Film laminate with gas barrier for sterile flexible containers

• US 4,692,361 A
• Filed: 09/28/1984
• Issued: 09/08/1987
• Est. Priority Date: 09/28/1984
• Status: Expired due to Term

• Current Assignee: Baxter International Inc., Fujimori Kogyo Company Limited
• Original Assignee: Baxter Travenol Laboratories Incorporated (Baxter International Inc.)
• Inventors: Hori, Yasuhiko, Imano, Shigeki, Nagata, Masanori, Johnston, William D., Webster, R. D., Czuba, Leonard
• Primary Examiner(s): RYAN, PATRICK J
• Application Number:
  US06/655,493
• Time in Patent Office: 1,075 Days
• Field of Search: 428/423.5, 428/424.6, 428/424.8, 428/475.8, 428/35, 428/36, 383/113, 604/408
• US Class Current: 428/35.4
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: B32B 2307/518 bi-axially
• CPC Class Codes: B32B 2307/72 Density
• CPC Class Codes: B32B 2307/7242 Non-permeable
• CPC Class Codes: B32B 2323/046 LDPE, i.e. low density polyethylene
• CPC Class Codes: B32B 2327/06 PVC, i.e. polyvinylchloride
• CPC Class Codes: B32B 2375/00 Polyureas; Polyurethanes
• CPC Class Codes: B32B 2377/00 Polyamides
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/18 characterised by the use of special additives
• CPC Class Codes: B32B 27/32 comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/34 comprising polyamides
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: Y10T 428/1341 Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit

Abstract

A film laminate for flexible containers capable of containing a product to be maintained and removed under sterile conditions. The film laminate having an outside layer of linear low density polyethylene, a gas barrier layer, a core layer of polyamide, and an inside layer of linear low density polyethylene. The layers being bonded together by a polyurethane adhesive.

Claims

1. A laminate film structure having sufficient flexibility, strength, heat sealability, and slip properties for producing on a packaging machine flexible containers having fitments attached thereto and capable of containing a liquid to be maintained under sterile conditions comprising:

an inner layer constructed from polyethylene, the inner layer having a thickness of approximately 40 to 100 microns;

a gas barrier layer having a thickness of approximately 25 to 50 microns;

a core layer constructed from biaxially oriented polyamide, the core layer having a thickness of approximately 10 to 40 microns;

an outer layer constructed from polyethylene and having a thickness of approximately 40 to 100 microns, the outer layer including a slip agent and having a coefficient of friction of approximately 0.2 to about 0.4; and

three layers of an aliphatic polyurethane bonding the layers together.

2. The film structure of claim 1 wherein the polyethylene is a linear low density polyethylene.

3. The film structure of claim 2 wherein the polyethylene copolymer contains approximately 2% to 10% by weight 1-hexene.

4. The film structure of claim 1 wherein the gas barrier is a polyvinylidene chloride.

5. The film structure of claim 2 wherein the density of the linear low density polyethylene copolymer layers is approximately 0.91 to about 0.94 grams/cubic centimeters.

6. The film structure of claim 2 wherein the linear low density polyethylene layers include the following additives:

an antioxidant;

a stabilizer;

a slip agent; and

an antiblocking agent.

7. The film structure of claim 1 wherein the aliphatic polyurethane adhesive has a thickness of between approximately 1 to about 10 microns.

8. The film structure of claim 7 wherein the bond strength of the polyethylene layers to the gas barrier layer and core layer is at least 500 gms/inch of force to delaminate.

9. The film structure of claim 1 wherein the thickness of the film structure is approximately 155 to about 230 microns.

33. The flexible container of claim 1 wherein the biaxially oriented nylon includes a slip agent.

10. A film structure having sufficient flexibility, strength, heat sealability, and slip properties for producing on a packaging machine a flexible container for containing a liquid to be administered into a patient'"'"'s body comprising:

a layer of a linear low density polyethylene copolymer for forming an outside layer of the flexible container;

a layer of polyvinylidene chloride for forming a gas barrier layer;

a layer of biaxially oriented nylon for forming a core layer of the flexible container;

a layer of a linear low density polyethylene copolymer for forming an inside layer of the flexible container; and

the layers being bonded by a polyurethane adhesive.

