the super-complexing agents can be included. Where one or more of such optional additional complexing agents is used the total level of such agents is from 0.01 weight % to about 1 weight %. Suitable additional optional complexing agents for use herein are not limited to organic chelating compounds which sequester metal ions in solution, particularly transition metal ions. A variety of suitable additional optional complexing agents can be used in the liquid concentrate cleaning compositions herein including, for example, organic amino- or hyroxy-polyphosphonic acid complexing agents (either in acid or soluble salt forms), carboxylic acids (e.g. polymeric polycarbonate), hydroxycarboxylic acids, aminocarboxylic acids, or heterocyclic carboxylic acids e.g. , pyridine-2-6-dicarboxylic acid (dipicolinic acid), condensed phosphates, inorganic builders, polymeric polycarboxylates, and the like, and combinations or mixtures thereof. Such complexing agents are commercially available.
- Suitable condensed phosphates for use as additional complexing agents herein include sodium and potassium orthophosphate, sodium and potassium pyrophosphate, sodium and potassium tripolyphosphate, sodium hexametaphosphate.
- Exemplary commercially available additional complexing agents include: phosphonates sold under the trade name DEQUEST® from Thermos or Cublen® from Zschimmer & Schwarz or Briquest® from Rhodia including, for example, 1-hydroxyethylidine-1,1-diphosphonic acid (CH3C(PO3H2)2OH) (HEDP) DEQUEST® 2010; amino(tri(methylenephosphonic acid)), (N[CH2PO3H2]3), available as DEQUEST® 2000, or as Cublen® AP5 from Zschimmer & Schwarz, or as Briquest® 301-50A from Rhodia; ethylenediamine[tetra (methylenephosphonic acid)], available from Thermphos as DEQUEST® 2041; diethylene triamine penta(methylene phosphonic acid), available from Thermphos as DEQUEST® 2066, or as Cublen® D 3217S from Zschimmer & Schwarz; 2-phosphonobutane-1,2-tricarboxylic acid available from Lanxess as Bayhibit® AM; additional commercially available complexing agents include:; iminodisuccinate sodium salt, available from Lanxess as Baypure® CX 100/34; sodium gluconate (e.g. granular) and sodium triphosphate (available from Innpphos); Versene® 100, Low NTA Versene®, Versene® powder, and Versene® 120 all available from Dow; Dissolvine® D-40 and GL-38 available from Akzo; sodium citrate; and combinations and mixtures thereof.
- In view of the increasing complexity of the regulatory requirements relating to the use of phosphates, the present compositions preferably contain 0.5 wt. % or less of phosphate.
- According to a further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the complexing agent is independently selected from: methylglycinediacetic acid (MGDA) and/or and salts thereof, and especially the tri-sodium salt; glutamic acid, N,N-diacetic acid (GLDA) and/or and salts thereof, and especially the tetrasodium salt; and mixtures and combinations thereof.
- According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 and wherein the complexing agent is a small molecule organic super-complexing agent as defined herein, and particularly wherein the complexing agent is independently selected from: methylglycinediacetic acid (MGDA) and/or and salts thereof, and especially the tri-sodium salt; glutamic acid, N,N-diacetic acid (GLDA) and/or and salts thereof, and especially the tetrasodium salt; and mixtures and combinations thereof.
- The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent : anti-corrosion agent : source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3.
- The one or more additional complexing agents can include one or more organic phosphonates, such as an organic-phosphonic acid and alkali metal salts thereof. Exemplary suitable organic phosphonates for use herein include: 1-hydroxyethane-1,1-diphosphonic acid, CH3C(OH)[PO(OH)2]2; aminotri(methylenephosphonic acid): N[CH2PO(OH)2]3; aminotri(methylenephosphonate), sodium salt; 2-hydroxyethyliminobis (methylenephosphonic acid), HOCH2CH2N[CH2PO(OH)2]2; ethylenetriaminepenta(methylene phosphonic acid), (HO)2POCH2N[CH2CH2N[CH2PO(OH)2]2]2; diethylenetriaminepenta(methylene-phosphonate), sodium salt, C9H(28_x)N3Nax015P5 where x=7; hexamethylenediamine(tetramethylene phosphonate), potassium salt, C10H(28_x)N2Kx012P4 where x=6; bis(hexamethylene)triamine (pentamethylenephosphonic acid), (H02)POCH2N[CH2)6 N[CH2PO(OH)2]2]2; and phosphorus acid H3PO3; and other similar organic phosphonates, and mixtures thereof; 2-hydroxyethyliminobis(methylenephosphonic acid), HOCH2CH2N[CH2PO(OH)2]2; diethylenetriaminepenta(methylenephosphonic acid), (HO)2POCH2N[CH2CH2N[CH2PO(OH)2]2]2; diethylenetriaminepenta(methylenephosphonate), sodium salt, C9H(28-x)N3NaxO15P5 where x=7; hexamethylenediamine(tetramethylenephosphonate), potassium salt, C10H(28_x)N2Kx012P4 where x=6; bis(hexamethylene)triamine(pentamethylenephosphonic acid), (HO)2POCH2N[CH2)6N[CH2PO(OH)2]2]2, or salts thereof, such as the alkali metal salts, ammonium salts, or alkyloyl amine salts, such as mono-, di-, or tetra-ethanolamine salts, picolinic acid or di-picolinic acid salts or mixtures thereof.
- As used herein, the terms anti-corrosion agent or corrosion inhibitor is intended to refer to at least one of, or any combination of, the disclosed corrosion inhibitors, corrosion inhibitor intermediates, and corrosion inhibitor product formulations. A corrosion inhibitor as defined herein is an agent which either acts with or impacts upon another component in the cleaning composition such that the risk of surface damage (to the article to be cleaned) is reduced.
- As used herein, "an effective amount" is intended to refer to an amount by which the referred to component is present to perform its intended function. For example, an effective amount of a corrosion inhibitor is an amount of that component necessary to inhibit corrosion.
- It is vital in many industries that the articles or instruments used in those industries are clean and/or sterilized / disinfected. For example, in the healthcare industry, it is crucial that surgical instruments are cleaned and sterilized / disinfected after every use to ensure that the risk of contamination and infection are minimized. Many of these articles are metallic, and these metallic articles may suffer from corrosion if cleaned with an aggressive cleaning composition. As will be readily appreciated, in the surgical field in particular, patient safety is of paramount importance, and as such ensuring articles are cleaned as thoroughly as possible, will generally take precedence over the desire to ensure equipment longevity by reducing or prevention of corrosion. As such, and as referred to in the background herein, it has become a generally accepted trade-off that the need to use higher alkaline pH levels in non-enzymatic cleaning compositions to deliver a high quality of cleaning, brings an increased risk of article corrosion over time.
- Therefore, it would be advantageous to provide a non-enzymatic alkaline cleaning composition that inhibits the corrosion of articles to be cleaned without inhibiting the cleaning action of the cleaning composition.
- In a further aspect novel liquid concentrate non-enzymatic cleaning compositions for cleaning surgical, medical and dental instruments and flexible endoscopes are provided comprising:
- (a) 0.1 to 15.0 weight % of a low-foam surfactant system comprising at least one nonionic surfactant;
- (b) 0.1 to 5.0 weight % of at least one complexing agent;
- (c) 0.1 to 10.0 weight % of at least one source of alkalinity;
- (d) optionally 0.1 to 10.0 weight % of at least one additional surfactant;
- (e) 0.1 to 5.0 weight % of at least one anti-corrosion agent;
- (d) 55.0 to 99.69 weight % of an aqueous solvent
- According to an aspect there is provided a liquid concentrate non-enzymatic cleaning composition as detailed hereinbefore comprising from 0.1 wt % to 5.0 wt. % of at least one anti-corrosion agent selected from one or more phosphoric acid esters, and/or one or more phosphonic acid esters.
- Suitable for use herein as anti-corrosion agents are alkyl esters of phosphoric acid, particularly mono or di-alkyl esters, phosphonic acids and esters thereof and combinations and mixtures thereof.
- Exemplary phosphate esters for use herein include: Hordaphos® MDAH, phosphoric acid, 2-ethylhexyl ester available from Clariant; Hordaphos® MDGB phosphoric acid, mixed esters with butyl alcohol and ethylene glycol available from Clariant; and combinations and mixtures thereof.
- According to a further aspect the non-enzymatic liquid concentrate compositions as defined according to any aspect herein include at least one anti-corrosion agent at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt %. For the avoidance of doubt where one or more anti-corrosion agents are present the total level is within the levels defined hereinbefore and within 0.1 wt % to 5 wt %.
- In one embodiment the at least one anti-corrosion agent comprises Hordaphos® MDAH at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt. %.
- In one embodiment the at least one anti-corrosion agent comprises Hordaphos® MDGB at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt. %.
