Sterilizable flexible peel-seal pouch package

• US 5,459,978 A
• Filed: 03/01/1993
• Issued: 10/24/1995
• Est. Priority Date: 03/01/1993
• Status: Expired due to Fees

• Current Assignee: Marshall Flexibles, LLC, Ongard Systems, Inc., Pechiney Emballage Flexible Europe, Whitesell of Carolina Incorporated
• Original Assignee: American National Can Company, Ongard Systems, Inc.
• Inventors: Johnson, Richard E., Bauer, Thomas J., Weiss, Mark E.
• Primary Examiner(s): Foster, Jimmy G.
• Application Number:
  US08/025,425
• Time in Patent Office: 967 Days
• Field of Search: 206/438-441, 206/484, 206/484.1, 206/484.2, 53/425, 383/113
• US Class Current: 53/425
• CPC Class Codes: A61B 2050/002 having adhesive means, e.g. an adhesive strip
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 50/15 Mayo stands; Tables
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61L 2/06 Hot gas
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment
• CPC Class Codes: A61L 2202/181 Flexible packaging means, e.g. permeable membranes, paper
• CPC Class Codes: B32B 2262/0253 Polyolefin fibres vinyl or acrylic copolymers B32B2262/0223 or B32B2262/0246
• CPC Class Codes: B32B 2262/0276 Polyester fibres
• CPC Class Codes: B32B 2307/31 Heat sealable
• CPC Class Codes: B32B 2307/724 Permeability to gases, adsorption
• CPC Class Codes: B32B 2307/7246 Water vapor barrier
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 5/26 another layer next to it also being fibrous or filamentary relative arrangement of fibres or filaments of different layers B32B5/12
• CPC Class Codes: B32B 7/04 Interconnection of layers
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties
• CPC Class Codes: B65B 55/02 Sterilising, e.g. of complete packages
• CPC Class Codes: B65B 55/10 by liquids or gases
• CPC Class Codes: B65D 31/02 : with laminated walls
• CPC Class Codes: B65D 75/26 : Articles or materials wholly enclosed in laminated sheets or wrapper blanks
• CPC Class Codes: B65D 75/5855 : Peelable seals

Abstract

A steam sterilizable pouch is disclosed. The pouch includes a non-woven steam-permeable bottom web. A multi-layer intermediate web is bonded to the bottom web. The multi-layer web is substantially steam impermeable, except for a perforated steam-permeable region. The intermediate web includes top and bottom layers. A steam-impermeable top web is bonded by a first line heat seal to the top layer of the intermediate web. A cavity having a heat sealable access opening is located between the top web and the top layer. At least a portion of the first line heat seal is peelable after steam sterilization of the pouch at 270° F., the peel strength being from 3/4 to 5 pounds per inch. The bonding of the intermediate web to the bottom web is by a second line heat seal that is located peripherally outside of the perforated steam permeable region of the intermediate web.

Claims

1. A steam-sterilizable pouch comprising:

a steam-permeable non-woven bottom web;

a multilayer intermediate web superposed with and bonded to said bottom web, said intermediate web being substantially steam-impermeable, having a perforated region to permit passage of steam, and having a bottom layer and a top layer bonded thereto;

a steam impermeable top web superposed with and bonded to the top layer of said intermediate web by a first line heat seal, said first line heat seal defining limits of a cavity between said top web and said intermediate web for receiving an object to be sterilized, at least one area of said package being free of said first line heat seal, said seal-free area forming an access opening for inserting an item to be sterilized into said cavity, said access opening being sealable such that, when sealed, the sealed access opening forms with said first line heat seal a continuous steam-impervious seal enclosing said cavity, at least a portion of said first line heat seal being a peelable seal which, after steam sterilization of the pouch at a temperature of 270°

F., has a peel strength of from 3/4 to 5 pounds per inch and is reliably sealed such that the shelf life of a sealed sterilized package is at least 30 days, said peel seal portion of said first line heat seal extending a distance such that, when peeled open, the contents of the cavity are readily removable from said cavity;

said intermediate web being bonded to said bottom web by a second line heat seal peripherally outside the perforated steam-permeable region of said intermediate web such that, when the pouch is sealed, steam can penetrate into said cavity only after passing through said bottom web and then through the perforated region of the intermediate web.

2. A steam-sterilizable pouch according to claim 1 wherein said intermediate web is a coextrusion.

3. A steam-sterilizable pouch according to claim 1 wherein said top web is a lamination.

4. A steam-sterilizable pouch according to claim 1 wherein said first line heat seal is positioned directly above said second line heat seal.

5. A steam-sterilizable pouch according to claim 1 wherein said pouch is rectilinear, wherein said first and second line heat seals extend in marginal areas on three sides of the package, and wherein said access opening is located on the fourth side of the package.

6. A steam-sterilizable pouch according to claim 1 wherein said pouch further comprises means for sealing said access opening.

7. A steam-sterilizable pouch according to claim 6 wherein said sealing means comprises an adhesive strip.

8. A steam-sterilizable pouch according to claim 5 wherein the top intermediate and bottom webs are positioned with three sides in coincident, wherein the intermediate web is larger than said top web such that its fourth side extends beyond the fourth side of said top web, and wherein the bottom web is larger than the intermediate web such that its fourth side extends beyond the fourth side of said intermediate web.

9. A steam-sterilizable pouch according to claim 8 wherein the fourth side of said intermediate web is sealed to the bottom web whereby the intermediate web is sealed to the bottom web by a continuous seal peripherally outside said perforated area.

10. A steam-sterilizable pouch according to claim 9 wherein said fourth side seal comprises an adhesive seal.

11. A steam-sterilizable pouch according to claim 8 wherein said pouch further comprises means for sealing the access opening between said intermediate and top webs.

12. A steam-sterilizable pouch according to claim 11 wherein said sealing means comprises an adhesive strip extending across the upper surface of the intermediate web in the portion of said intermediate web which extends beyond the fourth side of said top web.

13. A steam-sterilizable pouch according to claim 12 wherein said pouch further comprises a fold line extending across the pouch at a location outside the fourth side of said top web whereby said access opening is sealable by folding the pouch along the fold line to position the adhesive strip on said access opening.

14. A steam-sterilizable pouch according to claim 12 wherein said adhesive comprises a pressure sensitive adhesive.

15. A steam-sterilizable pouch according to claim 12 wherein said adhesive strip further extends across the upper surface of the bottom web in the portion of said bottom web which extends beyond the fourth side of said intermediate web whereby the adhesive strip seals the fourth side of the intermediate web to the bottom web whereby the intermediate web is sealed to the bottom web by a continuous seal peripherally outside said perforated area.

16. A steam-sterilizable pouch according to claim 1 wherein said bottom web comprises a non-woven polyester.

17. A steam-sterilizable pouch according to claim 1 or 16 wherein the bottom layer of said intermediate web comprises polypropylene or a propylene copolymer.

18. A steam-sterilizable pouch according to claim 1 wherein the top web comprises a top layer which comprises a polyester or nylon and a bottom layer which comprises polypropylene or a propylene copolymer.

19. A steam-sterilizable pouch according to claim 1 or 18 wherein the top layer of said intermediate web comprises PIB-modified HDPE or a blend thereof with up to 90% polypropylene or a propylene copolymer.

20. A steam-sterilizable pouch according to claim 1 wherein said bottom web comprises spunlaced polyester, the bottom layer of said intermediate web comprises polypropylene or a propylene copolymer, the top layer of said intermediate web comprises PIB-modified HDPE or a blend thereof with up to 90% polypropylene or propylene copolymer, the bottom layer of said top web comprises polypropylene or propylene copolymer, and the top layer of said top web comprises polyester or nylon.

21. A steam-sterilizable pouch according to claim 20 wherein said intermediate web comprises a tie layer between its top and bottom layers said tie layer comprising PIB-modified HDPE, rubber-modified polypropylene, or a propylene copolymer.

22. A method of steam sterilizing an object which comprises:

(a) providing a pouch which comprises;

a steam-permeable bottom web;

a multilayer intermediate web superposed with and bonded to said bottom web, said intermediate web being substantially steam-impermeable, having a perforated region to permit passage of steam, and having a bottom layer and a top layer bonded thereto;

a steam impermeable top web superposed with and bonded to the top layer of said intermediate web by a first line heat seal, said first line heat seal defining limits of a cavity between said top web and said intermediate web for receiving an object to be sterilized, at least one area of said package being free of said first line heat seal, said seal-free area forming an access opening for inserting an item to be sterilized into said cavity, said access opening being sealable such that, when sealed, the sealed access opening forms with said first line heat seal a continuous steam-impervious seal enclosing said cavity, at least a portion of said first line heat seal being a peelable seal which, after steam sterilization of the pouch at a temperature of 270°

F., has a peel strength of from 3/4 to 5 pounds per inch and is reliably sealed such that the shelf life of a sealed sterilized package is at least 30 days, said peel seal portion of said first line heat seal extending a distance such that, when peeled open, the contents of the cavity are readily removable from said cavity;

said intermediate web being bonded to said bottom web by a second line heat seal peripherally outside the perforated steam-permeable region of said intermediate web such that, when the pouch is sealed, steam can penetrate into said cavity only after passing through said bottom web and then through the perforated region of the intermediate web, said second line heat seal being a permanent fiber tearing seal;

(b) placing an object to be sterilized in the cavity of the pouch;

(c) sealing said pouch such that the object to be sterilized is sealed in said cavity and such that steam can penetrate into said cavity only after passing through the bottom web and then through the perforated region of the intermediate web;

(d) and subjecting the sealed pouch to steam sterilization at a temperature of at about 270°

F. for a time sufficient to sterilize said object.

23. A method according to claim 22 wherein steam sterilization is carried out for at least 3 minutes.

24. A method according to claim 23 wherein steam sterilization is carried out for from 3-10 minutes.

25. A method according to claim 22 wherein the pouch is rectilinear and where said first and second line heat seals extend in marginal areas on three sides of the package and wherein said access opening is located on the fourth side of the package.

26. A method according to claim 22 wherein said pouch comprises a pressure sensitive adhesive strip and wherein step (c) is carried out by applying said adhesive strip across said access opening.

27. A method according to claim 26 wherein stop (c) is carried out by folding the pouch such that the adhesive strip is applied across said access opening.

28. A method according to claim 22 wherein said bottom web comprises a non-woven polyester.

29. A method according to claim 22 or 28 wherein said the bottom layer of said intermediate web comprises polypropylene or a propylene copolymer.

30. A method according to claim 22 wherein the top web comprises a top layer which comprises a polyester or nylon and a bottom layer which comprises polypropylene or a propylene copolymer.

31. A method according to claim 22 or 30 wherein the top layer of said intermediate web comprises PIB-modified HDPE or a blend thereof with up to 90% polypropylene or a propylene copolymer.

32. A method according to claim 22 wherein said bottom web comprises spun bonded polyester, the bottom layer of said intermediate web comprises polypropylene or a propylene copolymer, the top layer of said intermediate web comprises PIB-modified HDPE or a blend thereof with up to 90% polypropylene or propylene copolymer, the bottom layer of said top web comprises polypropylene or propylene copolymer, and the top layer of said top web comprises polyester or nylon.

33. A method according to claim 22 wherein said intermediate web comprises a tie layer between its top and bottom layers, said tie layer comprising PIB-modified HDPE, rubber-modified polypropylene, or a propylene copolymer.