Simplified ethylene oxide sterilization test pack

• US 5,895,627 A
• Filed: 02/28/1997
• Issued: 04/20/1999
• Est. Priority Date: 02/28/1997
• Status: Expired due to Term

• Current Assignee: Minnesota Mining and Manufacturing Co (3M Company)
• Original Assignee: Minnesota Mining and Manufacturing Co (3M Company)
• Inventors: Khachatoorian, Armineh
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/808,598
• Time in Patent Office: 781 Days
• Field of Search: 422/27, 422/34, 422/61, 422/58, 422/86, 422/87, 422/292, 422/294, 436/1, 73/23.2
• US Class Current: 422/417
• CPC Class Codes: A61L 2/28 Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour apparatus involving enzymes or microorganisms C12M1/34; methods involving enzymes or microorganisms C12Q1/00
• CPC Class Codes: G01N 31/226 for investigating the degree of sterilisation

Abstract

A test pack for evaluating an ethylene oxide sterilization process, comprising an open ended fiber board tubular member, an end cap enclosing each end of said tubular member, said end caps defining a test chamber within the tubular member, one of said end caps having an opening to permit the egress of ethylene oxide into the test chamber. A fiber ball is inserted into the test chamber at a location remote from the end cap having the opening therein, and a chemical type sterilization indicator is placed within the test chamber.

Claims

1. A test pack for evaluating an ethylene oxide sterilization process, comprising:

(a) an open ended fiber board tubular member having first and second end;

(b) a first end cap enclosing the first end of said tubular member,

(c) a second end cap enclosing the second end of said tubular member,

said first and second end caps defining a test chamber within the tubular member, said first end cap having an opening to permit the entry of ethylene oxide into the test chamber;

said second end cap being closed to substantially restrict access of ethylene oxide into said test chamber through said second end cap;

(d) a fiber ball located in the test chamber; and

(e) a chemical type sterilization indicator located within the test chamber and spaced from said first end cap;

said fiber ball being located in said test chamber substantially adjacent said chemical indicator and said second end cap, said fiber ball being spaced from said first end cap, wherein the space between said first end cap and at least a portion of said chemical indicator is substantially free of any structures capable of substantially impeding the flow of ethylene oxide.

2. The test pack according to claim 1 wherein the fiber ball comprises rayon fiber or cotton fiber.

3. The test pack according to claim 1 wherein the fiber ball comprises rayon fiber.

4. The test pack according to claim 1 wherein the first and second end caps are made of metal or a polymeric material.

5. The test pack according to claim 1 wherein the chemical type ethylene oxide sterilization indicator utilizes a paper wick.

6. The test pack according to claim 1 enclosed within a pouch having at least one face which is permeable to ethylene oxide.

7. The test pack according to claim 6 wherein the ethylene oxide permeable face is paper.

8. The test pack according to claim 6 wherein the pouch comprises a first face impermeable to ethylene oxide consisting of ethylene glycol-terephthalic acid ester/polypropylene laminate, and an opposing paper trace, the pouch being sealed along three edges, and having a sealable forth edge through which the test pack can be inserted, and subsequently sealed.

9. The pouch according to claim 8 wherein the paper face has a message imprinted thereon which is readable through the ethylene oxide impermeable face.