Method of sterilizing medical articles

• US 5,014,494 A
• Filed: 09/27/1988
• Issued: 05/14/1991
• Est. Priority Date: 09/27/1988
• Status: Expired due to Fees

• Current Assignee: Sherwood Services AG
• Original Assignee: Sherwood Medical Company (Medtronic Plc)
• Inventors: George, Robert D.
• Primary Examiner(s): Spruill, Robert L.
• Assistant Examiner(s): Johnson, Linda B.
• Application Number:
  US07/249,979
• Time in Patent Office: 959 Days
• Field of Search: 53/425, 53/432, 53/433, 53/434, 53/449, 422/22, 422/23, 422/24
• US Class Current: 53/425
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: B65B 55/16 by irradiation

Abstract

In a method of radiation sterilization of medical articles, replacing the oxygen in the sterilization package with nitrogen prior to sterilizing prevents most of the brittleness and discoloration in the articles.

Claims

1. A method of sterilizing medical articles which comprises:

(a) placing the articles in gas permeable packages,

(b) sealing the packages,

(c) placing the packages in sealable containers,

(d) sealing the containers,

(e) pumping a non-reactive gas into the sealed containers,

(f) permitting the packages to remain in the containers until the oxygen in the packages has been purged therefrom by the non-reactive gas, and

(g) irradiating the packages and the articles to sterilize the latter while the packages are essentially purged of oxygen.

2. The method of claim 1 wherein the atmosphere of non-reactive gas is nitrogen.

3. The method of claim 1 wherein the articles are plastic syringes.

4. The method of claim 1 wherein the packages are irradiated in said containers.

5. The method of claim 1 wherein the packages are permitted to remain in said containers as described in step (f) for a period of time from under a minute to several hours to allow oxygen in the packages to be purged thereform.

6. A method of sterilizing a medical article which comprises:

(a) placing at least one article in a gas permeable package,

(b) sealing the package,

(c) placing at least one package in a sealable container,

(d) sealing the container,

(e) pumping a non-reactive gas into the sealed container,

(f) permitting the at least one package to remain in the container until the oxygen in the package has been purged therefrom by the non-reactive gas, and

(g) irradiating the at least one package and the at least one article to sterilize the latter while said package is essentially purged of oxygen.

7. The method of claim 6 wherein the atmosphere of non-reactive gas is nitrogen.

8. The method of claim 6 wherein the at least one article is a plastic syringe.

9. The method of claim 6 wherein the at least one package is irradiated in the container.

10. The method of claim 6 wherein the package is permitted to remain in the container as described in step (f) for a period of time from under a minute to several hours to allow oxygen in the package to be purged therefrom.