- According to an aspect the present invention provides a non-enzymatic liquid concentrate cleaning composition as defined herein wherein the nonionic surfactant includes at least one PO/EO/PO block of formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH wherein the relative weight ratio of EO : PO is independently selected from EO : PO ranges of : from about 10 : 90 to about 90 :10; from about 20 : 80 to about 80 : 20; from about 30 : 70 to about 70 : 30; from about 40 : 60 to from about 60 :40; about 40 : 60 and wherein the copolymer has a molecular weight in the range of from: about 2000 to about 4500; about 2500 to about 3500; about 2650, and at least one ethoxylated amine block copolymer having a molecular weight in the range of from: about 1500 to about 25000: about 1500 to about 8000; about 1600 to about 7500; about 1650 and at least one anti-corrosion agent at a level of: from about 0.1 wt % to about 5.0 wt. %; from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; about 0.95 wt % and wherein the anti-corrosion agent is an alkyl ester of phosphoric acid, particularly a mono or di-alkyl ester.
- In one embodiment the at least one low foam nonionic is a Pluronic RPE and/or a Synperonic T, and in particular Pluronics® RPE1740 and/or Synperonic® T/304 wherein the total level of low foam nonionic is from about 0.1 weight % to about 15 weight %; from about 0.1 weight % to about 10%; from about 0.1 weight % to about 6 weight %,; from about 0.1 weight % to about 4 weight % and wherein the anti-corrosion agent is independently selected from: Hordaphos® MDGB; Hordaphos® MDAH and mixtures and combinations thereof.
- According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 wherein the complexing agent is a small molecule organic super-complexing agent, and wherein the anti-corrosion agent is one or more alkyl esters of phosphoric acid.
- The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent: source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3 and wherein the anti-corrosion agent is independently selected from Hordaphos® MDAH; Hordaphos® MDGB.
- Suitable optional, additional anti-corrosion agents for use herein include phosphonic acids and phosphonic acid esters also known as phosphonates thereof for use as corrosion inhibitors herein are include organic phosphonates, condensed phosphonates, or the like, and mixtures and combinations thereof.
- The at least one phosphonic acid may include a plurality of phosphonic acid or phosphonates including, for example, organic phosphonates, condensed phosphonates, mixtures thereof, or the like. Suitable condensed phosphonates include sodium and potassium orthophosphonates, sodium and potassium pyrophosphonate, sodium and potassium tripolyphosphonate, sodium hexametaphosphonate.
- Some examples of suitable organic phosphonic acids including their corresponding phosphonates include: Alkyl (C1-C20) phosphonic acid: R[PO(OH)2], where R is C1-C20; 2-carboxy phosphonic acid: COOH[PO(OH)2]; 2-carboxyalkyl (C1-C20) phosphonic acid: COOHR[PO(OH)2], where R is C1-C20; 1 -hydroxyethane- 1 , 1 -diphosphonic acid: CH3C(OH)[PO(OH)2]2; aminotri(methylenephosphonic acid) : N[CH2PO(OH)2]3; aminotri (methylenephosphonate), sodium salt; 2-hydroxyethyliminobis(methylenephosphonic acid), HOCH2CH2N[CH2PO(OH)2]2; diethylenetriaminepenta(methylenephosphonic acid), (HO)2POCH2N[CH2CH2N[CH2PO(OH)2] 2] 2; diethylenetriaminepenta(methylenephosphonate), sodium salt, C9H(28x)N3Nax015P5 (x=7); hexamethylenediamine (tetramethylenephosphonate), potassium salt, C10H(28-x)N2KxO12P4 (x=6); bis(hexamethylene)triamine(pentamethylenephosphonic acid), (HO2)POCH2N[CH2)6N[CH2PO(OH)2]2]2; phosphorus acid H3P03; and other similar organic phosphonates, and mixtures thereof.
- Further examples include: 2-hydroxyethyliminobis(methylenephosphonic acid), HOCH2CH2N[CH2PO(OH)2]2; diethylenetriaminepenta(methylenephosphonic acid), (HO)2POCH2N[CH2CH2N[CH2PO(OH)2] 2] 2; diethylenetriaminepenta(methylene phosphonate), sodium salt, hexamethylenediamine(tetramethylenephosphonate), potassium salt, C10H(28.x)N2KxO12P4 (x=6); bis(hexamethylene)triamine(pentamethylenephosphonic acid), (HO2)POCH2N[(CH2)6N[CH2PO(OH)2]2]2.
- The source of alkalinity can be any source of alkalinity that is compatible with the other components of the liquid concentrate non-enzymatic cleaning composition. Exemplary sources of alkalinity include alkali metal hydroxides, alkali metal salts, phosphates, amines, and mixtures thereof.
- The alkalinity of a liquid concentrate composition as defined herein can be adjusted to provide a finished liquid concentrate composition having a desirable pH by adding the source of alkalinity until a pH-value of: at least 7.5; from about 7.5 to about 12; from about 7.5 to about 10.5; from about 7.5 to about 10; from about 7.7 to about 9.8; from about 8.0 to about 9.7; from about 8.5 to about 9.5; and especially about 9.5 is achieved.
- According to an aspect the source of alkalinity is one or more amines. Exemplary amines include alkanolamines selected from the group comprising triethanolamine (TEA), TEA 99%, monoethanolamine (MEA), diethanolamine (DEA), and mixtures thereof. TEA is a preferred amine for use herein.
- Exemplary alkali metal hydroxides include sodium hydroxide, potassium hydroxide, and lithium hydroxide. Alkali metal hydroxides are commercially available as pellets or beads having a mix of particle sizes ranging from 12-100 U.S. mesh, or as an aqueous solution, such as for example, as an about 45 wt.%, as an about 50 wt.%, or as an about 73 wt.% solution. A preferred form of sodium hydroxide is a 50% aqueous solution (caustic soda).
- Exemplary alkali metal salts include sodium carbonate, trisodium phosphate, potassium carbonate, and mixtures thereof. Exemplary phosphates include sodium pyrophosphate, potassium pyrophosphate, and mixtures thereof.
- According to a yet further aspect there is provided a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein the weight ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent : source of alkalinity is in of from about 4 : 1 : 4 to about 6 : 1 : 6 wherein the complexing agent is a small molecule organic super-complexing agent, wherein the anti-corrosion agent is one or more alkyl esters of phosphoric acid, and wherein the source of alkalinity is one or more amines, and especially one or more alkanolamines.
- The invention additionally provides a non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes wherein level of low foam surfactant is from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein ratio of low foaming surfactant to complexing agent is in the range of from about 2 : 1 to about 2 : 3, wherein the weight ratio of complexing agent: anti-corrosion agent: source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 5.3 and wherein the source of alkalinity is an alkanolamine, particularly TEA.
- The source of alkalinity, particularly the one or more amines, may be added to the composition in a variety of forms, including for example in the form of liquids (for amines), or as solid beads, dissolved in an aqueous solution or as a combination thereof (for alkali metal hydroxides).
- The source of alkalinity may comprises one or more different sources of alkalinity with the provision that the total level of the source of alkalinity in the present composition is form about 1 wt. % to about 10 wt. %, from about 2 wt. % to about 8 wt. %, from about 3 wt. % to about 6 wt. %, about 5 wt. % of the liquid concentrate non-enzymatic cleaning composition.
- The liquid detergent concentrate composition may optionally additionally include from 1 weight % to 20 weight % in total of one or more hydrotrope components. It is anticipated, that where present, the one or more hydrotrope components will provide added stability to the liquid concentrate cleaning compositions, primarily by stabilizing the nonionic surfactant component.
- Examples of the hydrotropes include the sodium, potassium, ammonium and alkanol ammonium salts of xylene, toluene, ethylbenzoate, isopropylbenzene, naphthalene, alkyl naphthalene sulfonates, phosphate esters of alkoxylated alkyl phenols, phosphate esters of alkoxylated alcohols, short chain (C8 or less) alkyl polyglycoside, sodium, potassium and ammonium salts of the allcyl sarcosinates, salts of cumene sulfonates, amino propionates, diphenyl oxides, and disulfonates.
- According to an aspect one or more hydrotropes are present in the liquid concentrate cleaning compositions wherein the total level of hydrotrope is provided in an amount of about 1 weight % to about 20 weight %, preferably about 3 weight % to about 15 weight %, further preferred about 5 weight % to about 15 weight %, based on the weight of the liquid concentrate cleaning composition.
- According to an aspect the hydrotrope is a 40% aqueous solution of sodium cumene sulfonate (SCS). According to an aspect the hydrotrope is a 40% aqueous solution of sodium cumene sulfonate (SCS) present at a level of from 5 weight % to about 15 weight %, and preferably about 10 weight %.
- The non-enzymatic cleaning compositions may include such additional ingredients or forms of ingredients such as are typically found in manual cleaning compositions such as one or more additional surfactants, one or more dyes, one or more perfumes or odorants, one or more preservatives or antimicrobial agents, one or more hydrotropes, one or more pH adjusting agents, one or more corrosion inhibitors, one or more anti-foaming agents, one or more viscosity adjusting or formulation stabilising agents such as thickening agents.
