Method for manufacturing plastic container containing infusion solution which does not allow deterioration of infusion solution for long period of time

• US 4,548,605 A
• Filed: 12/07/1982
• Issued: 10/22/1985
• Est. Priority Date: 10/30/1982
• Status: Expired due to Term

• Current Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Original Assignee: Terumo Kabushiki Kaisha (Terumo Corporation)
• Inventors: Hayakawa, Naoki, Honda, Haruo, Iwamoto, Tomiyuki, Maruyama, Teppei
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Lester, Michelle N.
• Application Number:
  US06/447,689
• Time in Patent Office: 1,050 Days
• Field of Search: 604/403, 604/408, 604/410, 206/438, 206/440, 206/363, 206/370, 206/63.3, 435/253
• US Class Current: 604/410
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1462 Containers with provisions for hanging, e.g. integral adaptations of the container accessories for hanging the container A61M5/1414
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61L 2/0023 Heat
• CPC Class Codes: A61L 2/06 Hot gas
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages

Abstract

A plastic container containing an infusion solution which may not allow deterioration of the infusion solution over a long period of time, is prepared by providing a container which is made of a flexible plastic material having a heat resistance able to withstand heat of autoclaving sterilization and which holds an infusion solution containing components which may easily deteriorate upon contact with oxygen; the container is packaged with a first packaging material which consists of a plastic material having a gas permeability and a heat resistance able to withstand the heat of autoclaving sterilization. The container packaged with the first packaging material is sterilized by autoclaving in an atmosphere of saturated steam containing substantially no oxygen. The packaged and sterilized container is cooled while substantially maintaining a pressure of autoclaving sterilization by introducing an inert gas into the atmosphere. The container is further packaged with a second packaging material which has a high oxygen gas impermeability.

Claims

1. A method for manufacturing a plastic container containing an infusion solution which does not allow deterioration of the infusion solution over a long period of time, comprising the steps of:

providing a container which is made of a flexible plastic material having a heat resistance able to withstand heat of autoclaving sterilization and which holds an infusion solution containing components which may easily deteriorate upon contact with oxygen;

packaging the container hermetically within a first plastic packaging material having oxygen gas and steam permeabilities during autoclaving sterilization, and also having a heat resistance able to withstand the heat of autoclaving sterilization;

autoclaving sterilizing the container packaged in the first packaging material in an atmosphere of saturated steam containing substantially no oxygen by introducing the saturated steam through the first packaging material;

cooling the packaged and sterilized container, while substantially maintaining a pressure of autoclaving sterilization by introducing an inert gas into the atmosphere; and

further packaging the container, which is already packaged in said first packaging material, within a second packaging material which completely surrounds said first packaging material, said second packaging material having a high oxygen gas impermeability, said further packaging step being carried out without introducing an atmosphere surrounding the first packaging material into the space between the container and the first packaging material.

2. A method according to claim 1, wherein said autoclaving sterilization is performed at a temperature of 100°

to 130°

C.

3. A method according to claim 1, wherein said autoclaving sterilization is performed at a temperature of 115°

to 126°

C. and a gauge pressure of 1.2 to 2.0 kg/cm².

4. A method according to claim 1, wherein said inert gas is nitrogen gas.

5. A method according to claim 4, wherein said step of further packaging with the second packaging material is performed by vacuum packing.

6. A method according to claim 4, wherein said step of further packaging with the second packaging material is performed in a nitrogen atmosphere.

7. A method according to claim 1, wherein the container is made of polyvinyl chloride or a cross-linked ethylene-vinyl acetate copolymer.

8. A method according to claim 1, wherein the infusion solution is a high-calory fluid component.

9. A method according to claim 8, wherein the infusion solution is an amino acid fluid containing tryptophan.

10. A method according to claim 8, wherein the infusion solution is a fat emulsion.

11. A method according to claim 1, wherein the first packaging material is a member selected from the group consisting of polypropylene, high-density polyethylene, and high-density polyester.

12. A method according to claim 1, wherein the first packaging material is a member selected from the group consisting of a laminate film having a non-stretched polypropylene film as an inner layer and a biaxially stretched polypropylene film as an outer film, and a laminate film having a non-stretched polypropylene film as an inner layer, a nylon film as an intermediate film and a biaxially stretched polyethylene film as an outer film.

13. A method according to claim 1, wherein the second packaging material has an oxygen permeability of not greater than 0.1 {(cc cm/cm² see, cmHg)×

10¹² (35°

C., dry)}.

14. A method according to claim 13, wherein the second packaging material is a three-layer laminate film having a polyvinyl alcohol film as an intermediate layer.

15. A method according to claim 13, wherein the second packaging material is a laminate film consisting of a polyester film, a polypropylene film or a high-density polyethylene film with an aluminum film.

16. A method according to claim 1, wherein said packaging with the first and second packaging materials is performed by heat sealing, and the second packaging material is heat-sealed to a predetermined portion of the first packing material.

17. A method according to claim 16, wherein a first notch is formed in a heat-sealed portion of the first packing material, and a second notch is formed at a position in a heat-sealed portion of the second packing material corresponding to the first notch, thereby facilitating simultaneous opening of the first and second packing materials along the first and second notches.

18. A double packaged plastic container containing an infusion solution manufactured by a method according to claim 1, and comprising a container which is made of a flexible plastic material having a heat resistance able to withstand heat of autoclaving sterilization and which holds the infusion solution containing components which easily deteriorate upon contact with oxygen;

a first packaging material packaging the container and consisting of a plastic material having a gas permeability and a heat resistance able to withstand the heat of autoclaving sterilization; and

a second packaging material further packaging the container packaged with the first packaging material and having a high oxygen gas impermeability.

19. A method according to claim 7, wherein the cross-linked ethylene-vinyl acetate copolymer has a gel content of 50% or more and a vinyl acetate content of 10 to 20% by weight.