NO840110L - STERILIZABLE FILM MATERIALS FOR PRIMARY PACKAGING OF Aqueous MEDICAL SOLUTIONS - Google Patents
STERILIZABLE FILM MATERIALS FOR PRIMARY PACKAGING OF Aqueous MEDICAL SOLUTIONSInfo
- Publication number
- NO840110L NO840110L NO840110A NO840110A NO840110L NO 840110 L NO840110 L NO 840110L NO 840110 A NO840110 A NO 840110A NO 840110 A NO840110 A NO 840110A NO 840110 L NO840110 L NO 840110L
- Authority
- NO
- Norway
- Prior art keywords
- foil
- aliphatic
- material according
- foil material
- polyamide
- Prior art date
Links
- 239000000463 material Substances 0.000 title claims description 20
- 238000009516 primary packaging Methods 0.000 title claims description 5
- 239000008155 medical solution Substances 0.000 title 1
- 239000011888 foil Substances 0.000 claims description 41
- 239000004800 polyvinyl chloride Substances 0.000 claims description 12
- 229920000915 polyvinyl chloride Polymers 0.000 claims description 12
- 238000004519 manufacturing process Methods 0.000 claims description 8
- -1 polypropylene Polymers 0.000 claims description 7
- 239000004952 Polyamide Substances 0.000 claims description 6
- 125000001931 aliphatic group Chemical group 0.000 claims description 6
- 229920001400 block copolymer Polymers 0.000 claims description 6
- 229920002647 polyamide Polymers 0.000 claims description 6
- 239000007864 aqueous solution Substances 0.000 claims description 5
- 125000004432 carbon atom Chemical group C* 0.000 claims description 5
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims description 4
- 239000012815 thermoplastic material Substances 0.000 claims description 4
- 239000004743 Polypropylene Substances 0.000 claims description 3
- 150000002334 glycols Chemical class 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 claims description 2
- 239000005977 Ethylene Substances 0.000 claims description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 2
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 claims description 2
- 229920003231 aliphatic polyamide Polymers 0.000 claims description 2
- 229920002301 cellulose acetate Polymers 0.000 claims description 2
- 150000004985 diamines Chemical class 0.000 claims description 2
- 229920001198 elastomeric copolymer Polymers 0.000 claims description 2
- 229920001903 high density polyethylene Polymers 0.000 claims description 2
- 239000004700 high-density polyethylene Substances 0.000 claims description 2
- 150000002430 hydrocarbons Chemical group 0.000 claims description 2
- 229920000554 ionomer Polymers 0.000 claims description 2
- 229920000092 linear low density polyethylene Polymers 0.000 claims description 2
- 239000004707 linear low-density polyethylene Substances 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- 229920001707 polybutylene terephthalate Polymers 0.000 claims description 2
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 2
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 2
- 229920000642 polymer Polymers 0.000 claims description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 2
- 229920001169 thermoplastic Polymers 0.000 claims description 2
- 239000004416 thermosoftening plastic Substances 0.000 claims description 2
- 229910052799 carbon Inorganic materials 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 1
- 239000002131 composite material Substances 0.000 claims 1
- 230000004888 barrier function Effects 0.000 description 7
- 239000004014 plasticizer Substances 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 229920002614 Polyether block amide Polymers 0.000 description 5
- 238000001125 extrusion Methods 0.000 description 5
- 229920001328 Polyvinylidene chloride Polymers 0.000 description 4
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 4
- 239000001301 oxygen Substances 0.000 description 4
- 229910052760 oxygen Inorganic materials 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 239000003978 infusion fluid Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 229920003023 plastic Polymers 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 239000005033 polyvinylidene chloride Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- 238000007664 blowing Methods 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000004721 Polyphenylene oxide Substances 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 239000012611 container material Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 229910000041 hydrogen chloride Inorganic materials 0.000 description 1
- IXCSERBJSXMMFS-UHFFFAOYSA-N hydrogen chloride Substances Cl.Cl IXCSERBJSXMMFS-UHFFFAOYSA-N 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 238000001802 infusion Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 229920000570 polyether Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 239000005060 rubber Substances 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 238000004056 waste incineration Methods 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J5/00—Manufacture of articles or shaped materials containing macromolecular substances
- C08J5/18—Manufacture of films or sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G69/00—Macromolecular compounds obtained by reactions forming a carboxylic amide link in the main chain of the macromolecule
- C08G69/44—Polyester-amides
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
- C08J2377/00—Characterised by the use of polyamides obtained by reactions forming a carboxylic amide link in the main chain; Derivatives of such polymers
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Polymers & Plastics (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Manufacturing & Machinery (AREA)
- Organic Chemistry (AREA)
- Materials Engineering (AREA)
- Materials For Medical Uses (AREA)
- Laminated Bodies (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Polyamides (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Polyesters Or Polycarbonates (AREA)
- Packages (AREA)
- Bag Frames (AREA)
Description
Foreliggende oppfinnelse angår steriliserbarefoliematerialerThe present invention relates to sterilizable foil materials
og deres anvendelse for primærforpakninger av vandige opp-løsninger på det medisinske området. and their use for primary packaging of aqueous solutions in the medical field.
