DE4017153A1 - Steam-sterilisable container for medical use - consists of EVA copolymer with 5-30 per cent vinyl] acetate, made heat-resistant by treatment with very strong ionising radiation - Google Patents
Steam-sterilisable container for medical use - consists of EVA copolymer with 5-30 per cent vinyl] acetate, made heat-resistant by treatment with very strong ionising radiationInfo
- Publication number
- DE4017153A1 DE4017153A1 DE4017153A DE4017153A DE4017153A1 DE 4017153 A1 DE4017153 A1 DE 4017153A1 DE 4017153 A DE4017153 A DE 4017153A DE 4017153 A DE4017153 A DE 4017153A DE 4017153 A1 DE4017153 A1 DE 4017153A1
- Authority
- DE
- Germany
- Prior art keywords
- medical use
- container
- resistant
- steam
- treatment
- 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.)
- Ceased
Links
- 230000005855 radiation Effects 0.000 title abstract 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 title 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 title 1
- 229920002554 vinyl polymer Polymers 0.000 title 1
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 claims abstract description 7
- 239000005038 ethylene vinyl acetate Substances 0.000 claims description 8
- 229920001200 poly(ethylene-vinyl acetate) Polymers 0.000 claims description 8
- 230000005865 ionizing radiation Effects 0.000 claims description 7
- 229920001577 copolymer Polymers 0.000 claims description 2
- 239000000126 substance Substances 0.000 abstract description 3
- 238000013508 migration Methods 0.000 abstract description 2
- 230000005012 migration Effects 0.000 abstract description 2
- 239000004014 plasticizer Substances 0.000 abstract description 2
- 239000007788 liquid Substances 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 238000004659 sterilization and disinfection Methods 0.000 description 4
- DQXBYHZEEUGOBF-UHFFFAOYSA-N but-3-enoic acid;ethene Chemical compound C=C.OC(=O)CC=C DQXBYHZEEUGOBF-UHFFFAOYSA-N 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000012530 fluid Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 206010047289 Ventricular extrasystoles Diseases 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007613 environmental effect Effects 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- 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
- C08J3/00—Processes of treating or compounding macromolecular substances
- C08J3/28—Treatment by wave energy or particle radiation
-
- 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
- C08J2323/00—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers
- C08J2323/02—Characterised by the use of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Derivatives of such polymers not modified by chemical after treatment
- C08J2323/04—Homopolymers or copolymers of ethene
- C08J2323/08—Copolymers of ethene
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2203/00—Applications
- C08L2203/02—Applications for biomedical use
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/04—Homopolymers or copolymers of ethene
- C08L23/08—Copolymers of ethene
- C08L23/0846—Copolymers of ethene with unsaturated hydrocarbons containing other atoms than carbon or hydrogen atoms
- C08L23/0853—Vinylacetate
Abstract
Description
Die Erfindung betrifft Behälter für ärztlichen Gebrauch, die aus einem Äthylen-Vinylacetat-Copolymer bestehen, das 5 bis 30% gebundenen Vinylacetats enthält, und durch eine Behandlung mit Ionisierstrahlung mit einer Stärke von 30 kGy oder mehr hitzebeständig gemacht werden. Die erfindungsge mäßen Behälter besitzen dadurch bessere thermische, mecha nische und chemische Eigenschaften und können im Autoklav mit Dampf sterilisiert werden.The invention relates to containers for medical use, which consist of an ethylene-vinyl acetate copolymer, the Contains 5 to 30% bound vinyl acetate, and by a Treatment with ionizing radiation with a strength of 30 kGy or be made more heat resistant. The fiction This means that moderate containers have better thermal, mecha niche and chemical properties and can in the autoclave be sterilized with steam.
Die Anwendung von PVC zur Fertigung von Behältern für den ärztlichen Gebrauch ist allgemein bekannt: diese Behälter werden gefüllt und anschließend bei Temperaturen um 120°C im Autoklav sterilisiert.The use of PVC for the manufacture of containers for the Medical use is well known: these containers are filled and then at temperatures around 120 ° C sterilized in an autoclave.
Das PVC ist ein Material, das Gesundheitsschädlichkeitspro bleme, die im wesentlichen mit der Wanderung des Weichmachers (insbesondere DOP) in der ärztlichen Flüssigkeit zusammenhän gen und nicht minder wichtige Umweltschutzprobleme bei der Zerstörung des Polymers nach der Anwendung aufweist.PVC is a material that is harmful to health bleme, essentially with the migration of the plasticizer (especially DOP) in the medical fluid and no less important environmental protection problems in the destruction of the polymer after use.
