CN104289468A - Method for applying polymer coating to inner surface of container - Google Patents
Method for applying polymer coating to inner surface of container Download PDFInfo
- Publication number
- CN104289468A CN104289468A CN201410315831.8A CN201410315831A CN104289468A CN 104289468 A CN104289468 A CN 104289468A CN 201410315831 A CN201410315831 A CN 201410315831A CN 104289468 A CN104289468 A CN 104289468A
- Authority
- CN
- China
- Prior art keywords
- container
- coating
- cleaning
- cleaned
- mdi
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000000034 method Methods 0.000 title claims abstract description 68
- 238000000576 coating method Methods 0.000 title abstract description 78
- 239000011248 coating agent Substances 0.000 title abstract description 69
- 229920000642 polymer Polymers 0.000 title description 8
- 238000004140 cleaning Methods 0.000 claims abstract description 47
- 239000000203 mixture Substances 0.000 claims abstract description 24
- 239000003814 drug Substances 0.000 claims description 60
- 239000000463 material Substances 0.000 claims description 22
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 14
- 229910052782 aluminium Inorganic materials 0.000 claims description 13
- 239000003945 anionic surfactant Substances 0.000 claims description 11
- 239000008199 coating composition Substances 0.000 claims description 11
- 150000002430 hydrocarbons Chemical class 0.000 claims description 11
- 229910000838 Al alloy Inorganic materials 0.000 claims description 10
- 239000003995 emulsifying agent Substances 0.000 claims description 10
- 239000004411 aluminium Substances 0.000 claims description 9
- 229930195733 hydrocarbon Natural products 0.000 claims description 9
- 239000004215 Carbon black (E152) Substances 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 8
- -1 2-ethylhexyl Chemical group 0.000 claims description 6
- 150000001447 alkali salts Chemical class 0.000 claims description 6
- 239000001488 sodium phosphate Substances 0.000 claims description 6
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 6
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 6
- 239000000839 emulsion Substances 0.000 claims description 5
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
- 150000008052 alkyl sulfonates Chemical class 0.000 claims description 4
- 239000000872 buffer Substances 0.000 claims description 4
- 239000002738 chelating agent Substances 0.000 claims description 4
- 238000000151 deposition Methods 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 claims description 4
- 229940048086 sodium pyrophosphate Drugs 0.000 claims description 4
- 235000019818 tetrasodium diphosphate Nutrition 0.000 claims description 4
- 239000001577 tetrasodium phosphonato phosphate Substances 0.000 claims description 4
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 3
- 238000013019 agitation Methods 0.000 claims description 3
- 229960001484 edetic acid Drugs 0.000 claims description 3
- 239000010977 jade Substances 0.000 claims description 3
- 229940126601 medicinal product Drugs 0.000 claims description 3
- MGFYIUFZLHCRTH-UHFFFAOYSA-N nitrilotriacetic acid Chemical compound OC(=O)CN(CC(O)=O)CC(O)=O MGFYIUFZLHCRTH-UHFFFAOYSA-N 0.000 claims description 3
- 229940074404 sodium succinate Drugs 0.000 claims description 3
- ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical compound [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 claims description 3
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- 229910000029 sodium carbonate Inorganic materials 0.000 claims description 2
- LDMOEFOXLIZJOW-UHFFFAOYSA-N 1-dodecanesulfonic acid Chemical compound CCCCCCCCCCCCS(O)(=O)=O LDMOEFOXLIZJOW-UHFFFAOYSA-N 0.000 claims 2
- 238000012423 maintenance Methods 0.000 claims 1
- 230000008569 process Effects 0.000 abstract description 18
- 239000004925 Acrylic resin Substances 0.000 abstract description 17
- 229920000178 Acrylic resin Polymers 0.000 abstract description 16
- 150000002894 organic compounds Chemical class 0.000 abstract description 8
- 239000012855 volatile organic compound Substances 0.000 abstract description 5
- 239000011230 binding agent Substances 0.000 abstract description 3
- 230000007613 environmental effect Effects 0.000 abstract description 2
- 239000000825 pharmaceutical preparation Substances 0.000 abstract 1
- 229940127557 pharmaceutical product Drugs 0.000 abstract 1
- 229940071648 metered dose inhaler Drugs 0.000 description 44
- 238000002360 preparation method Methods 0.000 description 33
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 17
- 229920002313 fluoropolymer Polymers 0.000 description 16
- 239000003380 propellant Substances 0.000 description 16
- 229940079593 drug Drugs 0.000 description 13
- 239000004811 fluoropolymer Substances 0.000 description 13
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 12
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 11
- 239000012459 cleaning agent Substances 0.000 description 11
- 239000002904 solvent Substances 0.000 description 11
- 239000000243 solution Substances 0.000 description 10
- 239000007921 spray Substances 0.000 description 8
- 239000003822 epoxy resin Substances 0.000 description 7
- 239000005416 organic matter Substances 0.000 description 7
- 229920001568 phenolic resin Polymers 0.000 description 7
- 239000005011 phenolic resin Substances 0.000 description 7
- 229920000647 polyepoxide Polymers 0.000 description 7
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- 239000000443 aerosol Substances 0.000 description 6
- 239000002131 composite material Substances 0.000 description 6
- 150000001875 compounds Chemical class 0.000 description 6
- 238000002290 gas chromatography-mass spectrometry Methods 0.000 description 6
- 239000003921 oil Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 5
- 238000003795 desorption Methods 0.000 description 5
- 235000019441 ethanol Nutrition 0.000 description 5
- 150000005828 hydrofluoroalkanes Chemical class 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 229910052749 magnesium Inorganic materials 0.000 description 5
- 239000011777 magnesium Substances 0.000 description 5
- 210000001331 nose Anatomy 0.000 description 5
- 239000004094 surface-active agent Substances 0.000 description 5
- 239000000725 suspension Substances 0.000 description 5
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 4
- 235000013305 food Nutrition 0.000 description 4
- 239000002245 particle Substances 0.000 description 4
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- 229920001577 copolymer Polymers 0.000 description 3
- 239000006184 cosolvent Substances 0.000 description 3
- 239000008367 deionised water Substances 0.000 description 3
- 229910021641 deionized water Inorganic materials 0.000 description 3
- LNEPOXFFQSENCJ-UHFFFAOYSA-N haloperidol Chemical compound C1CC(O)(C=2C=CC(Cl)=CC=2)CCN1CCCC(=O)C1=CC=C(F)C=C1 LNEPOXFFQSENCJ-UHFFFAOYSA-N 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 229920005989 resin Polymers 0.000 description 3