- The liquid concentrate non-enzymatic cleaning compositions herein may comprise additional surfactants such as one or more cationic surfactants, one or more anionic surfactants, e.g., phosphate ester, alkyl amine oxide, one or more amphoteric so-called zwitterionic surfactants and combinations and mixtures thereof. Where present the total level of additional surfactants is from 0.1 to 10 weight %.
- According to an aspect the non-enzymatic cleaning compositions herein are free of cationic surfactants. According to another aspect the non-enzymatic cleaning compositions herein are free of both cationic surfactants and amphoteric surfactants. According to one aspect the non-enzymatic liquid concentrate cleaning compositions additionally comprise from 1 to 10 weight % of one or more anionic surfactants, and optionally from 0.1 to 2 weight % of one or more anti-foaming agents.
- As discussed hereinbefore, the non-enzymatic liquid concentrate cleaning composition can include from 1 to 10 weight % of one or more anionic surfactants, and optionally from 0.1 to 2 weight % of one or more anti-foaming agents. Exemplary anionic surfactants that can be used include organic carboxylates, organic sulfonates, organic sulfates, organic phosphates and the like, particularly linear alkylaryl sulfonates, such as alkylarylcarboxylates, alkylarylsulfonates, alkylarylphosphates, and the like. These classes of anionic surfactants are known within the surfactant art as linear alkyl benzyl sulfonates (LABS), alpha olefin sulfonates (AOS), alkyl sulfates, and secondary alkane sulfonates.
- The anionic surfactants can be provided in the composition in an amount of from: 0 to about 10 weight%; from about 1 weight % to about 10 weight %; from about 2 weight % to about 9 weight %; from about 3 weight % to about 8 weight %; or about 5 weight %, based on the weight of the total non-enzymatic liquid concentrate cleaning composition, as defined hereinbefore.
- The non-enzymatic liquid concentrate cleaning compositions herein can include from 0.1 to 1 weight % of one or more cationic surfactants. Where the composition includes one or more anionic surfactants no cationic surfactant is present.
- Suitable cationic surfactants include quaternary ammonium compounds having the formula of RR'R"R"N+X-, where R, R, R" and R'" are each a C1-C24 alkyl, aryl or arylalkyl group that can optionally contain one or more P, O, S or N heteroatoms, and X is F, CI, Br, I or an alkyl sulfate.
- Each of R, R, R" and R'" can independently include, individually or in combination, substituents including 6 to 24 carbon atoms, preferably 14 to 24 carbon atoms, and more preferably, 16 to 24 carbon atoms. Each of R, R', R" and R'" can independently be linear, cyclic, branched, saturated, or unsaturated, and can include heteroatoms such as oxygen, phosphorous, sulfur, or nitrogen. Any two of R, R, R" and R'" can form a cyclic group. Any one of three of R, R, R" and R'" can independently be hydrogen. X is preferably a counter ion and preferably a non- fluoride counter ion. Exemplary counter ions include chloride, bromide, methosulfate, ethosulfate, sulfate, and phosphate.
- The quaternary ammonium compound includes alkyl ethoxylated and/or propoxylated quaternary ammonium salts (or amines).
- Preferred alkyl groups contain between about 6 and about 22 carbon atoms and can be saturated and/or unsaturated. The degree of ethoxylation is preferably between about 2 and about 20, and/or the degree of propoxylation is preferably between about 0 and about 30. In an embodiment, the quaternary ammonium compound includes an alkyl group with about 6 to about 22 carbon atoms and a degree of ethoxylation between about 2 and about 20. An exemplary cationic surfactant is commercially available under the name Berol 563 from Akzo-Nobel.
- Additional cationic surfactants suitable for use include ethoxylated and/or propoxylated alkyl amines, diamines, or triamines.
- The non-enzymatic liquid concentrate cleaning compositions herein can include from 0.1 to 5 weight % of one or more amphoteric surfactants. Examples of suitable amphoteric surfactants include capryloamphopropionate, disodium lauryl B-iminodipropionate, cocoamphocarboxypropionate, and disodium octylimino dipropionate.
- The amphoteric surfactants can be provided in the composition in an amount of about 0 weight % to about 5 weight %; from 0.1 to 5 weight %, 1 to 5 weight %; 2 to 5 weight %, based on the weight of the total liquid concentrate composition.
- The pH value of the non-enzymatic liquid concentrate cleaning composition herein can be adjusted by adding an acidic or basic pH adjusting agent. The selection of any particular agent will be dependent upon the starting pH of the liquid concentrate cleaning composition, or in use solution to be adjusted, and desired pH to be achieved. Typically, the pH adjusting agent is provided as part of the liquid concentrate cleaning composition.
- The pH adjusting agent can be provided in a form that allows it to take effect at a certain point in time during the manual or automatic washing process i.e. during use. For example, the pH adjusting agent can be coated in a manner that provides for release of the pH adjusting agent after a length of time. In addition, the pH-adjusting agent can be a component that is generated as a result of a reaction.
- Accordingly, the pH-adjusting agent can provide the desired pH shift to a second pH after the composition has been provided at the first pH for a desired length of time.
- When the pH adjusting agent is used to increase the pH, it can be referred to as an alkaline agent. Exemplary alkaline agents that can be used has been already mentioned above and referred to as "source of alkalinity". Triethylamine (TEA) and particularly 99% TEA is a preferred source of alkalinity herein.
- When the pH adjusting agent is used to lower the pH, it can be referred to as an acidifying agent. Exemplary acidifying agents include inorganic acids, organic acids, and mixtures of inorganic acids and organic acids. Exemplary inorganic acids that can be used include mineral acids such as sulphuric acid, nitric acid, hydrochloric acid, and phosphoric acid. Exemplary organic acids that can be used include carboxylic acids including monocarboxylic acids and polycarboxylic acids such as dicarboxylic acids. Exemplary carboxylic acids include aliphatic and aromatic carboxylic acids. Exemplary aliphatic carboxylic acids include acetic acid, formic acid, halogen-containing carboxylic acids such as chloroacetic carboxylic acid, and modified carboxylic acids containing side groups such - OH, - R, - OR, -(EO)x, - (PO)x, - NH2, and- NO2 wherein R is a C1 to C10 alkyl group. Exemplary aromatic carboxylic acids include benzoic carboxylic acid, salicylic carboxylic acid, and aromatic carboxylic acid modified to include as a side group at least one of halogen, - OH, - R, - OR, -(EO)x, - (PO)x, - NH2, and- NO2 wherein R is a C1 to C10 alkyl group. Additional exemplary organic acids include oxalic acid, phthlaic acid, sebacic acid, adipic acid, citric acid, maleic acid, and modified forms thereof containing side groups including halogen, - OH, - R, - OR, -(EO)x, - (PO)x, - NH2, and- NO2 wherein R is a C1 to C10 alkyl group. It should be understood that the subscript X refers to repeating units. Additional exemplary organic acids include fatty acids such as aliphatic fatty acids and aromatic fatty acids. Exemplary aliphatic fatty acids include oleic acid, palmitic acid, stearic acid, and C3-C26 fatty acids that may be saturated or unsaturated, and sulfonated forms of fatty acids. An exemplary aromatic fatty acid includes phenylstearic acid. Additional acids that can be used include peroxycarboxylic acid such as peroxyacetic acid, and phthalimidopercarboxylic acids. Additional acidic pH adjusting agents include carbon dioxide and ozone.
- According to an aspect the pH adjusting agent is an acidifying agent, more particularly an organic acid, and especially citric acid.
- According to an aspect the pH adjusting agent is an acidifying agent, more particularly an organic acid, and especially citric acid and the source of alkalinity is an amine, more particularly triethylamine (TEA).
- The pH can be adjusted by adding the pH adjusting agent and/or by allowing the pH adjusting agent to cause a pH shift. For example, the pH adjusting agent can be formed in situ by reaction and/or the pH adjusting agent can be coated and, once the coating is degraded, the pH adjusting agent can become exposed to the liquid concentrate cleaning composition.
- One or more preservatives also known as antimicrobial agents or biocides are typically included in the non-enzymatic liquid concentrate cleaning compositions herein at a total preservative level of from 0.01 weight % to 2 weight %.
- Any suitable preservative can be used. Exemplary preservatives for use include: phenoxyethanol, and 1,2-Benzisothiazol-3(2H)-on (BIT) commercially available within the Nuosept® product range from Ashland.
- According to an aspect the non-enzymatic liquid concentrate cleaning compositions include one or more preservatives at a total level of from 0.05 weight % to 1.0 weight %, from 0.1 weight % to 1 weight %.
