DK1875889T3 - Opbevaringslegeme til medicinsk væskebeholder og fremgangsmåde til fremstilling deraf - Google Patents
Opbevaringslegeme til medicinsk væskebeholder og fremgangsmåde til fremstilling deraf Download PDFInfo
- Publication number
- DK1875889T3 DK1875889T3 DK06745438.9T DK06745438T DK1875889T3 DK 1875889 T3 DK1875889 T3 DK 1875889T3 DK 06745438 T DK06745438 T DK 06745438T DK 1875889 T3 DK1875889 T3 DK 1875889T3
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- Prior art keywords
- drug solution
- plastic
- container
- solution container
- oxygen
- Prior art date
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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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
-
- 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
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/1379—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/1379—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
- Y10T428/1383—Vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit is sandwiched between layers [continuous layer]
Landscapes
- Health & Medical Sciences (AREA)
- Hematology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Packages (AREA)
- Wrappers (AREA)
Claims (16)
1. Lægemiddelopløsningsbeholderemballage, omfattende: en plastbeholder til lægemiddelsopløsning (10), i hvilken en lægemiddelopløsning opbevares og forsegles, og som er dampsteriliseret eller varmtvandssteriliseret; en oxygenopfanger; og en udvendig pose med en oxygenbarriereegenskab til at opbevare og forsegle plastbeholderen til lægemiddelopløsning og oxygenopfangeren, hvor en plast, som danner plastbeholderen til lægemiddelopløsning (10), har en oxygengasoverførselshastighed på under 200cm3/m2-24h-atm ved en temperatur på 25°C og en luftfugtighed på 60%RH inden for tolv timer efter dampsterilisering eller varmtvandssterilisering, og har en oxygengasoverførselshastighed på under 100cm3/m2-24h-atm ved en temperatur på 25°C og en luftfugtighed på 60%RH, når oxygengasoverførselshastigheden er i en konstant tilstand.
2. Lægemiddelopløsningsbeholderemballage ifølge krav 1, hvor dampsteriliseringen er en fremgangsmåde til opvarmning af plastbeholderen til lægemiddelsopløsning (10) i 10 til 60 minutter under en inertgasatmosfære af en temperatur på mellem 100 og 121°C og i en dampmættet tilstand.
3. Lægemiddelopløsningsbeholderemballage ifølge krav 1, hvor den plast, som danner plastbeholderen til lægemiddelopløsning (10) er en flerlagsfilm med et forseglingslag (1), der er dannet af polyolefin-baseret plast ved en indre overflade af plastbeholderen til lægemiddelopløsning (10), et beskyttelseslag (5) på den udvendige overflade af plastbeholderen til lægemiddelopløsning (10), og et mellemliggende lag (4), der er dannet af en polyol-baseret plast mellem forseglingslaget (1) og beskyttelseslaget (5).
4. Lægemiddelopløsningsbeholderemballage ifølge krav 3, hvor den polyol-baserede plast, som danner det mellemliggende lag (4), er en ethylen-vinylalkohol-copolymer med et indhold af ethylen på mellem 10 og 45 mol%.
5. Lægemiddelopløsningsbeholderemballage ifølge krav 3, hvor en vanddampoverførselshastighed af helheden af lagene af flerlagsfilm, som er anbragt ved den udvendige overfladeside af plastbeholderen til lægemiddelop løsning (10) i forhold til det mellemliggende lag (4), er på mellem 1 og 50g/m2-24h ved en temperatur på 25°C og en luftfugtighed på 90%RH.
6. Lægemiddelopløsningsbeholderemballage ifølge krav 3, hvor flerlagsfilmen yderligere har lag med lav vandabsorption (3), der dannes af en plast med lav vandabsorption, mellem forseglingslaget (1) og det mellemliggende lag (4).
7. Lægemiddelopløsningsbeholderemballage ifølge krav 6, hvor plasten med lav vandabsorption er en cycloolefinpolymer.
8. Lægemiddelopløsningsbeholderemballage ifølge krav 1, hvor den plast, som danner plastbeholderen til lægemiddelopløsning (10), har en oxygen-gasoverførselshastighed på mellem 500 og 1000cm3/m2-24h-atm ved en temperatur på 25°C og en luftfugtighed på 60%RH inden for tolv timer efter at være udsat for dampsterilisering eller varmtvandssterilisering.
9. Lægemiddelopløsningsbeholderemballage ifølge krav 1, hvor den plast, som danner plastbeholderen til lægemiddelopløsning (10) har en oxygen-gasoverførselshastighed på mellem 0,5 og 70cm3/m2-24hatm ved en temperatur på 25°C og en luftfugtighed på 60%RH, når oxygengasoverførselsha-stigheden er i en konstant tilstand.
10. Lægemiddelopløsningsbeholderemballage ifølge krav 1, hvor plastbeholderen til lægemiddelopløsning (10) er dannet af en sådan plast, som kræver mindst to dage for oxygengasoverførselshastigheden til at opnå den konstante tilstand efter dampsterilisering eller varmtvandssterilisering.
11. Lægemiddelopløsningsbeholderemballage ifølge krav 1, hvor en lægemiddelopløsning, som opbevares og forsegles i plastbeholderen til lægemiddelopløsning (10), er en lægemiddelopløsning, som indeholder en let oxideret substans.
12. Lægemiddelopløsningsbeholderemballage ifølge krav 1, hvor den udvendige lomme har en vanddampoverførselshastighed på mellem 0,5 og 30g/m2-24h ved en temperatur på 25°C og en luftfugtighed på 90%RH.
