Package units for medical purposes

• US 5,129,894 A
• Filed: 08/05/1988
• Issued: 07/14/1992
• Est. Priority Date: 08/06/1987
• Status: Expired due to Term

• Current Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius AG (Fresenius SE & Co. KGaA)
• Inventors: Koenig, Jurgen, Sommermeyer, Klaus, Herbert, Reinhold, Cech, Franz
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/229,012
• Time in Patent Office: 1,439 Days
• Field of Search: 604/408, 604/409, 604/410, 604/403
• US Class Current: 604/408
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• 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 27/32 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

Abstract

The present invention describes package units for medical purposes, in particular for receiving and/or storing sterilizable preparations for parenteral uses or dialysis solutions, comprising a container having at least one discharge spout and consisting of polyamide 66 or a laminate of polyamide 66 sheet and polyolefin sheet, the polyolefin sheet being disposed on the side facing the liquid to be stored and the sheet of polyamide 66 being disposed on the outside and the two sheets being bonded together in usual manner by means of an adhesive. The package units may further comprise an inner container or an outer container. The package unit is made in that a container having at least one discharge spout is made from polyamide 66 or the aforementioned laminate, said container filled with the liquid to be stored, then sealed and sterilized and possibly subsequently surrounded after cooling and drying with an outer container of polymeric material. Package units according to the invention may also be made in that from a polymeric material an inner container having at least one discharge spout is made, said container filled with the liquid to be stored, sealed, then surrounded with an outer container of polyamide 66 or a laminate of polyamide 66 sheet and polyolefin sheet, the polyolefin sheet being disposed at the side of the laminate facing the inner container and the sheet of polyamide 66 of the laminate representing the outer sheet, and thereafter sterilized.

Claims

1. A package unit for medical purposes, in particular for receiving or storing a sterilizable liquid preparation for parenteral use or dialysis solutions, the package unit comprising

a first container consisting of a polymer laminate material which comprises on the side facing the liquid preparation a polyolefin sheet and on the other side a sheet of polyamide 66, the two sheets bonded together by means of an adhesive,

a second container outside of and surrounding the first container, the second container bearing sealingly on, without bonding to, the polymeric laminate material of the first container, and

the package unit having at least one discharge spout for discharging the liquid preparation therefrom.

2. The package unit according to claim 1, wherein the polyolefin sheet is a polyethylene or polypropylene sheet.

3. The package unit according to claim 1, wherein the polyolefin sheet and the sheet of polyamide 66 are bonded together by means of a polyurethane adhesive.

4. The package unit according to claim 1, wherein the polymeric laminate material is up to 0.2 mm thick, the polyolefin sheet having a thickness of 50 to 100 μ

m and the sheet of polyamide 66 a thickness of 20 to 100 μ

m.

5. The package unit according to claim 1, wherein the outer container consists of a polymeric material.

6. The package unit according to claim 5, wherein the outer container consists of a polymeric laminate.

7. The package unit according to claim 1, comprising also a third container in which the liquid preparation resides and having an exterior surface and having an interior with which the at least one discharge spout communicates the third container enclosed and surrounded by the first container.

8. The package unit according to claim 7, wherein the polyolefin sheet faces, without bonding to, the exterior surface of the third container.

9. A package unit according to claim 8, wherein the third container consists of polyolefin, polyesters or copolymers thereof.

10. A package unit for receiving or storing a sterilizable liquid preparation for parenteral use or dialysis solutions, the package unit comprising

a first container consisting of a polymeric laminate material which comprises on the side facing the liquid preparation a polyolefin sheet and on the other side a sheet of polyamide 66, the two sheets bonded together by means of an adhesive.

a second container inside of and surrounded by the first container, the polymeric laminate material of the first container, facing, without bonding to, the second container, and

the package unit having at least one discharge spout for discharging the liquid preparation therefrom.

11. A method for making a package unit for receiving or storing a sterilizable liquid preparation for parenteral use or dialysis solutions, the method comprising

making a first container consisting of a polymeric laminate material which comprises on the side facing the liquid preparation a polyolefin sheet and on the other side a sheet of polyamide 66, by bonding the two sheets together by means of an adhesive,

filling said first container with the liquid preparation,

then sealing and sterilizing said first container,

disposing said first container in a second container and

sealing the first container in the second container so that the second container bears sealingly on, without bonding to, the first container.

12. The method according to claim 11, wherein the polyolefin sheet is polyethylene foil.

13. The method according to claim 11, wherein said first container is sterilized at a temperature of about 120°

C. and an excess pressure of about 2.2 bar.

14. The method according to claim 11, wherein said first container after sterilizing is allowed to cool and dry and is thereafter disposed in said second container.

15. The method according to claim 14, wherein said second container is made from a polymeric material.

16. A method for making a package unit for receiving and storing a sterilizable liquid preparation for parenteral use or dialysis solutions, the method comprising

making an inner container and an outer container,

making the outer container from a polymeric material including polyamide 66, the polymeric material including a laminate of polyolefin sheet and an outer sheet of polyamide 66, the polyolefin sheet being arranged at the side of the laminate facing the liquid preparation,

making the inner container from a polymeric material,

filling the inner container with the liquid preparation,

sealing and thereafter surrounding the inner container with the outer container, the outer container bearing sealingly on, without bonding to, the inner container, and

emplacing at least one discharge spout in the package unit for discharging the liquid preparation therefrom.

17. The method according to claim 16 wherein the polyolefin sheet is a polyethylene sheet.

18. The method according to claim 16 wherein the inner container is made from polyolefin, polyester or copolymers thereof.

19. The method according to claim 16, wherein the polymeric material for the outer container is a laminate of a polyolefin sheet and a sheet of polyamide 66 which are bonded together with an adhesive, the polyolefin sheet arranged at the side of the laminate facing the inner container and the sheet of polyamide 66 of the laminate being the outer sheet.

20. A method for making a package unit for medical purposes for receiving or storing sterilizable liquid preparations for parenteral use or dialysis solutions, the method comprising

making a first container from a polymeric laminate material which comprises on the side facing the liquid preparation a polyolefin sheet and on the other side a sheet of polyamide 66, by bonding the two sheets together by means of an adhesive,

disposing a second container within said first container,

filling said second container with the liquid preparation,

then sealing and sterilizing said second container,

sealing the second container in the first container so that the first container lies on, without bonding to, the second container, and

emplacing at least one discharge spout in the package unit for discharging the liquid preparation therefrom.