- Various dyes, odorants including perfumes, and other aesthetic enhancing agents may also be included in the composition. Dyes may be included to alter the appearance of the composition, as for example, Patent Blue V, 4-[4,4',-Bis-diethylamino-α-hydroxy-benzhydryl]-6-hydroxy-benzol-1,3-disulfoacid, also known as iso-sulphan blue available from Sigma-Aldrich, Direct Blue 86 (Miles), Fastusol Blue (Mobay Chemical Corp.), Acid Orange 7 (American Cyanamid), Basic Violet 10 (Sandoz), Acid Yellow 23 (GAF), Acid Yellow 17 (Sigma Chemical), Sap Green (Keyston Analine and Chemical), Metanil Yellow (Keystone Analine and Chemical), Acid Blue 9 (Hilton Davis), Sandolan Blue/ Acid Blue 182 (Sandoz), Hisol Fast Red (Capitol Color and Chemical), Fluorescein (Capitol Color and Chemical), Acid Green 25 (Ciba-Geigy), and the like.
- Fragrances or perfumes that may be included in the compositions include, for example, terpenoids such as citronellol, aldehydes such as amyl cinnamaldehyde, a jasmine such as CIS-jasmine or jasmal, vanillin, and the like.
- For liquid concentrate cleaning compositions the total level at which one or more dyes, or one or more perfumes or odorants may be independently included is from about 0.0001 to about 0.2 weight %.
- As will be readily appreciated the novel non-enzymatic cleaning compositions provided herein are suitable for cleaning a wide variety of articles including: surgical, medical or dental instruments; surgical probes including flexible endoscopes; ware including food plates or platters, food containers or cutlery; beverage containers including bottles, glasses, jugs, cups or mugs.
- Such cleaning can be carried out manually or automatically in accordance with the methods detailed herein wherein the selection of the cleaning route will be dependent upon the nature of the article to be cleansed. As previously described and as exemplified hereinafter surgical, medical or dental instruments; surgical probes including flexible endoscopes are preferably cleansed using manual methods.
- As detailed hereinbefore, cleaning solutions comprising the novel non-enzymatic compositions herein are substantially non-corrosive to metals such as stainless steel, anodized aluminium, aluminium, copper and brass which are often at risk of damages when soaked in previously available alkaline cleaning products.
- The cleaning solution provided by the invention can be used for any suitable purpose.
- Preferably, it is employed as a soak cleaner for medical and surgical instruments, dental hand piece, and the like, for both human and veterinary practice. When used as a soak cleaner, it is applied before the instruments are disinfected. It can also be readily used as a concentrate to be added to ultrasonic baths and to automatic washers, for cleaning more elaborate medical equipment.
- As detailed previously herein, when employed in automatic washing systems, it is important that the surfactant, or detergent, component has low foam characteristics to avoid machine malfunction due to excessive foam formation. The cleaning and detergent solutions comprising an aqueous solution of the non-enzymatic cleaning compositions as defined herein are readily employed at elevated temperatures, as high as about 450C.
- Foreign matter to be cleaned or removed includes, for example, biological substances, e.g., tissue and blood. Foreign matter also includes other materials such as lubricant, diagnostic and therapeutic compositions, materials for pathology testing, medical or veterinary research, and the like, remaining on instruments after these are employed for their intended use. Foreign matter also includes pathogens including bacteria, viruses, and prions. For the avoidance of doubt, the term " instrument" as used herein is intended to be defined broadly, to include any articles, items, objects, implements or devices for which the gentle removal of organic or biological substances, such as protein, fats, carbohydrates and similar material is desirable. Simply by way of example and without limitation, instruments are implements employed in patient or client contact (human or veterinary) during the practice of surgery, medicine, dentistry, podiatry, pathology for e.g., therapeutic, diagnostic and/ or research purposes. Examples include, surgical instruments, e.g., scalpels, probes, clamps, etc., endoscopes, operating room or dental hand-pieces, ventilation tubes, and the like. Surgical instruments and equipment inevitably pick up amounts of bio-burden on them after being employed in operations on humans or animals.
- Surgical instruments include for example rigid and flexible probes and scopes, and specifically including flexible endoscopes, laparoscopic instruments, trays and anything that gets soiled with body fluids which result in them having varying amounts of bio-burden on them after being so used.
- Other articles that may be cleansed with solutions of the novel non-enzymatic compositions as detailed herein also include miscellaneous other instruments and/or implements employed in cosmetic and beauty applications. These applications include hair cutting, nail care, body art, skin piercing, collection of body fluids, e.g., blood, and blood separation and fractionation equipment, and similar such applications, that are too numerous to mention. The novel non-enzymatic compositions are also contemplated for use in cleaning implements and items employed in the food processing and pharmaceutical industries.
- Cleaning compositions as defined hereinbefore can be made in accordance with the following method.
- A use solution of a test composition is prepared by diluting the composition with water at room temperature (RT). For the avoidance of doubt, and unless specifically defined to the contrary, RT as defined herein is a temperature in the range of from 20°C to about 23°C, and especially about 20°C. The concentration of the test composition in water, the so-called "use solution" can be varied according to the nature of the particular assessment to be undertaken. Typically use solutions having test composition aqueous concentration levels of 10%, 5%, 1%, 0.5%, 0.3% or 0.2% can be tested using in the methods detailed herein.
- The purpose of this test is to enable to measurement of the efficiency of blood cleaning performance of different cleaning compositions. To ensure consistency in the trends in cleaning efficacy observed between different test compositions, and different test runs it is important to ensure that the test compositions are exposed to blood coupons for the same contact time. In the present test methodologies as detailed in the results section herein contact times of 5 minutes and 2 minutes have been used, although shorter or longer contact time periods may be used depending upon the nature of the substrate (metal coupon) or soil (blood etc) being tested. Furthermore, it is recommended that where it is intended to make comparisons between the results obtained for different test compositions against a particular soil on a particular coupon, that soiled coupons from a common batch are used for each test compositions in order to minimize batch-to-batch inconsistencies.
- A batch of coupons is prepared as follows: Stainless steel coupons (5x5x0.1 cm) are cleaned and degreased with acetone for preparation. The coupons were dried prior to soiling by placing them on a bench for 30min. Typically 3 coupons were tested for each concentration of a particular formula. The combined weight of all the coupons is then measured and recorded. 0.2 g of reactivated sheep blood (commercially available from for example from Fiebig-Nährstofftechnik) is weighed out and delivered onto each coupon and spread across the coupon surface. For ease of handling and to avoid contamination of the test area it can be useful to leave a small frame, typically around 3mm around the outside of each coupon thereby providing a soil-free (clean) handling area. The soiled coupons are then dried in a drying cabinet for 1 hour at 45°C. After cooling down to room temperature the combined weight of all the dried, soiled coupons is measured and recorded.
- 400ml of an aqueous use solution of a test Composition at the desired aqueous concentration level of: 0.2%, 0.5% and/or 1% is prepared in the required water (de-ionised, tap / 14°C dH DE, or Hard / 23°C dH DE as detailed hereinbefore, but at a temperature of 20°C to 23°C and added into a standard 500ml beaker. The test coupons (one coupon per beaker, 3 coupons per formula) were immersed in the test solution and left for 5 minutes without agitation, in an environment where the external temperature is from 20°C to 23°C RT. At the end of this 5 minute test solution contact time, the coupons were removed and immersed in clean water for rinsing. Then the test coupons were dried at ambient temperature (20 to 23°C) overnight.
- The level of soil removal is evaluated both visually and gravimetrically. The total starting weight of the coupons with dried blood (i.e. the pre-immersion weight) minus the total weight of the clean coupons (i.e. the pre-soiling weight) is equal to the blood load. The total weight of the cleaned coupons (i.e. the post-immersion and drying weight) minus the weight of the clean coupons (i.e. the pre-soiling weight) is equal to the blood load after cleaning, namely the remaining blood load.
- Using this approach the cleaning efficacy can be calculated. The result in form of the cleaning efficacy is given in percent. The tests were repeated a minimum of three times and average results (in percent) are reported.
- A use solution of a composition to be tested in water is prepared at room temperature (RT). For the avoidance of doubt, and unless specifically defined to the contrary, RT as defined herein is a temperature in the range of from 20°C to about 23°C. The concentration of test composition in water can be varied according to the nature of the particular assessment to be undertaken. Typically use solutions having test composition aqueous concentration levels of 10%, 5%, 1% or 0.5% are tested using this method.
- A sample of the use solution to be tested (100 ml) is poured, placed or otherwise filled into a 250 ml measuring cylinder (height: 30.5cm, width: 3.7cm). The cylinder is closed with a polyethylene (PE) plug. Any suitable PE plug which effectively seals the cylinder and prevents or substantially limits the escape of test solution can be used. The so-closed cylinder is then tilted 20 times from a substantially upright position to a substantially upended / upside down position. The resultant foam height in the cylinder is measured as soon as practicably possible following the removal of the plug. This measurement provides a baseline, 0 minute foam height. The foam height is then measured at further pre-defined time points, of 1 and 5 minutes thereafter. The foam height in the measuring cylinder is measured with a ruler and documented in millimetres (mm).
- This test is repeated minimum three times.