13. Fremgangsmåde til fremstilling af en lægemiddelopløsningsbeholderem-ballage, hvor efter fremstilling af en lægemiddelopløsning, der opbevares og forsegles i en plastbeholder til lægemiddelsopløsning (10), der dannes af en plast, som har en oxygengasoverførselshastighed på under 200 cm3/m2-24h-atm ved en temperatur på 25°C og en luftfugtighed på 60%RH inden for tolv timer efter at være udsat for dampsterilisering eller varmt-vandssterilisering, og som har en oxygengasoverførselshastighed på under 100cm3/m2-24h- atm ved en temperatur på 25°C og en luftfugtighed på 60%RH, når oxygengasoverførselshastigheden er i en konstant tilstand, bliver plastbeholderen til lægemiddelsopløsning (10) dampsteriliseret eller varmtvandssteriliseret, og derefter vil den dampsteriliserede eller varmt-vandssteriliserede plastbeholder til lægemiddelsopløsning (10) og en oxygenopfanger opbevares og forsegles i en udvendig lomme med en oxygen-barriereegenskab.
14. Fremgangsmåde til fremstilling afen lægemiddelopløsningsbeholderem-ballage ifølge krav 13, hvor dampsteriliseringen er en fremgangsmåde til opvarmning af plastbeholderen til lægemiddelsopløsning (10) i 10 til 60 minutter under en inertgasatmosfære af en temperatur på mellem 100 og 121°C og i en dampmættet tilstand.
15. Fremgangsmåde til fremstilling afen lægemiddelopløsningsbeholderem-ballage ifølge krav 13, hvor den udvendige lomme har en vanddampoverførselshastighed på mellem 0,5 og 30g/m2-24h ved en temperatur på 25°C og en luftfugtighed på 90%RH.
16. Fremgangsmåde til fremstilling af en lægemiddelopløsningsbeholderem-ballage ifølge krav 13, hvor et rum mellem plastbeholderen til lægemiddelsopløsning (10) og den udvendige lomme erstattes med en inertgas, inden plastbeholderen til lægemiddelsopløsning (10) og oxygenopfangeren opbevares og forsegles i den udvendige lomme.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2005132624 | 2005-04-28 | ||
| PCT/JP2006/308206 WO2006118034A1 (ja) | 2005-04-28 | 2006-04-19 | 薬液容器収容体およびその製造方法 |
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| DK1875889T3 true DK1875889T3 (da) | 2014-12-08 |
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| DK06745438.9T DK1875889T3 (da) | 2005-04-28 | 2006-04-19 | Opbevaringslegeme til medicinsk væskebeholder og fremgangsmåde til fremstilling deraf |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US8465819B2 (da) |
| EP (1) | EP1875889B1 (da) |
| JP (2) | JP4939405B2 (da) |
| KR (1) | KR101231965B1 (da) |
| CN (1) | CN101180026B (da) |
| AU (1) | AU2006241992B8 (da) |
| CA (1) | CA2604611C (da) |
| DK (1) | DK1875889T3 (da) |
| ES (1) | ES2529741T3 (da) |
| PT (1) | PT1875889E (da) |
| TW (1) | TWI299988B (da) |
| WO (1) | WO2006118034A1 (da) |
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-
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- 2006-04-19 EP EP06745438.9A patent/EP1875889B1/en active Active
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- 2006-04-19 AU AU2006241992A patent/AU2006241992B8/en not_active Ceased
- 2006-04-19 ES ES06745438.9T patent/ES2529741T3/es active Active
- 2006-04-19 JP JP2007514626A patent/JP4939405B2/ja active Active
- 2006-04-19 CN CN2006800173080A patent/CN101180026B/zh active Active
- 2006-04-19 DK DK06745438.9T patent/DK1875889T3/da active
- 2006-04-19 PT PT67454389T patent/PT1875889E/pt unknown
- 2006-04-19 US US11/911,644 patent/US8465819B2/en active Active
- 2006-04-19 KR KR1020077026574A patent/KR101231965B1/ko active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| AU2006241992B8 (en) | 2011-11-17 |
| JPWO2006118034A1 (ja) | 2008-12-18 |
| TW200716079A (en) | 2007-05-01 |
| US8465819B2 (en) | 2013-06-18 |
| JP5167392B2 (ja) | 2013-03-21 |
| KR101231965B1 (ko) | 2013-02-08 |
| JP4939405B2 (ja) | 2012-05-23 |
| CA2604611C (en) | 2013-10-22 |
| CN101180026B (zh) | 2012-02-22 |
| CA2604611A1 (en) | 2006-11-09 |
| EP1875889B1 (en) | 2014-11-26 |
| US20090032426A1 (en) | 2009-02-05 |
| EP1875889A4 (en) | 2013-11-27 |
| EP1875889A1 (en) | 2008-01-09 |
| WO2006118034A1 (ja) | 2006-11-09 |
| TWI299988B (en) | 2008-08-21 |
| KR20080003423A (ko) | 2008-01-07 |
| JP2011212505A (ja) | 2011-10-27 |
| ES2529741T3 (es) | 2015-02-25 |
| AU2006241992A1 (en) | 2006-11-09 |
| AU2006241992B2 (en) | 2011-11-03 |
| PT1875889E (pt) | 2015-01-14 |
| CN101180026A (zh) | 2008-05-14 |
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