Ebenfalls bekannt ist die Anwendung des Äthylen-Vinylacetat- Copolymers für Nährungsmittelbehälter, da der Ein satz dieses die dem PVC eigenen Schädlichkeits- und Umwelt schutzprobleme nicht aufweisenden Materials von der Offiziel len Pharmazeutik zugelassen ist.The use of ethylene vinyl acetate is also known. Copolymers for food containers, because the one This sets the PVC's harmfulness and environment protection problems of non-material from the official len pharmaceutical is approved.
Da auch in diesem Fall die Sterilisation erfoderlich ist, muß dieselbe mit Äthylenoxid oder mit γ-Strahlen niedriger Stärke erfolgen, weil das zwar wirtschaftlichere und einfa chere Verfahren der Sterilisation mit Dampf im Autoklav wegen der sehr hohen Temperatur zum Verlust der Maßbestän digkeit des Äthylen-Vinylacetats führt. Um diesen Struktur zerfall des Polymers zu vermeiden und daher die Sterilisation mit Dampf von bereits mit der ärztlichen Flüssigkeit gefüll ten Behältern auf Äthylen-Vinylacetat-Basis vornehmen zu können, hat die Anmelderin festgestellt, daß sich durch Kreuzbindung der Behälter durch Ionisierstrahlung ein Erzeug nis herstellen läßt, das hitzebeständig ist und insbesonde re unter einem Dampfstrom im Autoklav sterilisiert werden kann, ohne seine Maßbeständigkeit zu verlieren.Since sterilization is also required in this case, it must be carried out with ethylene oxide or with low-strength γ- rays, because the more economical and simpler method of steam sterilization in an autoclave due to the very high temperature leads to the loss of the dimensional stability of the ethylene Vinyl acetate leads. In order to avoid this breakdown of the polymer and therefore to be able to carry out the steam sterilization of containers already filled with the medical liquid on the basis of ethylene-vinyl acetate, the applicant has determined that a product is produced by cross-binding the containers by ionizing radiation can, which is heat-resistant and in particular re can be sterilized under a steam flow in the autoclave without losing its dimensional stability.
Der Erfindung liegt daher die Aufgabe zugrunde, Behälter für ärztlichen Gebrauch auf Basis eines Äthylen-Vinylacetat- Copolymers, das 5 bis 30% gebundenen Vinylacetats enthält, zu schaffen, die durch eine Behandlung mit Ionisierstrahlun gen mit einer Stärke von 30 kGy oder mehr hitzebeständig ge macht werden. Die so hergestellten Behälter besitzen daher bessere thermische, mechanische und chemische Eigenschaften.The invention is therefore based on the object of containers medical use based on an ethylene vinyl acetate Copolymer containing 5 to 30% bound vinyl acetate to be created by treatment with ionizing radiation heat resistant with a strength of 30 kGy or more be made. The containers produced in this way therefore have better thermal, mechanical and chemical properties.
Insbesondere erfolgt die Bestrahlung mit α-Strahlen, β-Strah len, γ-Strahlen und x-Strahlen, vorzugsweise mit β- und γ- Strahlen mit einer Stärke von mindestens 30 bis zu höchstens 250 kGy.In particular, the irradiation with α- rays, β -rays, γ- rays and x-rays, preferably with β - and γ - rays with a strength of at least 30 up to a maximum of 250 kGy.
Die erfindungsgemäßen Behälter sind gegen die hohen Tempera turen der Dampfsterilisation im Autoklav bis zu 160°C be ständig.The containers according to the invention are against the high temperature steam sterilization in an autoclave up to 160 ° C constantly.
Nachstehende Versuchsbeispiele dienen zur Erläuterung der Erfindung, ohne dieselbe jedoch irgendwie zu beschränken.The following test examples serve to explain the Invention without, however, limiting it in any way.
Ein Behälter mit 1 Liter Fassungsvermögen und 300-350 µm Wand stärke wurde durch Extrusion von Riblene-Granulatkörnern aus D-Äthylen-Vinylazetat FV2034 (Vinylacetat = etwa 14%) und anschließenden Pressen des aus dem Extruder kommenden Schlauches gefertigt.A container with 1 liter capacity and 300-350 µm wall Starch was made by extruding Riblene granules D-ethylene vinyl acetate FV2034 (vinyl acetate = about 14%) and subsequent pressing of the coming out of the extruder Hose manufactured.
Dann wurde der Behälter mit ärztlicher Flüssigkeit gefüllt und 60 Minuten lang bei 121°C im Autoklav sterilisiert.Then the container was filled with medical fluid and sterilized in an autoclave at 121 ° C for 60 minutes.
