Method for sterilizing

• US 5,496,302 A
• Filed: 04/29/1992
• Issued: 03/05/1996
• Est. Priority Date: 03/10/1989
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Woodworth, Archie, Minshall, Billy W., Sintim-Damoa, Kwame, Purohit, Kailash, Nygard, John E., Giesler, Richard
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): HANLON, BRIAN EMMETT
• Application Number:
  US07/876,125
• Time in Patent Office: 1,406 Days
• Field of Search: 604/410, 604/408
• US Class Current: 604/410
• CPC Class Codes: A61L 2/0023 Heat
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/20 Gaseous substances, e.g. vapours
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components

Abstract

Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.

Claims

1. A method for sterilizing a first part of a product portion, said first part having means defining a flow path, said flow path having a proximal end communicating with the remainder of said product portion and a terminal end distal from said proximal end, said method comprising the steps of:

blocking said flow path to the ingress of microorganisms at a location spaced from said terminal end so as to form an isolated terminal end portion;

exposing at least a portion of the interior of said isolated terminal end portion to an non-sterile environment;

exposing at least said isolated terminal end portion to an electron beam while shielding at least a part of the remainder of said product portion from the electron beam; and

unblocking said isolated terminal end portion to provide an open flow path between the remainder of said product portion and said terminal end of said flow path.

2. The method of claim 1 said method including the step of exposing said product portion to a selected form of sterilization that does not include electron beam radiation.

3. The method of claim 2 wherein said flow path is blocked after said product portion is sterilized by said selected form of sterilization and before said at least a portion of said interior of said isolated terminal end portion is exposed to a non-sterile environment.

4. The method of claim 1 wherein said product portion includes a plastic container with contents therein and said means defining the flow path comprises a plastic tube and means providing a sterile protector over said terminal end, said method including:

exposing said product portion to a form of sterilization that does not include electron beam radiation;

removing said sterile protector, thereby exposing said at least a portion of said interior of said isolated terminal end portion to a non-sterile environment before the step of exposing at least said isolated terminal end portion to an electron beam.

5. The method of claim 1 wherein said flow path is blocked by providing a frangible closure device disposed within said flow path.

6. A method for sterilizing a first part of a product portion, said first part having means defining a flow path, said flow path having a proximal end communicating with the remainder of said product portion and a terminal end distal from said proximal end, said method comprising the steps of:

isolating the terminal end from the remainder of said product portion by applying a clamp to said flow path at a location spaced from said terminal end so as to form an isolated terminal end portion;

exposing said isolated terminal end portion to a non-sterile environment;

exposing at least said isolated terminal end portion to an electron beam while shielding at least a part of the remainder of said product portion from the electron beam;

opening said isolated terminal end portion to provide an open flow path between the remainder of said product portion and said terminal end of said product portion.