- 239000011347 resin Substances 0.000 description 3
- 238000005070 sampling Methods 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 238000005507 spraying Methods 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 241000196324 Embryophyta Species 0.000 description 2
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- NTIZESTWPVYFNL-UHFFFAOYSA-N Methyl isobutyl ketone Chemical compound CC(C)CC(C)=O NTIZESTWPVYFNL-UHFFFAOYSA-N 0.000 description 2
- UIHCLUNTQKBZGK-UHFFFAOYSA-N Methyl isobutyl ketone Natural products CCC(C)C(C)=O UIHCLUNTQKBZGK-UHFFFAOYSA-N 0.000 description 2
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 2
- UEEJHVSXFDXPFK-UHFFFAOYSA-N N-dimethylaminoethanol Chemical compound CN(C)CCO UEEJHVSXFDXPFK-UHFFFAOYSA-N 0.000 description 2
- CTQNGGLPUBDAKN-UHFFFAOYSA-N O-Xylene Chemical compound CC1=CC=CC=C1C CTQNGGLPUBDAKN-UHFFFAOYSA-N 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 125000001931 aliphatic group Chemical group 0.000 description 2
- 229910045601 alloy Inorganic materials 0.000 description 2
- 239000000956 alloy Substances 0.000 description 2
- 238000009835 boiling Methods 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 238000004040 coloring Methods 0.000 description 2
- ARUVKPQLZAKDPS-UHFFFAOYSA-L copper(II) sulfate Chemical compound [Cu+2].[O-][S+2]([O-])([O-])[O-] ARUVKPQLZAKDPS-UHFFFAOYSA-L 0.000 description 2
- 238000005260 corrosion Methods 0.000 description 2
- 230000007797 corrosion Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229920001971 elastomer Polymers 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 229910052731 fluorine Inorganic materials 0.000 description 2
- 239000011737 fluorine Substances 0.000 description 2
- 125000004428 fluoroalkoxy group Chemical group 0.000 description 2
- NBVXSUQYWXRMNV-UHFFFAOYSA-N fluoromethane Chemical compound FC NBVXSUQYWXRMNV-UHFFFAOYSA-N 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 229940043265 methyl isobutyl ketone Drugs 0.000 description 2
- 239000002674 ointment Substances 0.000 description 2
- 239000003960 organic solvent Substances 0.000 description 2
- 239000003973 paint Substances 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 230000001681 protective effect Effects 0.000 description 2
- 239000005060 rubber Substances 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000000080 wetting agent Substances 0.000 description 2
- XMGQYMWWDOXHJM-JTQLQIEISA-N (+)-α-limonene Chemical compound CC(=C)[C@@H]1CCC(C)=CC1 XMGQYMWWDOXHJM-JTQLQIEISA-N 0.000 description 1
- YFMFNYKEUDLDTL-UHFFFAOYSA-N 1,1,1,2,3,3,3-heptafluoropropane Chemical compound FC(F)(F)C(F)C(F)(F)F YFMFNYKEUDLDTL-UHFFFAOYSA-N 0.000 description 1
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 description 1
- ONBWNNUYXGJKKD-UHFFFAOYSA-N 1,4-bis(2-ethylhexoxy)-1,4-dioxobutane-2-sulfonic acid;sodium Chemical compound [Na].CCCCC(CC)COC(=O)CC(S(O)(=O)=O)C(=O)OCC(CC)CCCC ONBWNNUYXGJKKD-UHFFFAOYSA-N 0.000 description 1
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 description 1
- UCVLHOKPJHCDAH-UHFFFAOYSA-N C(CCCCCCCCCCC)C1=C(C=CC=C1)S(=O)(=O)O.C1(=CC=CC=C1)S(=O)(=O)OCCCCCCCCCCCC Chemical group C(CCCCCCCCCCC)C1=C(C=CC=C1)S(=O)(=O)O.C1(=CC=CC=C1)S(=O)(=O)OCCCCCCCCCCCC UCVLHOKPJHCDAH-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 241000207199 Citrus Species 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- 229910000881 Cu alloy Inorganic materials 0.000 description 1
- FVYLWKMCMSZCGK-UHFFFAOYSA-N FC(C(C(F)(F)F)F)(F)F.FC(C(C(F)(F)F)F)(F)F Chemical compound FC(C(C(F)(F)F)F)(F)F.FC(C(C(F)(F)F)F)(F)F FVYLWKMCMSZCGK-UHFFFAOYSA-N 0.000 description 1
- SECXISVLQFMRJM-UHFFFAOYSA-N N-Methylpyrrolidone Chemical compound CN1CCCC1=O SECXISVLQFMRJM-UHFFFAOYSA-N 0.000 description 1
- AMQJEAYHLZJPGS-UHFFFAOYSA-N N-Pentanol Chemical compound CCCCCO AMQJEAYHLZJPGS-UHFFFAOYSA-N 0.000 description 1
- 229920000459 Nitrile rubber Polymers 0.000 description 1
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 229920001774 Perfluoroether Polymers 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 208000018569 Respiratory Tract disease Diseases 0.000 description 1
- GIIZNNXWQWCKIB-UHFFFAOYSA-N Serevent Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 GIIZNNXWQWCKIB-UHFFFAOYSA-N 0.000 description 1
- 239000004115 Sodium Silicate Substances 0.000 description 1
- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 1
- DHKHKXVYLBGOIT-UHFFFAOYSA-N acetaldehyde Diethyl Acetal Natural products CCOC(C)OCC DHKHKXVYLBGOIT-UHFFFAOYSA-N 0.000 description 1
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 description 1
- 125000002777 acetyl group Chemical class [H]C([H])([H])C(*)=O 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 150000001252 acrylic acid derivatives Chemical class 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 description 1
- 238000005275 alloying Methods 0.000 description 1
- 238000000137 annealing Methods 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 235000015241 bacon Nutrition 0.000 description 1
- 229940077388 benzenesulfonate Drugs 0.000 description 1
- 229960004436 budesonide Drugs 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 230000000711 cancerogenic effect Effects 0.000 description 1
- 231100000357 carcinogen Toxicity 0.000 description 1
- 239000003183 carcinogenic agent Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 235000020971 citrus fruits Nutrition 0.000 description 1
- 239000011247 coating layer Substances 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- XCJYREBRNVKWGJ-UHFFFAOYSA-N copper(II) phthalocyanine Chemical compound [Cu+2].C12=CC=CC=C2C(N=C2[N-]C(C3=CC=CC=C32)=N2)=NC1=NC([C]1C=CC=CC1=1)=NC=1N=C1[C]3C=CC=CC3=C2[N-]1 XCJYREBRNVKWGJ-UHFFFAOYSA-N 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
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- 210000003298 dental enamel Anatomy 0.000 description 1
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- GVGUFUZHNYFZLC-UHFFFAOYSA-N dodecyl benzenesulfonate;sodium Chemical compound [Na].CCCCCCCCCCCCOS(=O)(=O)C1=CC=CC=C1 GVGUFUZHNYFZLC-UHFFFAOYSA-N 0.000 description 1
- 239000013013 elastic material Substances 0.000 description 1
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- 235000019634 flavors Nutrition 0.000 description 1
- 238000007646 gravure printing Methods 0.000 description 1
- 239000008233 hard water Substances 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 125000004435 hydrogen atom Chemical class [H]* 0.000 description 1
- 230000008676 import Effects 0.000 description 1
- 239000003350 kerosene Substances 0.000 description 1
- 239000010410 layer Substances 0.000 description 1
- WPBNNNQJVZRUHP-UHFFFAOYSA-L manganese(2+);methyl n-[[2-(methoxycarbonylcarbamothioylamino)phenyl]carbamothioyl]carbamate;n-[2-(sulfidocarbothioylamino)ethyl]carbamodithioate Chemical compound [Mn+2].[S-]C(=S)NCCNC([S-])=S.COC(=O)NC(=S)NC1=CC=CC=C1NC(=S)NC(=O)OC WPBNNNQJVZRUHP-UHFFFAOYSA-L 0.000 description 1
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- 210000003928 nasal cavity Anatomy 0.000 description 1
