Polymeric syringe body and stopper

• US 20020139088A1
• Filed: 03/08/2001
• Published: 10/03/2002
• Est. Priority Date: 03/08/2001
• Status: Abandoned Application

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Darvasi, John, Falzone, John, Gillum, Amy W., Barnato, Margaret J., McClelland, Deborah, Kamienski, James, Sandford, Craig, Gliniecki, Robert, Woodworth, Archie, Raghavan, Neervalur V.
• Application Number:
  US09/801,864
• Publication Number:
  US 20020139088A1
• Time in Patent Office: Days
• US Class Current: 53/426
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61M 5/001 Apparatus specially adapted for cleaning or sterilising syringes or needles
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence

Abstract

A syringe having a syringe body of a norbornene and ethylene copolymer, the body defining a chamber for containing water and having an opening, a plunger seal of a halobutyl-based elastomer sealing the opening; and wherein the syringe meets all requirements of the United States Pharmocopoeia for sterile water for injection.

Claims

1. A flowable materials container comprising:

a body of a cyclic olefin containing polymer or a bridged polycyclic olefin containing polymer, the body defining a chamber to contain flowable materials, the chamber having an opening;

an elastomeric component attached to the body and providing a seal of the chamber; and

wherein the body when filled with 1 ml of water suitable for injection and sealed with the elastomeric component and stored for 3 months generates less than 4 ppm of chlorides in the water.

2. The container of claim 1 wherein the body is a syringe body.

3. The container of claim 2 wherein the elastomeric component is a plunger seal.

4. The container of claim 1 wherein the elastomeric component is a synthetic rubber.

5. The container of claim 4 wherein the synthetic rubber is selected from the group consisting of styrene-butadiene copolymers, acrylonitrile-butadiene copolymers, neoprenes, butyl rubbers, polysulfide elastomers, urethane rubbers, stereo rubbers, ethylene-propylene elastomers.

6. The container of claim 5 wherein the synthetic rubber has halogen substitutents.

7. The container of claim 6 wherein the synthetic rubber is a halogenated butyl rubber.

8. The container of claim 7 wherein the synthetic rubber is a chlorobutyl-based elastomer.

9. A flowable materials container comprising:

a body of a homopolymer, copolymer or terpolymer of norbornene, the body defining a chamber to contain flowable materials, the chamber having an opening; and

an elastomeric component providing a seal of the opening and the component being a butyl rubber.

10. The container of claim 9 wherein the body is a homopolymer of norbornene.

11. The container of claim 9 wherein the body is a copolymer of norbornene.

12. The container of claim 11 wherein the copolymer of norbornene has a comonomer selected from the group consisting of α

-olefins having from 2-10 carbons, aromatic hydrocarbons, cyclic olefins and bridged polycyclic olefins.

13. The container of claim 12 wherein the comonomer is ethylene.

14. The container of claim 9 wherein the butyl rubber is halogenated.

15. The container of claim 14 wherein the component is a chlorobutyl elastomer.

16. The container of claim 15 wherein the component is essentially latex free.

17. The container of claim 15 wherein the component is 100% latex free.

19. The syringe of claim 18 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 70°

C. to about 200°

C.

20. The syringe of claim 18 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 75°

C. to about 150°

.

21. The syringe of claim 18 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 76°

C. to about 149°

C.

18. A syringe comprising:

a syringe body of a norbornene and ethylene copolymer, the body defining a chamber for containing water and having an opening; and

a plunger seal of a halobutyl based elastomer sealing the opening.

22. A syringe comprising:

a syringe body of a norbornene and ethylene copolymer, the body defining a chamber for containing water and having an opening;

a plunger seal of a halobutyl based elastomer sealing the opening; and

wherein the syringe meets all requirements of the United States Pharmocopoeia for sterile water for injection.

24. The syringe of claim 23 wherein the plunger seal is a chlorobutyl based elastomer.

25. The syringe of claim 24 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 70°

C. to about 200°

C.

26. The syringe of claim 24 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 75°

C. to about 150°

.

27. The syringe of claim 24 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 76°

C. to about 149°

C.

28. The syringe of claim 24 wherein the norbonrene and ethylene copolymer is capable of being sterilized in an autoclave at 121°

C.

30. The method of claim 29 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 70°

C. to about 200°

C.

31. The method of claim 29 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 75°

C. to about 150°

.

32. The method of claim 29 wherein the norbornene and ethylene copolymer has a heat deflection temperature at 0.45 Mpa from about 76°

C. to about 149°

C.

33. The method of claim 32 wherein the halobutyl based elastomer is a chlorobutyl-based elastomer.

34. The method of claim 29 wherein the transferring step comprises the step of:

transferring the sterilized syringe body from a sterilizing station to the sterile environment wherein the sterilized syringe body is exposed to a sterile ambient atmosphere.

23. A sterile water for injection syringe comprising:

a syringe body of a norbornene and ethylene copolymer, the body defining a chamber containing water and having an opening;

a plunger seal of a halobutyl based elastomer forming a fluid tight seal of the opening; and

wherein the syringe meets all requirements of the United States Pharmocopoeia for sterile water for injection.

29. A method for filling a syringe comprising the steps of:

providing a syringe body of a norbornene and ethylene copolymer and having an opening;

sterilizing the syringe body to define a sterilized syringe body;

transferring the sterilized syringe body to a sterile environment while maintaining the sterility of the sterilized syringe body;

filling the sterilized syringe body with an appropriate quantity of sterile water for injection;

sealing the opening with an elastomeric component of a halobutyl based elastomer to define a sterile water for injection syringe; and

wherein the sterile water for injection syringe meets the requirements of the United States Pharmocopoeia for sterile water for injection.

35. A method for filling a syringe comprising the steps of:

providing a syringe body of a norbornene and ethylene copolymer and having an opening;

sterilizing the syringe body to define a sterilized syringe body;

transferring the sterilized syringe body to a sterile environment while maintaining the sterility of the sterilized syringe body;

immediately filling the sterilized syringe body with an appropriate quantity of sterile water for injection;

sealing the opening with an elastomeric component of a halobutyl-based elastomer to define a sterile water for injection syringe; and

wherein the sterile water for injection syringe meets the requirements of the United States Pharmocopoeia for sterile water for injection.