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EFHSS Questions and Answers - Question Q00099

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EFHSS - Questions & Answers - Testing - Q00099
Bowie-Dick Test Structure Program
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From: Alberto Franceschini (Italy)   Date: 14 September 2001, 11:06 [GMT]
Subject: Bowie-Dick Test Structure Program

Dear collegues,

the Bowie-Dick test structure program must be the same of the normal cicle program of steam sterilization?

Alberto Franceschini
Sterile production center
Ferrara
Italy

From: Josy Holdener (Switzerland)   Date: 17 September 2001, 10:13 [GMT]
Subject: Re: Bowie-Dick Test Structure Program

Hi Alberto,
The common Bowie-Dick test pack is placed horizontally on the bottom of the sterilizer rack, near the door, in an otherwise empty chamber.
A special prevacuum cyle ist run, with folowing parameters: exporure time of at least 3 minutes but not longer than 3-1/2 minutes, and a temperature setting of no more than 134°C, and no trying time.
Josy Holdener

From: (Belgium)   Date: 17 September 2001, 11:26 [GMT]
Subject: Re: Bowie-Dick Test Structure Program

Dear Alberto,
EN285: "Sterilization - Steam sterilizers - Large sterilizers" says in clause 7. Control systems:
7.1.14. Sterilizers which operate with a plateau period in excess of 3,5 min shall be provided with an automatic cycle for the Bowie and Dick test. This cycle shall have the same air removal stage as the sterilization cycle used for production, except that the plateau period shall be limited to the time specified in prEN 867-3 for the relevant temperature. This cycle shall be selected by means of a special key, tool or code.
Kind regards
Wim Renders

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