- 238000011017 operating method Methods 0.000 description 1
- 239000006174 pH buffer Substances 0.000 description 1
- JZRYQZJSTWVBBD-UHFFFAOYSA-N pentaporphyrin i Chemical compound N1C(C=C2NC(=CC3=NC(=C4)C=C3)C=C2)=CC=C1C=C1C=CC4=N1 JZRYQZJSTWVBBD-UHFFFAOYSA-N 0.000 description 1
- 239000003186 pharmaceutical solution Substances 0.000 description 1
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- 229920003023 plastic Polymers 0.000 description 1
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- 229920000728 polyester Polymers 0.000 description 1
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- 229920002635 polyurethane Polymers 0.000 description 1
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- 239000000843 powder Substances 0.000 description 1
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- 238000007639 printing Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- KCTAWXVAICEBSD-UHFFFAOYSA-N prop-2-enoyloxy prop-2-eneperoxoate Chemical compound C=CC(=O)OOOC(=O)C=C KCTAWXVAICEBSD-UHFFFAOYSA-N 0.000 description 1
- 239000011253 protective coating Substances 0.000 description 1
- 238000010926 purge Methods 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 239000012487 rinsing solution Substances 0.000 description 1
- 229960002052 salbutamol Drugs 0.000 description 1
- 229960004017 salmeterol Drugs 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000002791 soaking Methods 0.000 description 1
- 229940080264 sodium dodecylbenzenesulfonate Drugs 0.000 description 1
- 235000019795 sodium metasilicate Nutrition 0.000 description 1
- NTHWMYGWWRZVTN-UHFFFAOYSA-N sodium silicate Chemical compound [Na+].[Na+].[O-][Si]([O-])=O NTHWMYGWWRZVTN-UHFFFAOYSA-N 0.000 description 1
- 229910052911 sodium silicate Inorganic materials 0.000 description 1
- 238000000638 solvent extraction Methods 0.000 description 1
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- 230000003746 surface roughness Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- CDVLCTOFEIEUDH-UHFFFAOYSA-K tetrasodium;phosphate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]P([O-])([O-])=O CDVLCTOFEIEUDH-UHFFFAOYSA-K 0.000 description 1
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Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B9/00—Cleaning hollow articles by methods or apparatus specially adapted thereto
- B08B9/08—Cleaning containers, e.g. tanks
- B08B9/0821—Handling or manipulating containers, e.g. moving or rotating containers in cleaning devices, conveying to or from cleaning devices
- B08B9/0826—Handling or manipulating containers, e.g. moving or rotating containers in cleaning devices, conveying to or from cleaning devices the containers being brought to the cleaning device
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B9/00—Cleaning hollow articles by methods or apparatus specially adapted thereto
- B08B9/08—Cleaning containers, e.g. tanks
- B08B9/093—Cleaning containers, e.g. tanks by the force of jets or sprays
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B08—CLEANING
- B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
- B08B9/00—Cleaning hollow articles by methods or apparatus specially adapted thereto
- B08B9/08—Cleaning containers, e.g. tanks
- B08B9/20—Cleaning containers, e.g. tanks by using apparatus into or on to which containers, e.g. bottles, jars, cans are brought
- B08B9/22—Cleaning containers, e.g. tanks by using apparatus into or on to which containers, e.g. bottles, jars, cans are brought the apparatus cleaning by soaking alone
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- 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
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/02—Anionic compounds
- C11D1/37—Mixtures of compounds all of which are anionic
-
- 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
- C11D3/02—Inorganic compounds ; Elemental compounds
- C11D3/04—Water-soluble compounds
- C11D3/06—Phosphates, including polyphosphates
- C11D3/065—Phosphates, including polyphosphates in admixture with sulfonated products
-
- 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
- C11D3/02—Inorganic compounds ; Elemental compounds
- C11D3/04—Water-soluble compounds
- C11D3/10—Carbonates ; Bicarbonates
-
- 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
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/02—Anionic compounds
- C11D1/12—Sulfonic acids or sulfuric acid esters; Salts thereof
- C11D1/123—Sulfonic acids or sulfuric acid esters; Salts thereof derived from carboxylic acids, e.g. sulfosuccinates
-
- 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
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/02—Anionic compounds
- C11D1/12—Sulfonic acids or sulfuric acid esters; Salts thereof
- C11D1/22—Sulfonic acids or sulfuric acid esters; Salts thereof derived from aromatic compounds
-
- 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
- C11D1/00—Detergent compositions based essentially on surface-active compounds; Use of these compounds as a detergent
- C11D1/02—Anionic compounds
- C11D1/34—Derivatives of acids of phosphorus
Abstract
A method of cleaning and coating at least one surface of a container for holding a pharmaceutical or other ingestible non-pharmaceutical product, the method comprising the step of employing an aqueous cleaning composition in conjunction with an aqueous cross-linked acrylic resin comprising a coating. The process allows cleaning and coating techniques to meet current environmental regulations and workplace safety standards, including controlling the release of Volatile Organic Compounds (VOCs). In addition, the concentration of the organic compounds that can be precipitated is reduced to the lowest level in practice. The process can also be used with other binders that require low extractable organics and high adhesion to subsequently applied coatings.
Description
Technical field
The present invention relates to the method at least one surface of the container cleaning and apply for depositing medicine, use the unique combination thing that formed by moisture cleaning agent and special aqueous coating composition, wherein for increasing surface wettability, this aqueous coating composition is used for reducing significantly the organic matter that can separate out and provides effective medicine buffer action and lower adhesion to be inclined to this moisture cleaning agent.
Background technology
The medicine being used for the treatment of respiratory tract and nose illness is normally used with aerosol component by mouth or nose.The method of this aerosol drug of a kind of preparation be widely used composition relates to medicine is prepared into suspension or pharmaceutical solutions with the powder type of trickle separation in the liquid gas being called as propellant (propellant).This suspension is stored in and can bears pressure and to make propellant remain the container (or tank) of liquid sealing inner.Then said preparation can be sent forth by starting the metering valve that be connected with container.