Infusjons- og overføringsoppløsninger tilbys vanligvis i glassflasker, kunststoffbeholdere eller posebeholdere. På grunn av de mangler som følger med apparatmaterialet (energibetingede høye fremstillingsomkostninger, relativt høy beholdervekt, manglende fallfasthet og problematisk disponering av tomme glassflasker) har man gått mer og mer over til å anvende beholdere av kunststoff ved lagring henholdsvis overføring av vandige oppløsninger på det medisinske området. Derved til- Infusion and transfer solutions are usually provided in glass bottles, plastic containers or pouch containers. Due to the shortcomings that come with the device material (energy-related high manufacturing costs, relatively high container weight, lack of fall resistance and problematic disposal of empty glass bottles), people have increasingly switched to using plastic containers for the storage or transfer of aqueous solutions in the medical field the area. Thereby to-
byr posesystemer av myknerholdige polyvinylkloridfolier ganske avgjørende fordeler som gjør deres anvendelse på markedet til nå uten konkurranse: fremstilling av myknerholdige PVC-poser kan skje med høy frekvens uten at det oppstår problemer ved innsveising av tilførsels- og utløpsledningssystemer som like-ledes er fremstilt av PVC, slik som f.eks. fyllrør, innstik-ningsstusser med membran og injeksjonskanaler med kautsjuk-membraner. De således oppnådde poser oppviser en høy fleksi-bilitet, er i stor utstrekning transparente og rives ikke opp selv når de faller i bakken i fylt tilstand. bag systems of plasticizer-containing polyvinyl chloride foils offer quite decisive advantages that make their use on the market so far without competition: the production of plasticizer-containing PVC bags can take place with a high frequency without problems arising when welding in supply and outlet pipe systems that are also made of PVC , such as e.g. filler pipes, insertion nozzles with membrane and injection channels with rubber membranes. The bags thus obtained show a high degree of flexibility, are largely transparent and do not tear open even when they fall to the ground in a filled state.
Nettopp på det medisinske området er imidlertid anvendelsenHowever, the application is precisely in the medical field
av med mykner mykgjort polyvinylklorid for foliematerialer henholdsvis de nevnte posesystemer ikke helt uomstridt. Man må imidlertid regne med at poseinnholdet, spesielt fett- og blodserumholdige oppløsninger løser ut mykneren, som regel di-2-etylheksylftalat, fra foliematerialet og således blir iblandet fremmedforbindelser. Videre trer de virksomme stoffer i spesielle oppløsninger i vekselvirkning med myk- of with softener softened polyvinyl chloride for foil materials or the aforementioned bag systems are not entirely uncontroversial. However, it must be expected that the contents of the bag, especially solutions containing fat and blood serum, dissolve the plasticizer, usually di-2-ethylhexyl phthalate, from the foil material and foreign compounds are thus mixed in. Furthermore, the active substances in special solutions interact with soft-
PVC, f.eks. ved adsorpsjon.PVC, e.g. by adsorption.
