# US 2024/0189463 A1 · Sterilization method for medical rubber part

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- Number: US 2024/0189463 A1
- Document ID: US20240189463A1
- Status: Published application
- Kind: A1
- Application number: 18/382,182
- Filed: 2023-10-20
- Published: 2024-06-13
- Earliest claimed: 2022-10-21
- Assignees: Sumitomo Rubber Industries, Ltd.
- Applicants: Sumitomo Rubber Industries, Ltd.
- Inventors: Yogun KIDA; Kei TAJIMA; Kazuki NOJIRI; Yuichiro MATSUTANI; Shumpei MORITA
- Web page: https://patentgrep.com/patent/US20240189463A1

## CPC

- A61L 2/081: Gamma radiation
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2103/23: {Containers other than laboratory or medical, e.g. bottles or mail}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

A sterilization method for a medical rubber part is a sterilization method for a medical rubber part that can include a body made from an elastic material and that can include an inactive resin film stacked on at least a portion of a surface of the body, where the sterilization method can include irradiating a packaging article with gamma ray, the packaging article accommodating a plurality of the medical rubber parts and having an oxygen concentration not higher than 5%.

## Claims

### Claim 1

A sterilization method for a medical rubber part that includes a body made from an elastic material and that includes an inactive resin film stacked on at least a portion of a surface of the body, the sterilization method comprising:
irradiating a packaging article with gamma ray, the packaging article accommodating a plurality of the medical rubber parts and having an oxygen concentration not higher than 5%.

### Claim 2 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, further comprising irradiating a packaging article with the gamma ray, the packaging article having an oxygen concentration not higher than 3%.

### Claim 3 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, wherein the packaging article having an oxygen concentration not higher than 5% is a packaging article in which nitrogen is sealed.

### Claim 4 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, wherein the packaging article having an oxygen concentration not higher than 5% is a packaging article in which an oxygen adsorber is sealed.

### Claim 5 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, further comprising performing irradiation with the gamma ray such that an absorbed dose of the gamma ray is not lower than 15 kGy.

### Claim 6 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, wherein the elastic material is composed of a rubber or a thermoplastic elastomer, has a JIS-A hardness not lower than 30 and not higher than 70, and has a compression set not higher than 20%.

### Claim 7 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, wherein the inactive resin is polytetrafluoroethylene (PTFE), tetrafluoroethylene-ethylene copolymer, or ultrahigh-molecular-weight polyethylene.

### Claim 8 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, wherein the inactive resin film has a thickness of 10 μm to 150 μm.

### Claim 9 (depends on 1)

The sterilization method for the medical rubber part, according to claim 1, wherein the medical rubber part is a rubber plug for a vial, a cap or a plunger stopper for a syringe, or a rubber plug for a vacuum blood collection tube.