This metering valve is usually designed to and discharges default and quantitative aerosol drugs preparation constantly corresponding to each startup.When being ejected container via metering valve under the hyperbar of this preparation at propellant, propellant evaporates rapidly and the air mass of the unusual fine particle of the medicine preparation forming movement rapidly.This particle air mass is via a kind of lane device, the cone cylinder of such as cylinder or opening, imports nose or the mouth of patient.While aerosol metering valve is activated, patient's Sucked medicine particle also makes it enter lung or nasal cavity.The system of dispense medication is called " metered dose inhaler " (metered dose inhaler, MDI) by this way.
Patient relies on the medicine of MDI dispensing usually with fast treating respiratory tract disease, and this kind of illness comprises, and such as, causes weak and in some cases or even life-threatening asthma and chronic obstructive pulmonary disease (COPD).The medicinal compound being used for the treatment of other symptoms or disease is also designed to adopt MDI technology to provide and deliver.Therefore, provide and deliver and stably must reach technical specification that manufacturer proposes to the aerosol drug of patient prescription's dosage and meet the requirement of U.S. food and FAD (FDA) and other supervision departments.That is, each dosage in tank must be identical in the range of tolerable variance of precision.
In some cases, aerosol drugs preparation may be easy to adhere to and/or with the inner surface chemically reactive of MDI (comprising the tank cylinder forming MDI device), metering valve and block.The medicine obtained when patient may be caused so at every turn to start corresponding to MDI is starkly lower than the amount of regulation.Therefore, be usually necessary the interior surface at MDI, comprise the inner surface of metering valve and container, in covering, coating material is to prevent medicine preparation to be attached to or to react with MDI inner surface.
Before this, the fluoropolymer being just used as different article protective coating in decades by knowing is used as protective materials to be coated in the inner surface of the Al and Alalloy tank cylinder for storing and use the medicine for lung in more a little; Brugger etc. at United States Patent (USP) 6,596, in 260 and Ashurst etc. at United States Patent (USP) 6,546,928 and 6, described by all having this in 532,955, and the content of these patents is all incorporated to herein by reference and all at this.Use these fluorine materials to protect the inner surface storing medicine preparation container also to allow to use the propellant system substituted, and prevent medicine preparation by the compound of such as aluminium or aluminium simultaneously pollute.
But in some cases, these fluorocarbon polymers can be solvent-based and non-water based.The formulation for coating material of many prior aries contains the solvent of energy decomposing polymer material and makes it spray.These solvents of the prior art comprise the aromatics organic compound of such as 1-METHYLPYRROLIDONE, methyl iso-butyl ketone (MIBK), dimethylbenzene and/or toluene, and all these compounds are all suspected of carcinogen.In addition, solvent based cleaning solution is normally used for treatment surface to allow to apply coating thereon.
Similarly, to be also necessary to reduce in coating process use and the amount of the separated out organic matter (such as solvent) of the content of container can be polluted.The further unfavorable conditions using flammable organic solvent to have is that the equipment for carrying out applying needs preventing the appropriate protection in fire or explosion accident.In addition, these coating needs to add a kind of binding agent in the polymer again, otherwise coating can not be adhered to surface fully.This binding agent possibility when applying or configure is expensive and consuming time, also may become the pollution sources of medicine.
Any coating putting on internal tank surface will inevitably come in contact with medicine preparation, is thus especially necessary to make to separate out organic amount contained by coating low, like this, would not interacts between paint ingredient and medicine preparation.
Develop a kind of improving technique method of coating MDI tank (comprising aluminium alloy and deep-draw MDI tank), as described herein, it adopts a kind of water-based of uniqueness to clean the inner surface coating of composition in conjunction with a kind of water-based cross-linked epoxy acrylate or other polymer.Exploitation of the present invention makes cleaning and paint-on technique meet existing environmental legislation and work safety specification, comprises the release controlling VOC (VOCs).In addition, the present invention also makes the concentration can separating out organic compound be reduced to floor level in practice.
Before process as herein described, most MDI tank adopts the hydro carbons of proprietary commercial offers and emulsifier mixture to carry out solvent clean.Although this mode can remove the hydrocarbon lubricants of the major part produced by deep-draw technique, the surface obtained can with residual oils and aliphatic acid, thus surface can be hindered soak by water paint.Before the MDI tank of coating cleans in this way, be usually heated to more than 200 DEG C to burn residual hydrocarbon compound.But the surface after process, can not come moistening by use coating completely.Coating described herein also can be applied to the surface processed in this way, but can't guarantee that best caking property and minimizing remain organic compounds.Develop a kind of cleaning method without hydrocarbon and also eliminated with the surface wettability greatly improving MDI tank the subsequent contamination brought by hydrocarbon residues.The example of prior art cleaning solvent comprise the emulsible of Silksol and other types and can be semi-emulsifying varsol purging system.These usually can comprise a kind of aliphatic solvent being similar to kerosene and promote the surfactant with water emulsification effect with one or more.
Therefore, the present invention is intended to solve the problem existing for prior art.Object of the present invention is also to provide a kind of fluoropolymer that adopts to apply improving one's methods of medical hold-up vessel inner surface; there is better protective value to provide a kind of and do not need more meticulous, the more all even flawless coating of adhesive or bed material, and this coating is only containing the separated out organic compound of minimum flow.The present invention also aims to provide a kind of method adopting aqueous polymers suspension container, and overcome prepare high-quality coating by aqueous polymers suspension and but do not use traditional volatile organic hydrocarbon solvent time involved difficulty.
Summary of the invention
The object of the present invention is to provide a kind of coating for storing the method for the vessel surface of medicine preparation, occurring to bond or chemical reaction to prevent medicine preparation and the coated surface of this container.
Another object of the present invention is to provide a kind of cleaning combination for clean container surface before being applied in coating.
Another object of the present invention is to provide a kind of aqueous clean combination and aqueous coating composition, it can be applied to the surface of the container of storage medicine preparation.
Another object of the present invention is to provide a kind of aqueous clean combination and aqueous coating composition, it is substantially free of the separated out organic compound that can react with medicine preparation.
Another object of the present invention is to provide a kind of method adopting the improvement of the inner surface of composition coated medicament tank (such as MDI) of the present invention.
Another object of the present invention is the application composition providing a kind of water-based, and it can be attached to the inner surface of medicine storage container well.
Finally, the present invention relates to a kind of method applying at least one surface of the container of storing drugs, it comprises the following steps:
A) with at least one surface of moisture cleaning solution clean container, wherein this moisture cleaning solution comprises: i) anionic surfactant; And ii) emulsifying agent;
B) apply cleaned surface with the moisture application composition containing acrylic resin (acrylic resin), this acrylic resin is selected from acrylic acid epoxy resin (acrylic epoxy resins), acrylate phenolic resins (acrylic acrylate phenolic resins) and fluoropolymer composite acrylic resin (fluoropolymer composite acrylic resins); And
C) cross-linked coating composition makes to provide at least one of container the coating continuing bonding on the surface.