Vanligvis blir poser av myk-PVC dampsterilisert ved 110°C iUsually bags made of soft PVC are steam sterilized at 110°C i
40 minutter eller ved 121°C i 20 minutter. Umiddelbart etter dampsteriliseringen er posematerialet melkeaktig slik at inn-holdet kun i utilstrekkelig grad kan bedømmes. Først etter 40 minutes or at 121°C for 20 minutes. Immediately after the steam sterilisation, the bag material is milky so that the content can only be assessed to an insufficient extent. Only after
lengre lagring blir transparensen bedre.the longer the storage, the better the transparency.
En av de innvendinger som skyldes de tiltagende miljøbeskym-ringer er at de tomme myk-PVC-poser ved disponering i søppel-forbrenningsanlegg avgir giftige hydrogenkloriddamper og at anvendelsen må innskrenkes av disse grunner. One of the objections due to the growing environmental concerns is that the empty soft PVC bags emit toxic hydrogen chloride vapors when disposed of in waste incineration plants and that their use must be restricted for these reasons.
Foreliggende oppfinnelse har til oppgave å finne et alterna-tivt materiale til det markedsvanlige og med myknere mykgjorte polyvinylklorid for infusjonsoppløsningsposer. Det skal dermed finnes et materiale som ikke lenger oppviser de beskrevne mangler til myk-PVC og som samtidig bringer myk-PVC<1>S fordeler inn i et nytt konsept. The purpose of the present invention is to find an alternative material to the market-standard polyvinyl chloride softened with plasticizers for infusion solution bags. There must therefore be a material which no longer exhibits the described shortcomings of soft PVC and which at the same time brings the advantages of soft PVC<1>S into a new concept.
I henhold til dette angår foreliggende oppfinnelse steriliserbare foliematerialer for primærforpakninger av vandige opp-løsninger på det medisinske området som består av en termoplastisk blokkkopolymer, nemlig en polyeter-ester-amid-blokkkopolymer med den generelle formel (i) Accordingly, the present invention relates to sterilizable foil materials for primary packaging of aqueous solutions in the medical field which consist of a thermoplastic block copolymer, namely a polyether-ester-amide block copolymer of the general formula (i)
der A er en lineær mettet alifatisk polyamidsekvens, dannet av et laktan eller en animosyre med en hydrokarbonkjedelengde på 4 til 14 karbonatomer eller av en alifatisk CS til C12 dikarboksylsyre og et C6 til C9 diamin in nærvær av en C4 til C20 alifatisk dikarboksylsyre som kjedelengdebegrenser, hvorved polyamid har en midlere molekylvekt mellom 300 og 15000; where A is a linear saturated aliphatic polyamide sequence, formed from a lactan or an animo acid with a hydrocarbon chain length of 4 to 14 carbon atoms or from an aliphatic CS to C12 dicarboxylic acid and a C6 to C9 diamine in the presence of a C4 to C20 aliphatic dicarboxylic acid as chain length limiter, wherein the polyamide has an average molecular weight between 300 and 15,000;
B betyr en polyoksyalkylensekvens dannet av lineære eller forgrenede alifatiske polyoksyalkylenglykoler, blandinger derav eller cyklopolyeterderivater derav, hvorved polyoksyalkylen-glykolet har en midlere molekylvekt på 6000; og n er antallet tilbakevendende polymerenheter, som er så stor at polyeter-ester-amid-blokkopolymeren har en grenseviskositet på 0,8 til 2,05. B means a polyoxyalkylene sequence formed from linear or branched aliphatic polyoxyalkylene glycols, mixtures thereof or cyclopolyether derivatives thereof, whereby the polyoxyalkylene glycol has an average molecular weight of 6000; and n is the number of repeating polymer units, which is such that the polyether-ester-amide block copolymer has an intrinsic viscosity of 0.8 to 2.05.
De nevnte polyeter-ester-amid-blokkopolymerer er gjenstandThe mentioned polyether-ester-amide block copolymers are subject
for US-PS 4 331 786.for US-PS 4,331,786.
