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EFHSS Questions and Answers - Answer to Question Q00426

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EFHSS - Questions & Answers - Testing - Q00426
What is the purpose of integrators?
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From: (United Kingdom)   Date: 20 April 2004, 11:52 [GMT]
Subject: What is the purpose of integrators?

What is the purpose of integrators?

From: Josy Holdener (Switzerland)   Date: 22 April 2004, 11:37 [GMT]
Subject: Re: What is the purpose of integrators?

Dear Deborah

There are two categories of chemical indicators: process indicators and integrators. Process indicators just show that a product has been through a sterilization process and do not prove sterilization or sterilization conditions were achieved. Integrators show that sterilization conditions were met. It is important to understand the different types of indicators. Each has a different response to the detection of sterilizing conditions. Chemical indicators are divided into the following classes:

  • Class 1: Process indicators typically used on pouches and packages are indicating only that the item has been exposed to the sterilization process.
  • Class 2: Are specialty indicators utilized for special testing of sterilizer and performance such as the Bowie-Dick test, which assesses steam penetration and air removal.
  • Class 3: Are single parameter indicators that monitor only one factor of the sterilization process such as temperature or time.
  • Class 4: Are multi-parameter indicators that monitor more than one parameter such as time/temp, time/steam quality, and/or time temp/steam quality.
  • Class 5: Integrators have the same features as the multi-parameter indicators plus an incorporated time factor. In other words, integrators do not develop a reading upon first contact with the steriliant. Instead, they are designed to require exposure to the steriliant for a specific period of time before they change color. The ISO states that the performance of integrators is compared to the inactivation of the relevant test organism i.e. if the integrator is unsatisfactory; all items in that load should be reprocessed until all parameter demonstrate that sterility has been attained. Integrators can be used in steam and EO sterilizers, just as one would use a biological indicator.
  • Class 6. Emulators have the same feature of integrators. Its performance is based on a specified Sterilization cycle (primarily used in the Pharmaceutical-Industry). Emulators react not before approximately 95% of the Sterilization cycle is complete.

Please see also Question Q00331!

Best regards
Josy Holdener

From: (United Kingdom)   Date: 23 April 2004, 08:03 [GMT]
Subject: Re: What is the purpose of integrators?

Thanks for that Josy. The question is being asked in a unit entitled Identify and inspect equipment will it still be the integrators you mentioned or are there other types.
Thanks Debbie

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