- Before the test the measuring cylinder is cleaned and rinsed with ethanol for degreasing; followed by rinsing with demineralized water.
- As defined hereinbefore the cloud point is the temperature where a liquid product becomes cloudy. To determine the cloud point of a test composition a use solution is prepared and an assessment of its clarity is made using the naked eye. As detailed hereinbefore a use solution is a solution of a composition to be tested in water. The concentration of the use solution of a test composition can be varied according to the nature of the particular assessment to be undertaken. Typically use solutions having test composition aqueous concentration levels of 10%, 5%, 1%, 0.5%, 0.3% or 0.2% can be tested using this method. For the avoidance of doubt where a solution is described as being "clear" in the results section herein this means that to the naked eye the solution is crystal clear, whilst a solution which is described as "turbid" is non-clear or cloudy.
- The relative stability of test compositions in different water conditions can be measured by recording the cloud points of use solutions prepared from water of different degrees of (0dH).
- The use solution at the desired concentration level is filled into a 150 ml beaker at room temperature (RT). The temperature is raised slowly and monitored with a thermometer. To ensure consistency between the results for different test samples, the means for increasing the temperature includes any suitable graduated heating method which can be pre-set or pre-programmed. The temperature at which the test composition use solution shows the first signs of cloudiness, as observed by the naked eye, during heating is documented. The heating is stopped and the solution is allowed to cool naturally. Both the solution and the temperature are observed during this cooling period. The temperature is documented when the solution first becomes clear again.
- Using this method cloud points are determined with an accuracy of 0.50C. Typically the test is repeated at least twice to ensure consistency of results.
- In-use solutions of the compositions to be tested at the desired concentration level are prepared as indicated hereinbefore. The test solutions can be prepared in de-ionised (DI) or tap water as desired. Tap water is a more likely real-life scenario, whilst DI water provides a worst-case, stress test scenario. The metal materials to be assessed for compatibility with the test composition solutions are provided as metal plates, such as for example Steel or Aluminium plates. Whilst the size of the plates can vary it is important that the same size and material of plates are used for each test solution within any group of tests. Typically plates of (12cm by 6cm by 0.1cm) are used.
- The weight of each plate is measured in its dry state prior to testing, and again post-immersion. In each case, the testing is carried out at room temperature and each test plate is fully immersed an in-use solution of 500ml of the test composition at the desired aqueous concentration, for example 0.5%, in a suitable container, such as for example in a beaker (600ml).
- After one week each of the test plates was rinsed off with DI water, dried and the weight was re-measured. On the following day the plates were immersed again (in freshly prepared test solutions) and the procedure was repeated twice more. The results obtained from this test can be provided either as raw data set or as an average data set of the average % weight loss.
- All of the compositions and methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While this invention may be embodied in many different forms, there are described in detail herein specific preferred embodiments of the invention. The present disclosure is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. In addition, unless expressly stated to the contrary, use of the term "a" is intended to include "at least one" or "one or more." For example, "a nonionic surfactant" is intended to include "at least one nonionic surfactant" or "one or more nonionic surfactant."
- Any ranges given either in absolute terms or in approximate terms are intended to encompass both, and any definitions used herein are intended to be clarifying and not limiting. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub ranges (including all fractional and whole values) subsumed therein.
- Furthermore, the invention encompasses any and all possible combinations of some or all of the various embodiments described herein. It should also be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
- The following experimental results are based on various compositions. The function, chemical and trade names of the components used in these compositions are as follows:
Component Chemical Name Trade Name Solvent Water Aqua purificata Solvent 1,2 Dihydroxy propane Propylene glycol Solvent Ethanol azeotrope 96% Ethanol azeotrope 96% Corrosion inhibitor Benzotriazole Preventol BZT Hydrotrope sodium cumene sulphonate Na cumene sulphonate, 40% Super-complexing agent Glutamic acid, N,N-diacetic acid, tetrasodium salt, 38% solution(GLDA) Dissolvine GL-38 Nonionic surfactant Fatty alcohol alkoxylate Genapol EP 0244 wetting, dispersing, and emulsifying agent. Octyl sulphate Texapon 842 Nonionic surfactant Block copolymer (PO-EO-PO) Pluronic RPE 1720 polyfunctional surfactant Sodium-N-lauryl-β-iminodipropionate Deriphat 160 C Nonionic surfactant Block copolymer (PO-EO-PO) Pluronic RPE 1740 Enzyme Protease Purafect Prime 4000L Preservative 2-Methyl-2H-Isothiazol-3-One (MIT) and 1,2-Benzisothiazol-3(2H)-on (BIT) Nuosept BM 22 Preservative Phenoxyethanol Protectol PE Alkalinity Triethanolamine 99% Triethanolamine 99% Wetting agent Propan-1,2,3-triol Glycerin pH adjust Citric acid monohydrate Citric Acid monohydrate pH adjust Sodium hydroxide, 50% solution Sodium Hydroxide 50% Nonionic surfactant Alcohols, C10-16, ethoxylated, propoxylated Dehydol 980 Anti-corrosion agent / corrosion inhibitor Phosphoric acid ester Hordaphos MDGB Nonionic Surfactant Alkoxylated ethylene diamine Synperonic T/304 Anti-corrosion agent /c corrosion Inhibitor Phosphoric acid, 2-ethylhexyl ester Hordaphos MDAH Super-complexing agent Methylglycine diacetic acid, tri sodium salt, 40% solution (MGDA) Trilon M Liquid Dye 4-[4,4'-bis-diethylamino-α-hydroxy benzhydryl]-6-hydroxy-benzol-1,3-disulfoacid Patentblue 85 E 131; Food Blue 5 Cl 42051 DRM - The purpose of this experiment was to determine whether a series of test formulations, Compositions E, F, G which contained varying levels of at least PL1740 as a nonionic surfactant and 10% GLDA as a super-complexing agent could provide desirable foam heights in combination with clarity across conditions and retain elevated (alkaline) pH. The foam height, clarity and pH retention of Compositions E, F, G were compared to an enzyme containing formulation, Sekusept Multienzyme, Composition J, and two further comparator formulations, Compositions H and I based on alternative nonionic surfactants at a total level of 4%, and each containing GLDA at 10%, and again formulated at elevated pH.
- The formulation details of Compositions E to J as well as physical properties (pH and visual appearance) of formulations E to I and multi-enzyme formulation J is also provided in Table 1. The relative composition of the components in formulations E to I are shown as weight percentages, wt. %, out of a total composition level of 100.00.
- Table 1 additionally provides data relating to foam height, as well as clarity and pH data for each formulation, at the point of manufacture, after 24 hours (at room temperature), and in 1% use solutions in de-ionised water and in tap water (14°dH DE).
- As can be seen from the results in Table 1, test Composition E which contained PL1740-alone was clear at the point of manufacture but became cloudy after 24 hours. Test Compositions F and G provided desirable clarity under all conditions and demonstrated improved foam height results both initially and after 1 minute in 1% solutions in both de-ionised and tap water.
- Again, the initial pH and pH in de-ionised water were maintained at desirable elevated levels, whilst in tap water solution the pH level fell below the pH 9.5 target.
- The foam heights were determined using the methodology as detailed in the Experimental Methods section herein. For the avoidance of doubt, the faster the foam dissipates the more desirable the foam performance.
- None of the text or comparator formulations was able to provide foam performance at the levels provided by the multi-enzyme formulation I.
TABLE 1 Component Trade Name E F G H I J Solvent Aqua purificata 75.25 75.25 75.25 75.25 75.25 N/A Corrosion inhibitor Preventol BZT 0.20 0.20 0.20 0.20 0.20 N/A Hydrotrope Na cumene sulphonate - - - - - N/A Super Complexing agent Dissolvine GL-38 10.00 10.00 10.00 10.00 10.00 N/A Nonionic surfactant Dehydol 980 - - - - 2.00 N/A Nonionic surfactant Pluronic RPE 1740 4.00 3.00 2.00 - - N/A polyfunctional surfactant Deriphat 160 C - 1.00 2.00 4.00 2.00 N/A Preservative Nuosept BM 22 0.20 0.20 0.20 0.20 0.2 N/A Alkalinity Triethanolamine 99% 10.00 10.00 10.00 10.00 10.00 N/A pH adjust Citric Acid monohydrate 0.35 0.35 0.35 0.35 0.35 N/A TOTAL 100.0 100.0 100.0 100.0 100.0 N/A Appearance clear clear clear clear clear clear, blue Appearance > 24 hours turbid clear clear clear clear clear, blue pH 10.8 / 9.5 10.3 / 9.5 10.0 / 9.5 10.0 / 9.5 10.1 / 9.5 8.6 pH in deionised 10.10 10.00 10.00 10.00 9.90 8.3 Appearance in 1% (deionised solution) - clear clear clear clear clear, bluish pH 1% in Tap water (14°dH DE) - 8.60 8.60 8.60 8.60 7.90 Appearance in 1% Tap water solution - clear clear clear clear clear, bluish Foam test/Tap water (min. / cm) - 0/5 1 / 0 0/5 1 / 1 0/7 1 /5 0/7 1 / 6.5 0/2 10sec / 0 Foam test / de-ionised water (min. / cm) - 0/5 1 / 0.7 0/6 1 /3 0/6 1 /5 0/8 1 /7 0/2 10sec/ 0 - As can be seen from the results in Table 1, test Compositions F and G provide desirable clarity under all conditions.
