Biological indicators for sterilisation in an isolator

M. Meyer Internal validation manager,
Getinge Life Sciences,
Vendôme, France

Biological Indicators (in general 106 spores inoculated on a physical medium) are used, beyond the validation of core terminal sterilisation processes, for the development and verification of bio-decontamination cycles for isolators that include the atmosphere and surfaces.

This type of bio-decontamination is mainly performed using vapours of peracetic acid or hydrogen peroxide (H2O2) as discussed in the present contribution.

This use raises problems as to the choice of the strain of bacteria, its medium and the reliability / reproducibility of its fabrication.

Having reviewed the various techniques for implementation of H2O2 vapours, this presentation is intended to examine the “why”, “where” and “how” issues involved in using biological indicators on isolator validation/qualification and highlights the problems that need to be avoided.

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