Das so behandelte Material brach mit Totalverlust der Flüssigkeit zusammen.The material treated in this way broke with total loss of Liquid together.
Der nach Beispiel 1 gefertigte Behälter wurde mit β-Strahlen mit einer Stärke von 60 kGy bestrahlt, anschließend mit der ärztlichen Flüssigkeit gefüllt und 60 Minuten lang bei 121°C im Autoklav sterilisiert. Danach war der Behälter in Form und Abmessungen vollständig unversehrt, und zwar ohne Verlust der Flüssigkeit.The container manufactured according to Example 1 was irradiated with β- rays with a strength of 60 kGy, then filled with the medical liquid and sterilized in an autoclave at 121 ° C. for 60 minutes. Afterwards, the shape and dimensions of the container were completely intact, without loss of liquid.
Claims (8)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT8920652A IT1230087B (en) | 1989-05-26 | 1989-05-26 | CONTAINERS FOR MEDICAL USE, CONSISTING OF ETHYLENE VINYL ACETATE COPOLYMERS, RESISTANT TO HIGH TEMPERATURES. |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DE4017153A1 true DE4017153A1 (en) | 1990-11-29 |
Family
ID=11170079
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DE4017153A Ceased DE4017153A1 (en) | 1989-05-26 | 1990-05-28 | Steam-sterilisable container for medical use - consists of EVA copolymer with 5-30 per cent vinyl] acetate, made heat-resistant by treatment with very strong ionising radiation |
Country Status (3)
| Country | Link |
|---|---|
| DE (1) | DE4017153A1 (en) |
| FR (1) | FR2647340A1 (en) |
| IT (1) | IT1230087B (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5683768A (en) * | 1994-12-21 | 1997-11-04 | Baxter International Inc. | Plastic formulations for platelet storage containers and the like |
| WO1999010106A1 (en) * | 1997-08-26 | 1999-03-04 | Ing. Erich Pfeiffer Gmbh | A device for discharging media |
| AT16945U1 (en) * | 2016-01-29 | 2020-12-15 | Entegris Inc | Bag structure sterilizable by gamma radiation |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3200264A1 (en) * | 1982-01-07 | 1983-07-14 | Dr. Eduard Fresenius, Chemisch-pharmazeutische Industrie KG, 6380 Bad Homburg | Physiologically acceptable bag which can be sterilised above 110 DEG C |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR1111724A (en) * | 1954-09-24 | 1956-03-05 | Centre Nat Rech Scient | Improvements to processes for crosslinking or vulcanizing plastics or rubbers by ionizing radiation |
| CH601394A5 (en) * | 1976-06-14 | 1978-07-14 | Ims Worbla Ag | Crosslinked polymer articles e.g. ski running-surface coatings |
| DE2911777A1 (en) * | 1979-03-26 | 1980-10-09 | Basf Ag | Crosslinking ethylene! polymer profiles by electron irradiation - after heating and pref. quenching before working |
| US4465487A (en) * | 1981-06-16 | 1984-08-14 | Terumo Kabushiki Kaisha | Container for medical use |
-
1989
- 1989-05-26 IT IT8920652A patent/IT1230087B/en active
-
1990
- 1990-05-23 FR FR9006459A patent/FR2647340A1/en active Pending
- 1990-05-28 DE DE4017153A patent/DE4017153A1/en not_active Ceased
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE3200264A1 (en) * | 1982-01-07 | 1983-07-14 | Dr. Eduard Fresenius, Chemisch-pharmazeutische Industrie KG, 6380 Bad Homburg | Physiologically acceptable bag which can be sterilised above 110 DEG C |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5683768A (en) * | 1994-12-21 | 1997-11-04 | Baxter International Inc. | Plastic formulations for platelet storage containers and the like |
| WO1999010106A1 (en) * | 1997-08-26 | 1999-03-04 | Ing. Erich Pfeiffer Gmbh | A device for discharging media |
| AT16945U1 (en) * | 2016-01-29 | 2020-12-15 | Entegris Inc | Bag structure sterilizable by gamma radiation |
| AT16945U8 (en) * | 2016-01-29 | 2021-04-15 | Entegris Inc | Bag structure sterilizable by gamma radiation |
Also Published As
| Publication number | Publication date |
|---|---|
| FR2647340A1 (en) | 1990-11-30 |
| IT8920652A0 (en) | 1989-05-26 |
| IT1230087B (en) | 1991-10-05 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| OP8 | Request for examination as to paragraph 44 patent law | ||
| 8131 | Rejection |