- A series of experiments was designed to explore the stability of the core system: the nonionic, the super-complexing agent and the source of alkalinity. Two test formulations were prepared, Composition K and Composition L, and the cores for stability were assessed via selective removal of one or more elements and observation of whether a stable formulation could be prepared. For the avoidance of doubt a stable formulation is an emulsified formulation and an unstable formulation is a formulation which separates.
- The relative composition of the components in formulations K and L are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 2.
- Table 2 additionally provides information as to the method of preparation of test Compositions K and L.
TABLE 2 Component Trade Name K Order L Order Solvent Aqua purificata 72.37 1 78.37 1 Nonionic surfactant Pluronic RPE 1740 6.00 2 - - Nonionic Surfactant Synperonic T/304 - - 10.00 2 Hydrotrope Na cumene sulphonate 10.00 3 - - Super-complexing agent Trilon M Liquid 5.00 4 5.00 3 Alkalinity Triethanolamine 99% 5.00 5 5.00 4 Corrosion Inhibitor Hordaphos MDAH 0.95 6 0.95 5 Preservative Protectol PE 0.5 7 Preservative Nuosept BM 22 - - 0.5 6 Dye Patent Blue 85 E 131 0.0015 8 0.0015 7 pH adjust Citric acid monohydrate 0.18 9 0.18 8 TOTAL 100.00 100.00 100.00 100.00 pH 9.5 9.5 - The results obtained from examination of the stability of a series of sub-formulations based on Compositions K and L confirmed that for Composition K, only the dye and citric acid could be removed without a detrimental impact on stability, whilst for Composition L, the dye, citric acid, preservative and corrosion inhibitor can all be removed without detrimental effect to the stability of the core of the emulsion composition.
- A series of experiments was designed to explore the impact of varying the MGDA level in further test formulations similar to Composition L as discussed herein before. Three test formulations were prepared, Compositions M, N, and O. Surprisingly all three compositions provided excellent foam height data as well as desirable emulsion clarity in tap water-based and hard-water based, in use solutions. This is unexpected because normally increased levels of stabilizing agents would be required to provide these levels of emulsion stability (clarity) in very hard water conditions.
- The relative composition of the components in formulations M, N and O are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 3.
- Table 3 additionally provides information as to the method of preparation of test Compositions M, N and O.
TABLE 3 Component Trade Name M N O Order Solvent Aqua purificata 75.30 77.21 68.37 1 Nonionic surfactant Synperonic T/304 - - 10.00 2 Super-complexing agent Trilon M Liquid 5.00 2.50 10.00 3 Alkalinity Triethanolamine 99% 15.00 15.00 15.00 4 pH adjust Citric acid monohydrate 1.50 2.09 3.48 5 Preservative Protectol PE 0.5 - - 6 Preservative Nuosept BM 22 - 0.20 0.20 6 TOTAL 100.00 100.00 100.00 pH 9.5 9.5 9.5 Appearance, 24h in 1% solution, tap water at 14°dH DE Clear Clear Clear Appearance, 24h in 1% solution, hard water at 32°dH DE Clear Clear Clear Foam test / Tap water (min. / cm) 0/5 20s /0 0/5 20s / 0 0/5 20s / 0 - A further series of five formulations, Compositions P, Q, R, S, T was prepared which included combination of a super complexing agent, MGDA with TEA as the source of alkalinity (at the same level in each formulation) in combination with either T304 or PL1740 (nonionics), and either Hordaphos MDAH or MDGB (corrosion inhibitors). The results presented in Table 4 illustrate the impact of varying the nonionic/corrosion inhibitor combinations.
- Comparisons between P and Q show that reducing the pH leads to initially turbid concentrates, whilst comparing R, S and T shows that increasing the pH (to 12.1) does not affect initial clarity. The final pHs of the concentrates were all -9.5. The foam test results indicate that PL1740 is a better nonionic for the provision of low foaming, than T304.
- These results also confirm, in the T304-based compositions, that varying the type or level of the corrosion inhibitors does not adversely impact upon the stability of the formulations.
- Formulation Q was prepared at a below target pH level (pH 8.62), and was found to be turbid on initial formulation, this confirms the value of maintaining the target pH level of pH 9.5 or above.
- Surprisingly the results demonstrate that compositions according to the invention, Compositions R, S and T provide clear compositions with acceptable foam performance (although not as low as for P or Q) in the absence of propylene glycol.
- The relative composition of the components in formulations P to T are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 4. Table 4 additionally provides information as to the order of addition for preparation.
TABLE 4 Function Trade Name P Q R S T Order solvent Aqua purificata 59.90 59.30 82.5 81.5 81.8 1,9 solvent Propylene Glycol 10.00 10.00 - - - - Nonionic surfactant Synperonic T/304 - - 6.00 6.00 6.00 2 Nonionic surfactant Pluronic RPE 1740 6.00 6.00 - - - 2 hydrotrope Na cumene sulphonate 10.00 10.00 - - - Complexing agent Trilon M Liquid 5.00 5.00 5.00 5.00 5.00 3 Alkalinity source Triethanolamine 99% 5.00 5.00 5.00 5.00 5.00 4 pH adjusting NaOH 50% 0.27 0.94 - - 0.34 8 pH adjusting Citric Acid monohydrate 0.2 0.2 0.2 0.2 0.2 8 Corrosion inhibitor Hordaphos MDAH 1.0 - - 1.0 - 6 Corrosion inhibitor Hordaphos MDGB - 1.0 - - 1.0 6 preservative Protectol PE 0.5 0.5 0.5 0.5 0.5 5 preservative Nuosept BM22 0.2 0.2 0.2 0.2 0.2 7 TOTAL 100.00 100.00 100.00 100.00 100.00 pH (< adjustment) 9.61 8.62 12.1 9.85 9.34 Finished pH 9.5 9.5 9.52 9.51 9.52 Appearance, on preparation Clear turbid Clear Clear Clear Foam test / Tap water, 14°dH (min. / cm) 0/3 2/0 0/3 5/0.6 0/5 1/0 0/3 1/0 0/5 1/0 - Test formulations, Compositions U and V, were prepared which were similar to compositions P and Q in Table 4, but with different water contents and without propylene glycol. The purpose of this experiment was to confirm that desirable clarity and foam performance could be provided by PL1740 nonionic formulations without PG.
- The results presented in Table 5 show that desirable clarity and foam performance are provided by PL1740 / Trilon M / TEA core formulations having differing corrosion inhibitors and no PG. In particular the foam test results demonstrate that formulation U had significantly improved foam reduction time.
- The relative composition of the components in formulations U and V are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 5. Table 5 additionally provides information as to the order of addition for preparation as well as formulation W, which was tested versus compositions Ua for cleaning efficacy as discussed hereinafter.
TABLE 5 Function Trade Name U V Order W Ua Order solvent Aqua purificata 71.8 72.1 1,9 77.77 71.84 1,9 Nonionic surfactant Synperonic T/304 - - - 10.00 - - Nonionic surfactant Pluronic RPE 1740 6.00 6.00 2 - 6.00 2 hydrotrope Na cumene sulphonate 10.00 10.00 3 - 10.00 3 Complexing agent Trilon M Liquid 5.00 5.00 3 5.00 5.00 4 Alkalinity Triethanolamine 99% 5.00 5.00 4 5.00 5.00 5 pH-adjuster NaOH 50% 0.46 0.20 8 - 0.46 10 pH-adjuster Citric Acid monohydrate - - - 0.53 - 10 preservative Nuosept BM 22 0.2 0.2 7 0.2 0.2 8 Corrosion inhibitor Hordaphos MDAH 1.0 - 6 1.0 1.0 6 Corrosion inhibitor Hordaphos MDGB - 1.0 6 - - preservative Protectol PE 0.5 0.5 5 0.5 0.5 7 dye Patent blue V - - - 0.0015 0.0015 9 TOTAL 100 100 100 100 pH (< adjustment) 9.64 9.02 9.83 9.71 Finished pH 9.5 9.49 9.51 9.5 Appearance, on preparation Clear Clear initially Clear Clear - Composition L2 which corresponds to Composition L (see Table 2), but with a lower level of MDAH was prepared. The purpose of this experiment was to determine the impact of MDAH level and whether use of a pre-mix of water / TEA / MDAH impacted on the initial formulation stability.