Materialet med den angitte generelle formel (I) oppviser iThe material of the indicated general formula (I) exhibits i
sin kjemiske struktur en lineær regelmessig kjede av stive polyamid- og fleksible polyetersegmenter. its chemical structure a linear regular chain of rigid polyamide and flexible polyether segments.
Foliene ifølge oppfinnelsen inneholder ingen mykner i den betydning myk-PVC inneholder en vanlig ytre mykner. The foils according to the invention contain no plasticizer in the sense that soft PVC contains a normal external plasticizer.
Foliene av polyeter blokkamid kan fremstilles som flatefolier eller som blåsefolier. Dette skjer ved at polyeterblokkamid-granulat fylles i en ekstruder og føres ut på kjent måte gjennom egnede dyser. Umiddelbart etter dysen blir foliematerialet i ennå plastisk tilstand blåst opp ved hjelp av luft til flere ganger utløpsdiameteren og deretter presset flat ved hjelp av et valsepar eller dreiet flatt. For fremstilling av flatfolier skjærer man så de langs siden forløpende brettekanter av, for fremstilling av blåsefolier kan det således fremstilte slangebånd forarbeides direkte videre. The foils of polyether blockamide can be produced as flat foils or as blown foils. This happens by filling polyetherblockamide granules in an extruder and feeding them out in a known manner through suitable nozzles. Immediately after the die, the foil material in its still plastic state is blown up using air to several times the outlet diameter and then pressed flat using a pair of rollers or turned flat. For the production of flat foils, the folding edges running along the side are then cut off, for the production of blown foils, the hose band thus produced can be further processed directly.
Av hygieniske grunner og på grunn av den forurensningsfrie videre bearbeiding er blåsefolier å foretrekke for anvendelse på det medisinske området. For hygienic reasons and because of the contamination-free further processing, blown films are preferable for use in the medical field.
Oppblåsingsprosessen muliggjør at det kan oppnås meget store slanger med små veggtykkelser uten at dysen behøver å være så stor og måtte ha en spesielt smal og dermed ømfintlig spalt som ved den senere folieslange. Ved blåseekstruderingsmetoden kan det således fremstilles en monoslangefolie med en vegg-tykkelse på 100 til 300 ym og fortrinnsvis 150 til 200 ym. The inflation process makes it possible to obtain very large hoses with small wall thicknesses without the nozzle needing to be as large and having to have a particularly narrow and thus delicate gap as with the later foil hose. With the blow extrusion method, a mono-tube foil can thus be produced with a wall thickness of 100 to 300 ym and preferably 150 to 200 ym.
Folier av de nevnte materialer og med de nevnte veggtykkelser lar seg på meget enkel måte ved hjelp av varmekontakt eller varmeimpuls sveise til poser, fortrinnsvis ved hjelp av høy-frekvensmetoden. En pose av denne folie med en vandig infu-sjonsoppløsning som innhold kan uten problemer steriliseres i mottrykksautoklaver ved 121°C og en belastningstid på 20 minutter uten hjelpemidler og uten termisk deformering. Transparensen for foliematerialet blir derved ikke dårligere. Foils of the aforementioned materials and with the aforementioned wall thicknesses can be welded into bags in a very simple way using heat contact or heat impulse, preferably using the high-frequency method. A bag of this foil with an aqueous infusion solution as content can be sterilized without problems in a back pressure autoclave at 121°C and a loading time of 20 minutes without aids and without thermal deformation. The transparency of the foil material does not thereby deteriorate.
Den steriliserte pose oppviser fremragende mekaniske egenskaper. Ved en prøve på fallfastheten i henhold til DIN 58 363, del 15, punkt 4.1.4 ble det funnet en meget fallfasthet. The sterilized bag exhibits excellent mechanical properties. In a drop resistance test according to DIN 58 363, part 15, point 4.1.4, a very high drop resistance was found.