Detailed description of the invention
The present invention relates to improving one's methods of a kind of coating container (being especially used for storing the container of medicine preparation) inner surface, to prevent from being stored in medicine preparation in container and vessel surface occurs to adhere to or chemical reaction, thus medicine preparation can carry out dispensing by the dosage of Accurate Measurement.In addition, the present invention relates to a kind of coating for storing improving one's methods of the inner surface of container of medicine preparation, it does not comprise the separated out organic compound that can react with the medicine preparation be stored in container substantially.
Especially, the present invention relates generally to that the method applied is carried out on a kind of at least one surface can absorb the container of non-medicinal product for storage of pharmaceutical or other, the method comprises the following steps:
A) with at least one surface of moisture cleaning solution clean container, wherein this moisture cleaning solution comprises: i) anionic surfactant, and ii) emulsifying agent;
B) apply cleaned surface with the moisture application composition containing acrylic resin (acrylic resin), this acrylic resin is selected from acrylic acid epoxy resin (acrylic epoxy resins), acrylate phenolic resins (acrylic acrylate phenolic resins) and fluorine polymeric composite acrylic resin (fluoropolymer composite acrylic resins); And
C) cross-linked coating composition makes to provide at least one of container the coating continuing bonding on the surface.
In a preferred embodiment, method of the present invention is used to the inner surface applying MDI, in particular for storing the inner surface of the cylinder tank of medicine preparation.Term " metered dose inhaler " (metered dose inhaler or " MDI ") is defined as a kind of unit be made up of with the curling medication dosing valve being placed in cap container.Term " medication dosing valve " (drug metering valve) or " MDI valve " refer to valve and associated mechanisms thereof, to be provided and delivered the medicine of accurate quantification or medicine preparation from MDI by the startup of each valve.Metered dose inhaler also comprises lane device usually, such as starting drive and the cylindrical or conial channel (such as mouthpiece starter) of valve, mouth or the nose of patient can be dispensed into through MDI valve from the MDI tank be full of through this passage medicine or medicine preparation.Metered dose inhaler is well-known in the prior art, and associated description can be see, the United States Patent (USP) 5,284 of such as Burns etc., the United States Patent (USP) 6 of the United States Patent (USP) 5,447,150 of 133, Bacon etc. and Greenwood etc., 615,827, its respective content is all incorporated to herein by reference and all at this.
Term " medicine preparation " is defined as medicine or other medical active agent and can strengthens activity or the non-active ingredient of medicine preparation configuration or MDI device operating characteristics in conjunction with other, it includes but not limited to surfactant, anticorrisive agent, flavor enhancement, antioxidant, anti-agglomerating agent and cosolvent, such as ethanol and second diether.
Preferred medicine preparation comprises, such as salbutamol, salmeterol, budesonide, individually or with other active ingredient combinations.Other medicine preparations may known by those skilled in the art.
At this, term " propellant " refers to that its boiling point of medicinal inert liquid is that about room temperature (25 DEG C) arrives approximately-25 DEG C, it at room temperature can produce hyperbar alone or in combination.When MDI device is activated, the hyperbar of the propellant in MDI orders about quantitative medicine preparation and disengages then propellant from metering valve and very rapidly evaporate and disperse drug particles.Low boiling fluorocarbon for propellant of the present invention, such as 1,1,1,2-HFC-134a (1,1,1,2-tetrafluoroethane) is also referred to as " CF3CFH2 " or " P134a ", with 1,1,1,2,3,3,3-heptafluoro-propane (1,1,1,2,3,3,3-heptafluoropropane) also referred to as " CF3CHFCF3 " or " P227 ", or hydrofluoroalkane (hydrofluoroalkane, HFA), etc.
In a preferred embodiment, MDI container and metering valve housing are made up of aluminium, aluminium alloy, stainless steel, although other metals that can not affect by medicine preparation, as copper alloy, sheet tin, also can use.MDI container also can be made with glass or plastics, although the container adopted in technical process of the present invention is preferably made with aluminum or aluminum alloy.Preferred material comprises the aluminium alloy such as containing magnesium, copper and/or manganese, such as aluminium 5052 or aluminium 3004.
Medication dosing valve generally includes the parts, medicinal inert material and the polymer of resistance to propellant that adopt stainless steel to make, and such as acetal, polyamide are (such as
), Merlon, polyester, fluorocarbon polymer (as
), or the composition of these materials.In addition, the sealing of different materials and O shape ring (such as: acrylonitrile-butadiene rubber, polyurethane, acetyl resin, fluorocarbon polymer), other elastomeric or thermoplastic elastic materials can be applied to valve or its around.The example described about medication dosing valve asks for an interview the UK Patent Application 2,361,228 of the U.S. Patent Publication 2004/0222244 of Groeger etc. and Groeger etc., and its respective content is all incorporated to herein all by reference at this.
Once deep-draw container is made, this container just via moisture cleaning step to remove the hydrocarbon lubricant that produces in deep-draw process, and provide one and there is high surface energy and the surface machined obviously can not separated out organic compound by gas chromatographic analysis.This weakly alkaline cleaning process also can increase specific area, thus improves the cohesive with after-applied coating.
The selection of cleaning agent and the control of rinse water are important for process described herein, because relate in some embodiments, base material can be just not coated through cleaning, thus cleaned surface can be suitable for patient's contact.For this reason, cleaning agent must meet the regulation of the relevant food contact of FDA Food and Drug Administration (FDA).
For some cleaning agents based on environmentally friendly solvent, it is modal is fourth oxyethanol, evaluates.Fourth oxyethanol is cleaning agent, as
(supply of Alconox company) and Simple
in a kind of active component.Although these cleaning agents can remove oil effectively, the surface energy produced is too low and can not carry out suitable soaking by aqueous coating.
Also test for the cleaning agent based on the oil plant obtained by citrus (as citrene and citrate), but these cleaning agents also fail to provide sufficiently high surface energy.Same, the cleaning agent comprising sodium metasilicate was also tried out, but in production process, the pollution of equipment and the delay pollution of microcosmic silicate deposit thing make its applicability reduce.
Correspondingly, cleansing composition as herein described is determined to provide excellent result.Especially, cleansing composition of the present invention generally includes:
1) anionic surfactant; And
2) emulsifying agent.
In one embodiment, cleansing composition also comprises at least one basic salt and buffer.These components can be added the corrosion preventing aluminum and its alloy with extension property and balance sysmte.These components can also provide more stable operating characteristics and extend the service life of cleaning agent.
Optionally, but be also preferred, cleaning combination of the present invention can also comprise a kind of metal-chelator.
Suitable anionic surfactant comprises neopelex (sodium dodecylbenzene sulfonate), alkylphosphonic (alkyl phosphate), alkylsulfonate (alkyl sulfonate), alkylbenzenesulfonate (alkyl benzenesulfonate), two (2-ethylhexyl) semi-annular jade pendant sodium succinate (sodium di (2-ethylhexyl) sulfosuccinat).Preferably, anionic surfactant is dodecyl benzene sulfonate (dodecylbenzene sulfonate).Anionic surfactant is used to penetrate the oil film on deep drawing can and is disperseed by oil plant at the cylinder of cleaning.