- Testing of Composition L2 demonstrated that at this reduced MDAH level (0.1%), versus 0.95% in Composition L, the formulation became cloudy (turbid) during manufacture as soon as the corrosion inhibitor was introduced. Additionally this could not be revised by modified addition of the MDAH in combination with the TEA and the water components. This confirms that to ensure desirable concentrate clarity and Composition stability, a level of corrosion inhibitor of greater than about 0.1% is required.
- Formulation L2 did achieve a target finished (adjusted) pH level of 9.5.
- The relative composition of the components in formulations L and L2 are shown as weight percents, wt. %, out of a total composition level of 100.00 in Table 6. Table 6 additionally provides information as to the order of addition for preparation as well as pH and clarity data. For the avoidance of doubt the data for Composition L is extracted from Table 2 hereinbefore.
TABLE 6 Function Trade Name L L2 Order for L2 solvent Aqua purificata 78.67 79.52 1,4 Nonionic Surfactant Synperonic T304 10.00 10.00 2 Complexing agent Trilon M Liquid 5.00 5.00 3 Alkalinity Triethanolamine 99% 5.00 5.00 4 pH-adjuster Citric Acid monohydrate 0.18 0.18 8 preservative Nuosept BM 22 0.20 0.2 6 Corrosion inhibitor Hordaphos MDAH 0.95 0.10 5 Dye Patentblue V 0.0015 0.0015 7 TOTAL 100 100 Finished pH 9.5 9.5 - The cleaning efficacy of compositions in accordance with the invention was tested versus a number of commercially available enzyme-containing compositions. These tests confirmed the desirable performance levels of present compositions versus these commercial compositions at both 2 and 5 minute soak times. A number of these results are illustrated and discussed hereinafter.
- Test solutions of compositions K and L (from Table 3) were prepared and diluted solutions thereof at 0.5%, in deionised (DI) water were assessed for cleaning efficacy against blood soil for 2 minutes soak time versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulations Endozyme AW Plus (from Ruhof), and a commercial multi-enzymatic comparator formulation Aniosyme DD1 (from Anios).
- The testing was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition. In each instance the plates were weighed before soiling, after soiling (with blood) and after cleaning. The percentage removal was calculated for each, as well as the average percentage removal.
empty plate plate blood after cleaning % removal Test product K, 0.5% 15.5387 15.5730 15.5396 97.3761 2 Min DI-Water 15.5884 15.6274 15.5904 94.8718 15.7839 15.8330 15.7866 94.5010 Test product L, 0.5% 15.5692 15.6161 15.5700 98.2942 2 Min DI-Water 15.5263 15.5573 15.5272 97.0968 15.7335 15.7667 15.7345 96.9880 Aniosyme DD1, 0.5% 15.5134 15.5460 15.5149 95.3988 2 Min DI-Water 15.5983 15.6341 15.6044 82.9609 15.8322 15.8718 15.8348 93.4343 Endozyme AW Plus, 0.5% 15.7974 15.8342 15.8033 83.9674 2 Min DI-Water 15.4351 15.4783 15.4373 94.9074 15.4866 15.5330 15.4905 91.5948 % blood removed Test product K, 0.5%, 2 Min DI water 95.5830 Test product L, 0.5%, 2 Min DI water 97.4597 Aniosyme DD1, 0.5%, 2 Min DI water 90.5980 Endozyme AW Plus, 0.5%, 2 Min DI water 90.1565 - The average results obtained from these three tests clearly illustrates that compositions K and L of the present invention deliver superior cleaning performance in terms of percentage blood removal after 2 minutes versus enzymatic comparator compositions. These results are very surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
- Compositions of the invention have been demonstrated to deliver improved soil removal after 2 minutes versus comparator compositions.
- The tests of 3.1.1 were repeated but with a 5 minute soak time. The average results obtained from these three tests clearly illustrates that compositions K and L of the present invention deliver superior cleaning performance in terms of percentage blood removal after 2 minutes versus both enzymatic comparator compositions. These results are very surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
- Compositions of the invention have been demonstrated to deliver improved soil removal after 2 minutes versus comparator compositions.
empty plate plate blood after cleaning % removal Test product K, 0.5% 15.5259 15.5599 15.5292 90.2941 5 Min DI-Water 15.4183 15.4601 15.4205 94.7368 15.7329 15.7768 15.7340 97.4943 Test product L, 0.5% 15.5685 15.605 15.5783 73.1507 5 Min DI-Water 15.7972 15.8376 15.8026 86.6337 15.8296 15.8743 15.8331 92.1700 Aniosyme DD1, 0.5% 15.5384 15.5738 15.5403 94.6328 5 Min DI-Water 15.5978 15.6415 15.5997 95.6522 15.8317 15.8805 15.8351 93.0328 Endozyme AW Plus, 0.5% 15.7838 15.8422 15.7854 97.2603 5 Min DI-Water 15.4397 15.4846 15.4407 97.7728 15.5126 15.5470 15.5145 94.4767 % blood removed Test product K, 0.5%, 5 Min DI water 94.1751 Test product L, 0.5%, 5 Min DI water 83.9848 Aniosyme DD1, 0.5%, 5 Min DI water 94.4392 Endozyme AW Plus, 0.5%, 5 Min DI water 96.5033 - Test solutions of compositions A1, A2, A3 and A1-a (illustrated in Table 7) were prepared and diluted solutions thereof at 0.5%, 1%, in deionised (DI) water were assessed for cleaning efficacy versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulation Sekusept from Ecolab.
TABLE 7 Function Trade Name A1 A2 A3 A1-a B1 B2 B3 B1-a Aqua purificata 75.50 73.50 75.50 74.55 85.82 83.82 85.82 84.87 Nonionic Surfactant Synperonic T/304 - - - - 4.00 6.00 4.00 4.00 Nonionic surfactant Pluronic PL1740 4.00 6.00 4.00 4.00 - - - - hydrotrope Na cumene sulphonate 10.00 10.00 10.00 10.00- - - - - Complexing agent Trilon M Liquid 5.00 5.00 - 5.00 5.00 5.00 - 5.00 Complexing agent Dissolvine GL-38 - - 5.00 - - - 5.00 - Alkalinity Triethanolamine 99% 5.00 5.00 5.00 5.00 5.00 5.00 5.00 5.00 Corrosion inhibitor Hordaphos MDAH - - - 0.95 - - - 0.95 preservative Protectol PE 0.5 0.5 0.50 0.5 - - - - pH-adjuster Citric Acid monohydrate - - - - 0.18 0.18 0.18 0.18 TOTAL 100.00 100.00 100.00 100.00 100.00 100.00 100.00 100.00 pH before adjustment 11.77 11.52 11.45 9.82 12.00 12.00 11.90 9.90 Finished pH 9.52 9.52 9.5 9.53 9.5 9.5 9.5 9.5 - The test was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition. In each instance the plates were weighed before soiling, after soiling (with blood) and after cleaning. The percentage removal was calculated for each.
empty plate plate blood after cleaning % removal Sekusept Multienzyme 0.5% 15.2616 15.2921 15.2667 83.2787 2 Min in DI-H2O 15.5983 15.6384 15.6049 83.5411 15.7780 15.8164 15.7814 91.1458 A1 0.5% 15.7979 15.8275 15.8065 70.9459 2 Min in DI-H2O 15.7929 15.8368 15.7982 87.9271 15.8334 15.8617 15.8359 91.1661 A2 0.5% 15.8028 15.8314 15.8074 83.9161 2 Min in DI-H2O 15.8302 15.8652 15.8361 83.1429 15.7676 15.8071 15.7707 92.1519 A3 0.5% 15.5263 15.5670 15.5287 94.1032 2 Min in DI-H2O 15.4881 15.5189 15.4926 85.3896 15.5948 15.6285 15.5985 89.0208 A1-a 0.5% 15.7339 15.7792 15.7431 79.6909 2 Min in DI-H2O 15.8266 15.8620 15.8299 90.6780 15.8328 15.8632 15.8361 89.1447 - Surprisingly the average results obtained from these three tests clearly illustrate that compositions of the present invention deliver cleaning performance at similar levels to that of the comparator enzyme containing composition. These results are surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
% blood removed Enzymatic Cleaner, 2 Min DI-H2O 85.9886 A1, 2 Min DI-H2O 83.3464 A2, 2 Min DI-H2O 86.4036 A3, 2 Min DI-H2O 89.5045 A1-a, 2 Min DI-H2O 86.5046 - Test solutions of compositions B1, B2, B3 and B1-a (from Table 8 were prepared and diluted solutions thereof at 0.5%, 1%, in DI water were assessed for cleaning efficacy versus correspondingly diluted solutions of a commercial multi-enzyme comparator formulation (Sekusept) and a non-enzymatic commercially available formulation Aniosyme DD1. The test was carried out in accordance with the method described hereinbefore and three sets of results were obtained for each composition. In each instance the plates were weighed before soiling, after soiling (with blood) and after cleaning. The percentage removal was calculated for each.