Ved siden av fremstillingen av monofolier som beskrevet ovenfor er det også mulig å fremstille flersjiktsfolier. Til dette egner seg tallrike andre termoplastiske og for folie-fremstilling egnede materialer slik som polypropylen, høyden-sitetspolyetylen, polyvinylalkohol, polyetylentereftalat, polybutylentereftalat, lineær-lav-densitets-polyetylen-ionomer, polyamid, elastomere kopolymerer av etylen og vinylacetat, celluloseacetat eller polyvinylidenklorid. Hensikten med slike flersjiktsfolier som består av et laminat av polyeter-blokkamid med de nevnte termoplastiske materialer er fremstilling av folieposer med gass- og vanndampsperrer. In addition to the production of mono foils as described above, it is also possible to produce multi-layer foils. Numerous other thermoplastic materials suitable for foil production are suitable for this, such as polypropylene, high-density polyethylene, polyvinyl alcohol, polyethylene terephthalate, polybutylene terephthalate, linear low-density polyethylene ionomers, polyamide, elastomeric copolymers of ethylene and vinyl acetate, cellulose acetate or polyvinylidene chloride. . The purpose of such multi-layer foils which consist of a laminate of polyether-blockamide with the aforementioned thermoplastic materials is the production of foil bags with gas and water vapor barriers.
Således kunne det for å redusere oksygen- eller vanndampgjennom-trengeligheten fremstilles en folie ved koekstruderings-blåse-metoden med tre sjikt av polyeterblokkamid/polyvinylidendi-klorid/polyeterblokkamid. Thus, in order to reduce the oxygen or water vapor permeability, a foil could be produced by the coextrusion-blowing method with three layers of polyetherblockamide/polyvinylidene dichloride/polyetherblockamide.
Oppfinnelsen skal forklares nærmere under henvisning til led-sagende eksempler. The invention shall be explained in more detail with reference to relevant examples.
Eksempel 1.Example 1.
I et folieblåseanlegg ble det ved hjelp av det beskrevne kopoly-eteresteramid blåst en monoslangefolie. In a foil blowing plant, a mono-tube foil was blown with the help of the described copolyetheresteramide.
Ekstruden hadde en skrue med diameter 60 mm og en lengde påThe extruder had a screw with a diameter of 60 mm and a length of
25 d. Forbundet med den var en ringdyse med diameter 200 mm. 25 d. Connected to it was a ring nozzle with a diameter of 200 mm.
Ekstrusjonsbetingelser: Extrusion conditions:
Folien ble deretter bearbeidet ved høyfrekvenssveising til The foil was then processed by high-frequency welding to
500 ml posebeholdere. Samtidig ble det innsveiset posetil-løps- og utløpssystemer. Disse systemer var som folien fremstilt av kopolyeter-ester-amid og var fremstilt ved sprøyte-støping og ved slangeekstrudering. 500 ml bag containers. At the same time, postil inlet and outlet systems were welded in. These systems, like the foil, were produced from copolyether-ester-amide and were produced by injection molding and by tube extrusion.
Den således oppnådde pose ble fylt med en vandig infusjons-oppløsning (0,9%-ig fysiologisk koksaltoppløsning) og damp-destilert ved 120°C i 20 minutter uten hjelpemidler i mot-trykksautoklave. Til slutt ble den steriliserte pose bedømt mot en ikke-sterilisert pose. The bag thus obtained was filled with an aqueous infusion solution (0.9% physiological saline solution) and steam-distilled at 120°C for 20 minutes without aids in a counter-pressure autoclave. Finally, the sterilized bag was judged against a non-sterilized bag.
Transparensen var like god som før steriliseringen. Deforma-sjonsfenomener på grunn av temperaturbelastning kunne ikke fastslås på beholdermaterialet. The transparency was as good as before the sterilization. Deformation phenomena due to temperature stress could not be determined on the container material.
I henhold til DIN 58 363, del 15, punkt 4.1.4, ble det jo gjennomført en fallprøve med poser. Alle fem poser besto denne prøve. In accordance with DIN 58 363, part 15, point 4.1.4, a drop test with bags was carried out. All five bags passed this test.