11. The film structure of claim 10 wherein the polyethylene layers that comprise the outside and inside layers of the flexible container have a density of between approximately 0.91 to about 0.94 grams/cubic centimeters.

12. The film structure of claim 10 wherein the outside layer includes approximately 0.05% to about 0.15% by weight of a fatty acid amide containing 8 to 22 carbon atoms.

13. The film structure of claim 12 wherein the fatty acid amide is an oleic amide.

14. The film structure of claim 10 wherein the outside layer has a coefficient of friction of between 0.2 to 0.4.

15. The film structure of claim 10 wherein the polyurethane adhesive comprises a polyester-urethanediol resin.

16. The film structure of claim 15 wherein the layers are bonded to each other at a peel strength of at least 500 gms/inch of force to delaminate.

17. The film structure of claim 10 wherein the linear low density polyethylene copolymers that comprise the outside and inside layers of the flexible container include:

an antioxidant;

a slip agent;

a stabilizer; and

an antiblocking agent.

18. The film structure of claim 17 wherein:

the antioxidant is selected from the group consisting of tetrakis[methylene-3-(3'"'"'5'"'"'-di-tert-butyl-4'"'"'-hydroxy phenyl)propionate]methane, n-octadecyl-beta-(4'"'"'-hydroxy-3'"'"',5'"'"'-di-tert-butylphenyl)propionate, butylated hydroxytoluene, Ethyl antioxidant 330, and tetrakis(2,4-di-tert-butylphenyl)-4,4'"'"'-biphenylene disphosphonite;

the stabilizer is calcium stearate; and

the anti-blocking agent is selected from the group consisting of magnesium hydroxide, aluminum hydroxide, and magnesium silicate.

19. The film structure of claim 10 wherein:

the outside layer has a thickness of approximately 40 to about 100 microns;

the inside layer has a thickness of approximatly 40 to about 100 microns;

the gas barrier layer has a thickness of approximately 25 to about 50 microns; and

the core layer has a thickness of approximately 10 to about 40 microns.

20. The film structure of claim 19 wherein the thickness of the film structure is approximately 155 to about 230 microns.

21. The film structure of claim 10 wherein the polyvinylidene chloride is SARAN.

22. A flexible container capable of containing under sterile conditions a fluid or solid to be stored at temperatures above 0°

C. having a body portion with opposed, peripherally sealed walls forming the container the walls being constructed from a laminate comprising;

an outside layer constructed from linear low density polyethylene;

a gas barrier layer constructed from polyvinylidene chloride;

a core layer constructed from biaxially oriented nylon;

an inside layer constructed from linear low density polyethylene; and

three layers of a urethane adhesive for bonding the outside, vapor barrier, core, and inside layers.

23. The flexible container of claim 22 wherein the outside layer and inside layer have a density of approximately 0.91 to about 0.94 grams/cubic centimeters.

24. The flexible container of claim 22 wherein the film laminate has a thickness of approximately 150 to about 200 microns.

25. The flexible container of claim 22 wherein the outside layer contains a slip agent.

26. The flexible container of claim 22 wherein the outside layer has a coefficient of friction of approximately 0.2 to about 0.4.

27. The flexible container of claim 22 wherein:

the outside layer has a thickness of approximately 40 to about 100 microns;

the inside layer has a thickness of approximately 40 to about 100 microns;

the gas barrier has a thickness of approximately 25 to about 50 microns; and

the core layer has a thickness of approximately 10 to 40 microns.

28. The flexible container of claim 27 wherein the outside and inside layer have approximately the same thickness.

29. The flexible container of claim 27 wherein each of the layers of urethane adhesive have a thickness of approximately 1 to about 10 microns.

30. The flexible container of claim 28 wherein the layers are bonded to each other at a peel strength of at least 500 gms/inch of force to delaminate.

31. The flexible container of claim 22 including a fitment heat sealed to the outside layer.

32. The flexible container of claim 22 wherein a portion of the inside layer is heat sealed together to create the walls of the flexible container.

34. The flexible container of claim 22 wherein the gas barrier layer is constructed from SARAN.