Emulsifying agent is provided for the oil droplet suspension in cleaning solution.A kind of preferred emulsifying agent for the present composition is sodium pyrophosphate (tetrasodium phosphate), and it also extends the stability of cleaning fluid as pH buffer.Other emulsified compounds also can be used for the present invention, but sodium pyrophosphate is preferred because it can simultaneously as buffer.
A kind of basic salt can be used to maintain high pH value (in use ensureing stable basicity), simultaneously also can in conjunction with the composition magnesium in hard water and calcium.This is also important, because jar adopts the alloy containing magnesium to be made by deep-draw technique, and magnesium is partially removed in cleaning process.A kind of preferred basic salt is sodium carbonate.Other basic salts also can obtain, but but seldom can be used to the occasion that comes in contact with people, if do not comprise basic salt, magnesium may form precipitation and pollute the surface of jar.
Selectively, but be also preferred, a kind of functionally as the material of alkaline emulsion agent and metal-chelator, as sodium phosphate, be added in composition of the present invention.Sodium phosphate and corrupt split form stable compound.In this situation, this contributes to reducing and from aluminium, decomposes alloying element and the corrosion on tank surface that causes and variable color.Although sodium phosphate is not crucial component, it provides the stability of technique really.Other alkaline emulsion agent used in the present invention comprise, example and being not limited to, ethylenediamine tetra-acetic acid (EDTA), porphines (porphine), nitrilotriacetate (nitrilo triacetate, NTA), ethylenediamine (ethylenediamene) etc.
Cleaning process generally includes the continuous print cleaner bath that two or three temperature maintain about 25 DEG C to about 60 DEG C (being more preferably about 50 DEG C).The pH value of cleaner bath, between 9 and 9.8, most preferably is 9.2.Water for the preparation of rinsing solution preferably has the conductivity lower than about 200 μ S/cm, and its hardness controls to be measure with Deutschland hardness index (German Hardness scale) 0.Cylinder tank is soaked in 1-5 minute in each cleaner bath, but preferably about two minutes.
At one preferred embodiment, each cleaner bath at about 30kHz to ultrasonic agitation between about 43kHz, but preferably about 40kHz superpose frequency sweep 1kHz.The pallet piling jar for each is controllably used oil content separating process and adds new cleaning fluid.
In a specific embodiment, container open end to be cleaned is upwards placed, while to ground, limit code in pallet, it can hold about 1000 containers.These pallets are down into each cleaner bath so that each jar is filled facing downward by edge.Then constantly cyclically upper and lower with lower tray on each cleaner bath surface, then mention, turn, be full of, repeated washing circulation 2-4 time in each cleaner bath, override is 3 times.Other configurations can be known to those skilled in the art dawn.
What continue after cleaning is multiple flushed channels, and it can comprise 3 or 4 continuous print flushed channels.First can or can not be by ultrasonic agitation, but is preferably stirring.Rinsing bath temperature remains between about 18-27 DEG C, but most preferably at about 25 DEG C.Hardness of water controls lower than 50 μ S/cm, hardness counts 0 with Deutschland hardness index degree by measuring conductivity.
Final flushed channel preferably comprises deionized water, its conductivity controls between 4 and 20 μ S/cm, but override is 5-10 μ S/cm and hardness controls counting 0 with Deutschland hardness index.The pH scope of this cleaner bath, from 5.8 to 7.0, most preferably be 6.8, and temperature is between 18 DEG C to 27 DEG C, but most preferably is 25 DEG C.
Dry in the filtered air of container then in laminar flow drying oven.
Container after cleaning is test and found that it has following surface nature.
Can separate out organic matter adopts By Gas Chromatography-mass Spectrometry (GC/MS) to detect through multiple sampling method, as shown in table 1.
Table 1 can separate out total amount of organic
Sampling method | Organic matter can be separated out and be detected total amount |
Thermal desorption (being warming up to 320 DEG C) | <1ppm |
Ethanol extraction | <1ppm |
Dichloromethane extraction | <1ppm |
The Humid Status of cleaned MDI vessel surface can adopt Contact-angle measurement method to determine.In one embodiment, the surface energy of vessel surface is about 60 with approximately between 72dyne-cm, and even more preferably about 68 to about 70dyne-cm.
Cleaning process of the present invention does not need to remove residual organic matter by cleaning after-baking.This is very crucial, because also increase the operation energy consumption of equipment while that heat treatment reducing the intensity of aluminium alloy.
Once matting completes, container will enter and apply its inner surface or the operation of lining.
A kind of special metered dose inhaler (MDI) is developed in order to the active medicine for lung or nose of controllably providing and delivering in technical process of the present invention.This MDI comprises the container of lining, and it can be obtained by above-mentioned technical process of the present invention.
Different coating compositions has obtained developing the inner surface for MDI tank.These coating are all water-based and must put on the aluminum or aluminum alloy surface not having hydrocarbon residual.These coating drop to alap degree through special exploitation can separate out organic matter and match with a series of propellant, it includes but not limited to hydrogen fluorocarbon (HFC), and/or hydrofluoroalkane (HFA), and/or ethanol, these materials can as propellant and/or formula cosolvent.In addition, select these coating to avoid using the heat treatment process of latter more than 250 DEG C of any coating, thus avoid the intensity of MDI tank to reduce after annealing.Just because of this, the MDI tank of thin-walled can adopt tank wall thickness to be less than about 0.4mm and keep necessary pop strength simultaneously.
Coating is applied in MDI tank, and adopts aforesaid method to clean.In a specific embodiment, coating processes can adopt inner air spray gun, and it describes the United States Patent (USP) 7,205,026 of visible such as Groeger etc., and its content is all incorporated to herein by reference at this.In a specific embodiment, 2 to 3 spray guns are used to each container, and the spray gun of one of them is placed vertically, and separately one or two spray guns from 0 degree skew about 10 degree and about 30 degree between, preferably at about 20 degree.Tank rotates with the speed between about 3000 to 7000rpm in coating procedure, most preferably is about more than 4500rpm.Spray gun is just introduced in tank when coating processes starts, and starts spraying when spray gun is drawn back.The time of spraying and the region of spraying are controlled to the uniform fold guaranteeing consistent coating layer thickness between 4 to 12 microns, and it most preferably is 4 to 8 microns.When coating, the temperature of container, usually between about 20 and 45 DEG C, most preferably is between about 30 to 40 DEG C.In another embodiment, aqueous coating composition can be applied by the mode of dip-coating or roller coat.
Coating available in enforcement of the present invention is based on acrylic polymers or its improvement thing.These coating are water-based emulsions, and all at least there is no any aromatics organic solvent.All these exploitations are all compatible with the MDI propellant (comprising ethanol as cosolvent) used at present.