Riktignok var sperreegenskapene mot vanndamp og oksygen ennå ikke tilfredsstillende.Ytterligere poser ble deretter sveiset inn i en dampsteriliserbar transparent omhyllingspose. Som omhyllingsmateriale ble det anvendt kommersielt tilgjengelige folier slik som f.eks. polyamid-polyetylen (50 ym/75 ym) og polyamid-polypropylen (70 pm/75 pm). Derved ga polyamidsjiktet en tilstrekkelig oksygensperring og polyolefinsjiktet en tilstrekkelig vanndampsperring. Man passet i forsøkene på at om-hyllingsposen lå mest mulig tett mot oppløsningsposen. Ved hjelp av vakuum kunne dette oppnås. Admittedly, the barrier properties against water vapor and oxygen were not yet satisfactory. Additional bags were then sealed into a steam-sterilizable transparent overwrap bag. Commercially available foils such as e.g. polyamide-polyethylene (50 ym/75 ym) and polyamide-polypropylene (70 pm/75 pm). Thereby, the polyamide layer provided a sufficient oxygen barrier and the polyolefin layer a sufficient water vapor barrier. Care was taken in the experiments that the re-shuffling bag lay as close as possible to the dissolution bag. With the help of a vacuum, this could be achieved.
Eksempel 2.Example 2.
En ytterligere utførelsesform for forbedring av vanndamp- og oksygensperreegenskapene for folien ifølge oppfinnelsen er den direkte kombinasjon med ett eller flere sperresjikt. Ved ko-ekstrudering ble det blåst en tresjikts slangefolie. Planlagt var en folie med følgende oppbygning: kopolyeter-ester-amid/polyvinylidenklorid/kopolyeter-ester-amid. A further embodiment for improving the water vapor and oxygen barrier properties of the foil according to the invention is the direct combination with one or more barrier layers. In co-extrusion, a three-layer hose foil was blown. The plan was a film with the following structure: copolyether-ester-amide/polyvinylidene chloride/copolyether-ester-amide.
Maskinbetingelsene ved ekstruderingen ble valgt som i eksempelThe machine conditions for the extrusion were chosen as in the example
1, dog ble det foretatt følgende endringer:1, however, the following changes were made:
3 stoffer ble ført sammen i en ringdyse ved hjelp av 3 ekstrudere 3 substances were brought together in a ring nozzle by means of 3 extruders
Ekstruderne 1 og 2 tilmåtet kopolyeter-ester-amid og den 3. ekstruder matet polyvinylidenklorid til ringdysen. Extruders 1 and 2 fed copolyether ester amide and the 3rd extruder fed polyvinylidene chloride to the ring die.
Man oppnådde en transparent slangefolie med følgende sjikt-tykkelser: A transparent hose foil was obtained with the following layer thicknesses:
Av denne folie ble det fremstilt poser med lukkesystemer ved høyfrekvenssveising og disse bedømt ved de samme prøver som i eksempel 1. From this foil, bags with closure systems were produced by high-frequency welding and these were judged by the same tests as in example 1.
De fylt poser viste etter dampsterilisering ved 121°C i/20 minutter de samme gode resultater. I motsetning til mono- slangefolien ble det i tillegg målt gode gass- og vanndamp-sperreegenskaper. The filled bags showed the same good results after steam sterilization at 121°C for 20 minutes. In contrast to the mono hose foil, good gas and water vapor barrier properties were also measured.