empty plate plate blood after cleaning % removal Sekusept Multienzyme 0.5% 15.7705 15.8044 15.7752 86.1357 2 Min in DI-H2O 15.6371 15.6720 15.6416 87.1060 15.8033 15.8438 15.8078 88.8889 B1 0.5% 15.4515 15.4864 15.4555 88.5387 2 Min in DI-H2O 15.5054 15.5434 15.5101 87.6316 15.5486 15.5846 15.5536 86.1111 B2 0.5% 15.8099 15.8376 15.8102 98.9170 2 Min in DI-H2O 15.6575 15.8585 15.6644 96.5672 15.7038 15.7446 15.709 87.2549 B3 0.5% 15.7446 15.7807 15.7489 88.0886 2 Min in DI-H2O 15.7665 15.7983 15.7709 86.1635 15.7749 15.8095 15.7783 90.1734 B1-a 0.5% 15.7337 15.7722 15.7376 89.8701 2 Min in DI-H2O 15.7965 15.8296 15.8008 87.0091 15.7265 15.7596 15.7306 87.6133 Aniosyme DD1 0.5% 15.8023 15.843 15.8091 83.2924 2 Min in DI-H2O 15.7506 15.7892 15.7572 82.9016 15.6780 15.706 15.6813 88.2143 - As clearly illustrated the average results obtained from these three tests clearly illustrate that compositions of the present invention deliver cleaning performance at similar levels to that of the comparator enzyme containing composition, and that composition B2 delivers improved cleaning. All of the test compositions and the enzyme comparator formulation outperformed the non-enzymatic comparator formulation. These results are surprising because enzyme formulations are generally accepted to provide the gold standard in cleaning performance.
% blood removed Sekusept Multienzyme, 2 Min DI-H2O 87.3769 B1, 2 Min DI-H2O 87.4271 B2, 2 Min DI-H2O 94.2463 B3, 2 Min DI-H2O 88.1419 B1-a, 2 Min DI-H2O 88.1642 Aniosyme DD1, 2 Min DI-H2O 84.8027 - Material compatibility testing was carried out for compositions A1 to B1-a as illustrated in Table 8 and also for a comparator enzymatic composition (Sekusept Multienzyme). The method was carried out in accordance with the procedure detailed hereinbefore, and in each test case, the plates were immersed an in-use solution of the test composition at 0,5% aqueous concentration in deionised (DI) water, in a beaker (600ml).
- After a week the plates were rinsed off with DI water, dried and the weight was measured. On the following day the plates were immersed again (in freshly prepared test solutions) and the whole procedure was repeated twice more.
- The results are illustrated in Table 8.
- These results illustrate that even when tested in DI water, there was substantially no weight loss shown for compositions of the invention when tested against Steel for up to 3 weeks. As it is known that alkaline compositions can have a negative impact on compatibility with Steel these results are unprecedented.
- In addition the results demonstrate very low weight losses in DI water for a range of metals at up to 3 weeks of immersion. Whilst not wishing to be bound to any particular theory it is proposed herein that the increased weight losses observed for the present compositions with blue and red Al, versus Al-alone are pigment-associated effects.
- Given that, in reality surgical instruments are only likely to be soaked for a matter of minutes at a time, and in tap water, as opposed to the weeks of immersion in DI water in these stress condition tests, these results indicate that the present compositions are likely to compare favourably to enzymatic compositions during use.
- Material compatibility testing was carried out for compositions K and L (as illustrated in Table 2). The method was carried out in accordance with the procedure detailed hereinbefore, and in each test case, the Anodized Aluminium plates were immersed an in-use solution of the test composition at 0.5% aqueous concentration in TAP water (water hardness 14 °dH), in a beaker (600ml). The results for Composition K are shown in Table 9 and the results for Composition L are shown in Table 10.
TABLE 9 test piece Weight loss (%) 1 week 2 weeks 3 weeks Red Plate 0,0051 -0,0028 -0,0020 Blue Plate 0,0057 -0,0033 -0,0005 TABLE 10 test piece Weight loss (%) 1 week 2 weeks 3 weeks Red Plate 0,0065 -0,0028 -0,0008 Blue Plate 0,0057 -0,0027 -0,0016 - These results demonstrate that both compositions K and L show negligible weight losses in these stress test conditions. Compositions of the invention have been demonstrated to show highly desirable material compatibility when tested with both red and blue Anodized Aluminum.
Claims (15)
- A non-enzymatic liquid concentrate composition for cleaning surgical, medical and dental instruments and flexible endoscopes comprising: a low-foam surfactant system comprising a nonionic surfactant; a complexing agent; a source of alkalinity; and an aqueous solvent, wherein the composition or a use solution of the composition has a pH in the range of from pH 7 to pH 12; wherein the composition is free of an enzyme, wherein the surfactant system comprises an ethoxylated amine block copolymer, a PO/EO/PO block copolymer, or a mixture thereof, and wherein the PO/EO/PO block copolymer has a formula HO(CH(CH3)CH2O)x-(CH2CH2O)y-(CH(CH3)CH2O)xH and a molecular weight in the range of from about 2000 to about 4500, wherein the relative weight ratio of EO:PO is from about 10:90 to about 90:10.
- A cleaning composition according to claim 1 comprising:(a) 0.1 to 15.0 weight % of the low-foaming surfactant system;(b) 0.1 to 10.0 weight % of the complexing agent;(c) 0.1 to 10.0 weight % of the source of alkalinity;(d) 0 to 5.0 weight % of an anti-corrosion agent; and(e) 60 to 99.7 weight % of the aqueous solvent.
- A cleaning composition according to claim 1 or 2, wherein the surfactant system comprises from 0.1 weight % to about 10 weight % of the cleaning composition comprising the PO/EO/PO block co-polymer.
- A cleaning composition according to any one of claims 1-3, wherein the ethoxylated amine block copolymer has a molecular weight in the range of from about 1500 to about 25000.
- A cleaning composition according to any one of claims 1-4, wherein the complexing agent comprises a small molecular organic complexing agent.
- A cleaning composition according to any one of claims 1-4, wherein the complexing agent comprises a small molecular organic complexing agent independently selected from: sodium methylglycine diacetate (MGDA); N,N-diacetic acid (GLDA); and combinations thereof.
- A cleaning composition according to any one of claims 2-6, wherein the anti-corrosion agent is present at a level of from about 0.1 wt % to about 5.0 wt. %, from about 0.2 wt % to about 4 wt %; from about 0.5 wt % to about 5 wt %; or about 0.95 wt %, and wherein the anti-corrosion agent is a phosphate ester.
- A cleaning composition according to any one of claims 2-7, comprising:(a) 0.1 to 10.0 weight % of the low-foaming surfactant system comprising at least one nonionic surfactant;(b) 0.1 to 10.0 weight % of the complexing agent;(c) 0.1 to 10.0 weight % of the source of alkalinity;(d) 0.1 to 5.0 weight % of the anti-corrosion agent; and(e) 65 to 99.6 weight % of the aqueous solvent.
- A cleaning composition according to any one of claims 1-8, wherein the source of alkalinity comprises triethanolamine (TEA).
- A cleaning composition according to any one of claims 1-9, wherein the cleaning composition the use solution of the composition has a pH of between 7.5 and 10.5, between 8 and 10, between 8.5 and 9.5, or about 9.5.
- A cleaning composition according to any one of claims 1-10, wherein a weight ratio of the low foaming surfactant to the complexing agent is in the range of from about 2 : 1 to about 2 : 3.
- A cleaning composition according to any one of claims 1-11, wherein a weight ratio of the complexing agent: the anti-corrosion agent: the source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6.
- A cleaning composition according to any one of claims 1-12, wherein the low foam surfactant system is from about 0.1 weight % to about 10 weight %, from about 2 weight % to about 8 weight %, from about 3 weight % to about 7 weight %, or about 6 weight % and wherein the ratio of the low foaming surfactant system to the complexing agent is in the range of from about 2 : 1 to about 2 : 3 and wherein the weight ratio of complexing agent: anti-corrosion agent: source of alkalinity is in the range of from about 4 : 1 : 4 to about 6 : 1 : 6, from about 5 : 1 : 5 to about 5.5 : 1 : 5.5, or from about 5.2 : 1 : 5.2 to about 5.3 : 1 : 5.3.
- A cleaning composition according to any one of claims 1-13, wherein the low foam surfactant system is present in an amount ranging from about 2.0 to 10.0 weight %, the complexing agent is present in an amount ranging from about 2.0 to 10.0 weight %, the anti-corrosion agent is present in an amount ranging from about 0.5 weight % to about 3.0 weight. %, and the source of alkalinity is present in an amount ranging from about 3.0 to 8.0 weight %.
- A method of cleaning articles comprising the steps:(a) providing a metal article to be cleaned;(b) providing the non-enzymatic cleaning composition according to any one of claims 1-14;(c) applying the composition to the said article, or diluting the composition to provide an aqueous use solution;(d) cleaning said article with the composition or with said aqueous use solution.
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