The type specification of coating is as follows:
(1) E3: acrylic acid epoxy resin (acrylic epoxy resins).The example of acrylic acid epoxy resin used in the present invention can be " Coating Suitable for Medicament Contact " see the title of Schutte etc., and attorney docket is the patent application of 0619240100, and itself and the application submit on the same day.
(2) E4: water-and acrylate phenolic resins (Water-based acrylic acrylate phenolic resins).This acrylate phenolic resins source is Valspar, Inc..The description of such coating also can see the U.S. Patent No. 7,037,584 of such as Wind etc., and its content is all incorporated to herein herein by reference.
(3) E5: low surface energy coatings, such as fluoropolymer composite acrylic resin (fluoropolymer composite acrylic resins).A suitable source of this low surface energy coatings is Valspar, Inc..
Acrylic acid resin composition of the present invention is by least one E3 of 20-40wt.%, E4 and/or E5 acrylic resin and form as wetting agent in conjunction with one or more different alcohol.The alcohol example as wetting agent available in enforcement of the present invention, include but not limited to, n-butanol (about 2-10wt.%), 2-fourth oxyethanol (about 2-10wt.%), and/or 2-(dimethylamino) ethanol (about 1-5wt.%), and amylalcohol, its residue composition is water.The concentration of acrylic resin is adjusted to best spray efficiency, surface smoothness, Thermal desorption performance, and its optium concentration is between 22 to 27wt%.
For all these resins, crosslinked composition is the main chain being aggregated to acrylate copolymer.In addition, the microemulsified aqueous dispersion also comprising a kind of fluoropolymer of E5 resin, its particle size, between 0.1-1.0 μm, most preferably is between 0.1-0.3 μm.The structure of this fluoropolymer may be single Fluoroalkyloxy (monofluoroalkoxy), crosses Fluoroalkyloxy (perfluoroalkoxy) or other fluoropolymers (fluoropolymer) or fluorinated copolymer (fluorinated copolymer).Fluoropolymer is added to acrylic resin substrate with the concentration between 10 to 50wt%, and most preferred concentration is between 15 to 25wt%.Generally desirable situation is that fluoropolymer emulsifying agent is not containing saccharification surfactant or other surfactants that can cause pitch deposition in curing oven.On the contrary, general preferred ethoxylated surfactant.
And then apply the step of coating, tank is heated to the temperature starting coatings chemistry crosslinked action in stove.Its temperature and time are at this temperature based on the mensuration to crosslinking coatings density and are selected the mensuration of VOC desorb by By Gas Chromatography-mass Spectrometry.
E3 and E4 material is cross-linked at the temperature between about 210 DEG C to about 250 DEG C, most preferably is between about 220 DEG C to about 230 DEG C.Crosslinked and needed for Thermal desorption time is between about 5 to 12 minutes, most preferably between about 8 to 10 minutes.E5 material is cross-linked at the temperature between about 210 DEG C to about 250 DEG C, most preferably between about 230 DEG C to about 240 DEG C.It is between about 6 to 13 minutes that E5 material carries out crosslinked and needed for Thermal desorption time, most preferably between 10 to 12 minutes.
In one embodiment, coating of the present invention can mix to provide false proof basis with various colouring agent.Have the painted inner surface do not manifested from outside especially, it is unique that this inner surface can be made into for particular manufacturer and/or product.Like this, container indeed through color-coded, thus can not place medicine preparation improperly.Colouring agent comprises various phthalocyanine blue (phthalocene) and metal oxide and other and meets the regulation of 21CFR175.300 and can be used for the compound of Food Contact purposes.In other embodiments of the present invention, formulation for coating material can be transparent, opaque or translucent.
In addition, coating composition is the inner surface be described as applying MDI container at this, but coating composition also can be used for the metering valve processing MDI.
It is as follows that the existing method of the various surface propertys of the embodiment of coating of the present invention lists in table 2.
The measurement of table 2, surface property
(1) WACO test adopts Wilkens Andersen Enamel Rater II testing arrangement to carry out at 6.3 volts of direct currents, and detection time is 4.0 seconds.Measure under the state that electric current fills sodium chloride solution completely at tank, this sodium chloride solution dissolves with 10wt% sodium chloride to prepare in deionized water.
(2) surface energy determines by measuring the contact angle between surface and setting volume water droplet having applied tank.Microscope through calibration is used for these and measures.
(3) can precipitate be adopt gas chromatography/mass spectrometry detector (GC/MS) to measure.The solvent extraction of pure (99.9%) absolute ethyl alcohol and Thermal desorption method is adopted to be used as the method for sampling.Can the measurement of extract also similar, after moisture is removed, residue is dissolved in carrene.
(4) copper sulphate resistance test adopts conventional test liquid to carry out, and this experimental liquid is water-soluble by about 0.2wt% copper sulphate, then the hydrochloric acid adding about 0.02wt% acidifying and being formed slightly.Corrosiveness is there is to determine in the decomposition of coating by between solution and aluminium.
(5) surface roughness is by adopting talysurf to carry out measuring for the bar cut down from the tank applied.These are not all flattened in order to the bar measured.
(6) compatibility of propellant is determined by any structure change observed in coating, and it comprises color, transparency, expands, loses cohesive and in propellant, identified polymer segments determine by GC/MS method.
In one embodiment, E3, E4 and E5 coating as herein described also may be used for the outer surface of container.Due to the characteristic that most of aluminium alloy is intrinsic, in cleaning process by hydrocarbon from the surface of tank completely removal can cause friction high between tank.High interface friction can judge in by automatic handling device transfer pot, and high friction can disturb a glass charging (bowl-feeding) and other operations.Therefore, coating of the present invention is contributed to reducing as external surface coating the height friction between tank and tank having cleaning of the present invention to cause.As mentioned above, traditional cleaning can cause surface greasy, and cleaning described herein then only can cause metal (i.e. aluminium) exposed.Therefore, have been found that composition of the present invention can be used for by applying in advance whole container in the dilute solution that container is immersed in the coating identical with being coated in inner surface of container.
Therefore, in a specific embodiment, container can soak immediately and be used for outside and the interior surface of container simultaneously by E3, E4 and E5 coating after cleaning.First coating be diluted to 10 to 20% of its initial concentration by deionized water, provides the very thin coating reducing friction like this on surfaces externally and internally.Then container is heated to about 200 DEG C and maintain about 2-3 minute to form the crosslinked of coating.After this, these containers can store and adopt identical coating to carry out internal coat by aforesaid mode subsequently.
In another specific embodiment, coating puts on outer surface, is wherein the outer surface by roll marks (roll-printing) or gravure (gravure printing), E3, E4 or E5 coating being printed on tank.This technique is found to be particularly useful for E5 coating.This coating is applied directly outer surface, as long as it makes it rotate on the static pad being full of coating by fixing single tank, or tank is delivered to adjacent, reversely rotate and be full of the rubber rollers of coating.These rubber rollers adopt and roll across unlimited coating accumulator tank or other modes to soak full coat material.After coating, these jars are all fixed at neck and in stove, are heated to 200 DEG C and maintain 2-3 minute, most preferably are 2 minutes.The coating of outer surface can complete before or after the coating of inner surface, but preferably completed before the coating of inner surface.
