What is Population Verification & Identification?

Biological indicators (BIs) have a manufacturer’s stated concentration of microorganisms contained within them. Population verification is a study that aims to confirm that the manufacturers stated value is representative of the batch. In addition, Biological indicators use an organism that is resistant to a sterilant used in your particular application, giving a worst case scenario sterilization approach. Geobacillus Stearothermophilus is commonly used as a biological indicator organism for steam sterilization as it is a thermophilic, heat resistant bacteria. