# US 2016/0355289 A1 · Methods for packaging and sterilizing elastomeric articles and packaged elastomeric articles produced thereby

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- Number: US 2016/0355289 A1
- Document ID: US20160355289A1
- Status: Published application
- Kind: A1
- Application number: 15/172,733
- Filed: 2016-06-03
- Published: 2016-12-08
- Earliest claimed: 2010-01-22
- Assignees: Allegiance Corporation
- Applicants: Allegiance Corporation
- Inventors: Seong Fong Chen; Wei Cheong Wong
- Web page: https://patentgrep.com/patent/US20160355289A1

## CPC

- B65B 55/16: by irradiation
- B32B 7/06: permitting easy separation
- B32B 25/08: of synthetic resin
- B32B 27/08: of synthetic resin
- B32B 27/32: comprising polyolefins {(comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30)}
- B65B 5/04: Packaging single articles
- B65B 7/164: {Securing by heat-sealing}
- B65B 9/045: {for single articles, e.g. tablets}
- B65B 31/02: Filling, closing, or filling and closing, containers {or wrappers} in chambers maintained under vacuum or superatmospheric pressure or containing a special atmosphere, e.g. of inert gas
- B65B 51/10: Applying or generating heat or pressure or combinations thereof {(welding of plastics per se B29C65/02; closing plastic tube ends in general B29C57/10)}
- B65B 63/02: for compressing or compacting articles or materials prior to wrapping or insertion in containers or receptacles
- B65D 65/38: Packaging materials of special type or form
- B65D 81/2007: {under vacuum}
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

The present invention relates generally to methods of sterilizing elastomeric articles in a manner that prevents and/or reduces degradation to the articles, particularly degradation that may be caused and/or accelerated by sterilization techniques such as gamma irradiation, x-ray irradiation, and electron-beam processing. The methods include packaging the elastomeric articles in order to improve their resistance to degradation. In certain aspects of the invention, packaged elastomeric articles, optionally containing one or more antidegradants, such as antioxidant and/or antiozonant compounds, are also provided. The methods of providing degradation-resistant elastomeric articles in accordance with the present invention may also be used to reduce the occurrence of cracking and discoloration in elastomeric articles, regardless of whether they are subjected to sterilization.

## Claims

### Claim at position 1

1-36. (canceled)

### Claim 37

A packaged elastomeric article produced by a method comprising:
providing an elastomeric article comprising an elastomer and one or more antidegradants;
placing the elastomeric article in a package comprising a low-oxygen-permeable material;
exposing the package to a vacuum to form a reduced-oxygen environment inside the package;
sealing the package to provide the elastomeric article within the reduced-oxygen environment inside the package; and
sterilizing the elastomeric article provided within the reduced-oxygen environment inside the package using a sterilization process comprising radiation sterilization.

### Claim 38 (depends on 37)

The packaged elastomeric article of claim 37, wherein the sterilization process is selected from the group consisting of gamma irradiation, x-ray irradiation, and electron beam processing.

### Claim 39 (depends on 37)

The packaged elastomeric article of claim 37, wherein the elastomer comprises synthetic polyisoprene.

### Claim 40 (depends on 37)

The packaged elastomeric article of claim 37, wherein the one or more antidegradants comprises an antiozonant.

### Claim 41 (depends on 40)

The packaged elastomeric article of claim 40, wherein the antiozonant comprises an anionic wax emulsion.

### Claim 42 (depends on 37)

The packaged elastomeric article of claim 37, wherein the one or more antidegradants comprises an antioxidant.

### Claim 43 (depends on 42)

The packaged elastomeric article of claim 42, wherein the antioxidant comprises a butylated reaction product of p-cresol and dicyclopentadiene.

### Claim 44 (depends on 37)

The packaged elastomeric article of claim 37, wherein the reduced-oxygen environment comprises less than about 20 cm3 of trapped oxygen.

### Claim 45 (depends on 37)

The packaged elastomeric article of claim 37, wherein the reduced-oxygen environment contains less than about 16 cm3 of trapped oxygen.

### Claim 46 (depends on 37)

The packaged elastomeric article of claim 37, wherein the reduced-oxygen environment contains less than about 14 cm3 of trapped oxygen.

### Claim 47 (depends on 37)

The packaged elastomeric article of claim 37, wherein the package has a volume of about 280 cm3 or less.

### Claim 48 (depends on 37)

The packaged elastomeric article of claim 37, wherein the package has a volume of about 225 cm3 or less.

### Claim 49 (depends on 37)

The packaged elastomeric article of claim 37, wherein the package has a volume of about 335 cm3 or less.

### Claim 50 (depends on 37)

The packaged elastomeric article of claim 37, wherein the vacuum has a pressure of less than 320 mbar.

### Claim 51 (depends on 37)

The packaged elastomeric article of claim 37, wherein the elastomeric article has a thickness of 0.22 mm or less.

### Claim 52 (depends on 37)

The packaged elastomeric article of claim 37, wherein the elastomeric article exhibits reduced degradation compared to a comparison elastomeric article that does not comprise an antiozonant but is provided within a similar reduced-oxygen environment or a comparison elastomeric article that comprises an antiozonant but is provided within a higher-oxygen environment.

### Claim 53 (depends on 52)

The packaged elastomeric article of claim 52, wherein the degradation is selected from holes in the elastomeric article, surface cracking, surface discoloration, and combinations thereof.

### Claim 54

A packaged elastomeric article to be sterilized using radiation sterilization, the packaged elastomeric article comprising:
an elastomeric article comprising an elastomer and one or more antidegradants; and
a package comprising a low-oxygen-permeable material,
wherein the elastomeric article is sealed within the package, and
wherein the package contains less than about 20 cm3 of trapped oxygen.

### Claim 55 (depends on 54)

The packaged elastomeric article of claim 54, wherein the elastomer comprises synthetic polyisoprene.

### Claim 56 (depends on 54)

The packaged elastomeric article of claim 54, wherein the one or more antidegradants comprises an antiozonant.

### Claim 57 (depends on 56)

The packaged elastomeric article of claim 56, wherein the antiozonant comprises an anionic wax emulsion.

### Claim 58 (depends on 54)

The packaged elastomeric article of claim 54, wherein the one or more antidegradants comprises an antioxidant.

### Claim 59 (depends on 58)

The packaged elastomeric article of claim 58, wherein the antioxidant comprises a butylated reaction product of p-cresol and dicyclopentadiene.

### Claim 60 (depends on 54)

The packaged elastomeric article of claim 54, wherein the package contains less than about 16 cm3 of trapped oxygen.

### Claim 61 (depends on 54)

The packaged elastomeric article of claim 54, wherein the package contains less than about 14 cm3 of trapped oxygen.

### Claim 62 (depends on 54)

The packaged elastomeric article of claim 54, wherein the package has a volume of about 335 cm3 or less.

### Claim 63 (depends on 54)

The packaged elastomeric article of claim 54, wherein the package has a volume of about 280 cm3 or less.

### Claim 64 (depends on 54)

The packaged elastomeric article of claim 54, wherein the package has a volume of about 225 cm3 or less.

### Claim 65 (depends on 54)

The packaged elastomeric article of claim 54, wherein the elastomeric article has a thickness of 0.22 mm or less.

### Claim 66 (depends on 54)

The packaged elastomeric article of claim 54, wherein the elastomeric article exhibits reduced degradation compared to a comparison packaged elastomeric article that does not comprise an antiozonant but is provided within a package containing less than about 20 cm3 of trapped oxygen or a comparison packaged elastomeric article that comprises an antiozonant but is provided within a package containing at least about 20 cm3 of trapped oxygen.

### Claim 67 (depends on 66)

The packaged elastomeric article of claim 66, wherein the degradation is selected from holes in the elastomeric article, surface cracking, surface discoloration, and combinations thereof.