In addition, the present invention is described herein is the container part applying MDI, but technique described herein also can be used for the metering valve parts cleaning and apply MDI.Namely, can be coated to provide a kind of low-viscosity surface and overcoat to prevent from contacting with aluminum metal the pollution that may bring and/or the degradation to medicine preparation with the surface of medicament contact.
In addition, the present invention also may be used for applying other base-materials, and its requirement has low separated out organic matter and has higher cohesive with the coating of subsequent applications.Adopt process of the present invention the nonrestrictive example of application member can comprise dentifrice tube, ointment tube and food pipe.Therefore, technique of the present invention can be considered for cleaning and apply medicament or ointment tube.These pipe fittings be extrusion pressing type at present and in internal coat solvent reducible coatings.Therefore material of the present invention can be used for cleaning and coating and the inner surface of medicament contact, and between preparation and the metal surface of pipe fitting, provide inert protection layer.
The pipe fitting of other products (such as toothpaste and other ingestible non-medicinal products) also can be considered to utilize technique of the present invention to carry out cleaning and applying.
Be it is expected to by the present invention, before what its other operating procedure in office, cleaning and coating step are implemented to raw material aluminum or aluminum alloy billot.Namely, before the deep-draw process manufacturing deep-draw container, can carry out cleaning and applying operation.
Although the present invention is with above-mentioned specific embodiment for reference is described, clearly, many changes, amendment and replacement can be used and not depart from the design of the present invention disclosed by this.Therefore, the present invention is intended to comprise all these changes, the amendment in the spirit and scope of claims item and replaces.The content of all patent applications be referred to herein, patent and other publications is all incorporated to herein by reference and all at this.
Claims (17)
1. cleaning is for depositing a method at least partially for the inner surface of the container of medicine or other ingestible non-medicinal products, and described method comprises the steps:
A) use contacting at least partially of aqueous cleaning composition and described inner surface of container, described aqueous cleaning composition comprises:
I) anionic surfactant, it is selected from neopelex, alkylphosphonic, alkylsulfonate, alkylbenzenesulfonate and two (2-ethylhexyl) semi-annular jade pendant sodium succinate;
Ii) emulsifying agent, it comprises sodium pyrophosphate;
Iii) optional, basic salt, it comprises sodium carbonate;
Iv) optional, buffer; And
V) optional, metal-chelator;
Wherein, cleaning temperature remains 25 DEG C to 60 DEG C, and pH value is 9 to 9.8;
B) rinse the surface of the described container cleaned, wherein rinse temperature and remain 18 DEG C to 27 DEG C;
C) optionally, the described container having cleaned described in drying and rinsed, carries out in the filtered air of wherein said drying in laminar flow drying oven.
2. the method for claim 1, described the comprising at least partly of wherein said inner surface of container is selected from aluminium, aluminium alloy and stainless material.
3. the method for claim 1, wherein said container is deep-draw aluminum alloy container.
4. the method for claim 1, the described step at least partially of wherein cleaning described inner surface of container comprises two or three continuous print cleaner bath.
5. method as claimed in claim 4, two or three wherein said continuous print cleaner bath are each naturally by ultrasonic agitation.
6. the method for claim 1, wherein said anion surfactant comprises dodecane sulfonate.
7. the method for claim 1, wherein said cleaning combination contains alkaline emulsion agent, and it is selected from the group be made up of following material: sodium phosphate, ethylenediamine tetra-acetic acid, porphines, nitrilotriacetate and ethylenediamine.
8. method as claimed in claim 7, wherein said cleaning combination contains sodium phosphate, and wherein said sodium phosphate has the function of described alkaline emulsion agent and metal-chelator.
9. method as claimed in claim 4, wherein said container contacts with described cleaning solution by described container being immersed in maintenance 1 to 5 minutes in described each cleaner bath.
10. method as claimed in claim 9, wherein said container adopts the clean cycle comprised the following steps to clean:
A) described container open end to be cleaned placed upward, while to ground, limit code in pallet, wherein said pallet is down in described each cleaner bath so that each described container is filled facing downward by edge; And
B) described pallet is cyclically made constantly to move up and down below on the surface of each cleaner bath, so that described container is repeatedly raised, turns and is full of in described each cleaner bath.
11. the method for claim 1, the surface energy of the wherein said vessel surface cleaned is between 60 to 72dyne-cm.
12. the method for claim 1, the wherein said vessel surface cleaned at least there is no that hydrocarbon remains.
13. the method for claim 1, the wherein said vessel surface cleaned contacts with moisture cross-linked coating composition.
14. 1 kinds for depositing the container cleaned of medicine or other ingestible non-medical ingredients, the inner surface at least partially of wherein said container adopts the moisture cleaning solution comprising anionic surfactant and emulsifying agent to clean, and the inner surface at least partially of wherein said container has the surface energy between 60 to 72dyne-cm and the wherein said surface cleaned at least there is no that hydrocarbon remains.
15. containers cleaned as claimed in claim 14, wherein said anionic surfactant is be selected from the group be made up of following material: neopelex, alkylphosphonic, alkylsulfonate, alkylbenzenesulfonate and two (2-ethylhexyl) semi-annular jade pendant sodium succinate.
16. containers cleaned as claimed in claim 15, wherein said anion surfactant comprises dodecane sulfonate.
17. containers cleaned as claimed in claim 14, wherein said emulsifying agent comprises sodium pyrophosphate.
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US6517940B1 (en) * | 2000-05-02 | 2003-02-11 | Ppg Industries Ohio, Inc. | Exterior-durable multi-layer composite coating compositions |
WO2003044146A1 (en) * | 2001-11-16 | 2003-05-30 | Ashland Inc. | Touchless wheel and tire cleaner and methods of application |
CN1846015A (en) * | 2003-08-29 | 2006-10-11 | 日本巴卡莱近沽株式会社 | Alkali cleaning fluid for aluminum or aluminum alloys and method of cleaning |
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US3330769A (en) * | 1964-01-23 | 1967-07-11 | Minnesota Mining & Mfg | Metal cleaning |
US5496585A (en) * | 1990-12-07 | 1996-03-05 | Golden Technologies Company, Inc. | Method for reducing volatile organic compound emissions |
US6517940B1 (en) * | 2000-05-02 | 2003-02-11 | Ppg Industries Ohio, Inc. | Exterior-durable multi-layer composite coating compositions |
WO2003044146A1 (en) * | 2001-11-16 | 2003-05-30 | Ashland Inc. | Touchless wheel and tire cleaner and methods of application |
CN1846015A (en) * | 2003-08-29 | 2006-10-11 | 日本巴卡莱近沽株式会社 | Alkali cleaning fluid for aluminum or aluminum alloys and method of cleaning |
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