Claims (6)
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE19833300944 DE3300944A1 (en) | 1983-01-13 | 1983-01-13 | STERILIZABLE FILM MATERIALS FOR PRIMARY PACKAGING OF AQUEOUS SOLUTIONS IN THE MEDICAL AREA |
Publications (1)
Publication Number | Publication Date |
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NO840110L true NO840110L (en) | 1984-07-16 |
Family
ID=6188209
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
NO840110A NO840110L (en) | 1983-01-13 | 1984-01-12 | STERILIZABLE FILM MATERIALS FOR PRIMARY PACKAGING OF Aqueous MEDICAL SOLUTIONS |
Country Status (8)
Country | Link |
---|---|
EP (1) | EP0116288A3 (en) |
JP (1) | JPS59140224A (en) |
BR (1) | BR8400132A (en) |
DE (1) | DE3300944A1 (en) |
DK (1) | DK9884A (en) |
ES (1) | ES528818A0 (en) |
FI (1) | FI840092A (en) |
NO (1) | NO840110L (en) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS61155426A (en) * | 1984-12-28 | 1986-07-15 | Res Dev Corp Of Japan | Antithrombotic synthetic polymer |
JPH0657237B2 (en) * | 1985-04-26 | 1994-08-03 | 凸版印刷株式会社 | Packaging material for radiation sterilization |
JPH021281A (en) * | 1988-03-10 | 1990-01-05 | Yasuo Iwai | Sterilizable container |
FR2639644A1 (en) * | 1988-11-25 | 1990-06-01 | Atochem | THERMOPLASTIC ELASTOMERIC FILM PERMEABLE TO WATER VAPOR BASED ON POLYETHERESTERAMIDE, PROCESS FOR PRODUCING THE SAME AND ARTICLES COMPRISING SUCH FILM |
JP2960520B2 (en) * | 1990-10-09 | 1999-10-06 | 株式会社細川洋行 | Barrier infusion packaging material |
JP2960519B2 (en) * | 1990-10-09 | 1999-10-06 | 株式会社細川洋行 | Barrier infusion packaging material |
US5529821A (en) * | 1992-06-29 | 1996-06-25 | Terumo Kabushiki Kaisha | Container for storing blood or blood component |
EP0577493B1 (en) * | 1992-06-29 | 2000-12-27 | Terumo Kabushiki Kaisha | Container for storing blood or blood component |
DE69631449T2 (en) * | 1995-04-11 | 2004-09-16 | Atofina | Packaging made of polymers with polyamide and polyether blocks to keep products fresh |
DE19645276A1 (en) | 1996-11-02 | 1998-05-07 | Kalle Nalo Gmbh | Hand-fillable sausage casing based on polyamide |
US8179324B2 (en) | 2009-02-03 | 2012-05-15 | Research In Motion Limited | Multiple input, multiple output antenna for handheld communication devices |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2466478B2 (en) * | 1979-10-02 | 1986-03-14 | Ato Chimie | PROCESS FOR THE PREPARATION OF ELASTOMERIC ALIPHATIC COPOLYETHERESTERAMIDES |
JPS57206447A (en) * | 1981-06-12 | 1982-12-17 | Terumo Corp | Plastic container receiving liquid drug pasturized with high pressure steam and production thereof |
-
1983
- 1983-01-13 DE DE19833300944 patent/DE3300944A1/en not_active Withdrawn
-
1984
- 1984-01-10 DK DK9884A patent/DK9884A/en not_active Application Discontinuation
- 1984-01-11 FI FI840092A patent/FI840092A/en not_active Application Discontinuation
- 1984-01-11 EP EP84100240A patent/EP0116288A3/en not_active Withdrawn
- 1984-01-12 ES ES528818A patent/ES528818A0/en active Granted
- 1984-01-12 NO NO840110A patent/NO840110L/en unknown
- 1984-01-12 JP JP59004237A patent/JPS59140224A/en active Pending
- 1984-01-12 BR BR8400132A patent/BR8400132A/en unknown
Also Published As
Publication number | Publication date |
---|---|
DK9884A (en) | 1984-07-14 |
FI840092A (en) | 1984-07-14 |
ES8503608A1 (en) | 1985-03-01 |
EP0116288A3 (en) | 1986-10-08 |
EP0116288A2 (en) | 1984-08-22 |
FI840092A0 (en) | 1984-01-11 |
DK9884D0 (en) | 1984-01-10 |
ES528818A0 (en) | 1985-03-01 |
DE3300944A1 (en) | 1984-07-19 |
BR8400132A (en) | 1984-08-21 |
JPS59140224A (en) | 1984-08-11 |
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