EO biological test pack

• US 4,828,797 A
• Filed: 06/24/1986
• Issued: 05/09/1989
• Est. Priority Date: 06/24/1986
• Status: Expired due to Fees

• Current Assignee: Steris Corporation
• Original Assignee: Edward Weck Incorporated
• Inventors: Buglino, Steven T., Zwarun, Andrew A.
• Primary Examiner(s): Lacey, David L.
• Assistant Examiner(s): Johnson, Lori-Ann
• Application Number:
  US06/877,947
• Time in Patent Office: 1,050 Days
• Field of Search: 422/55, 422/56, 422/57, 422/58, 422/61, 422/86, 422/87, 422/88, 422/26, 422/102, 436/1, 206/438, 206/439, 206/363, 206/364, 206/365, 211/60.1
• US Class Current: 422/414
• 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: C12Q 1/22 Testing for sterility conditions

Abstract

A biological test pack adapted for use in testing the efficacy of an ethylene oxide sterilization process is described. The test pack is a clear plastic tray containing an sterilization sensitive ink which has been imprinted on a card which faces out of the bottom of the plastic tray. In addition, the tray contains a plastic syringe which holds a biological indicator. On top of the plastic syringe, absorbent paper is placed. The entire pack has a Tyvek sheet which seals it until it is used. The plastic tray is molded into a shape for holding the various items in particularly desirable locations. Accordingly, a disposable test pack which is uniformly manufactured and which should yield consistent results, is described. It can be used either as a general purpose routine test pack or as a validation challenge test pack.

Claims

1. A biological test pack for use in ethylene oxide sterilization processes comprising:

(a) a clear, colorless plastic tray including syringe holding means molded therein for holding a syringe containing a biological indicator;

(b) indicator card holding means for holding an indicator card adjacent to the bottom of said tray in a position so that the indicator card is raised away from possible condensate and is visible from outside of said tray;

(c) absorbent paper holding means for holding absorbent paper over said syringe;

(d) a biological indicator of the type including a glassine enclosed or a self-contained biological indicator;

(e) a syringe containing said biological indicator, said syringe being held in place within said tray by said syringe holding means;

(f) an indicator card having a sterilization sensitive ink imprinted thereon, said indicator card being held in said tray by said indicator card holding means with said ink imprint facing out of said tray; and

(g) absorbent paper held in place within said tray over said syringe by said absorbent paper holding means, whereby the combination creates a rate-limiting tortuous flow path; and

(h) means for sealing the top of said tray until it is ready for use.

2. The biological test pack of claim 1 wherein said syringe holding means is molded into said plastic tray.

3. The biological test pack of claim 2 wherein said indicator card holding means is molded into said plastic tray.

4. The biological test pack of claim 3 wherein said absorbent paper holding means is molded into said plastic tray.

5. The biological test pack of claim 4 wherein said biological indicator is a self-contained biological indicator or glassine enclosed spore strip.

6. The biological test pack of claim 5 wherein said absorbent paper is comprised of a stack of individual sheets of absorbent paper wherein said paper has an amount and rate of moisture absorption substantially equal to an all-cotton surgical towel of the type used in a standard AAMI test pack.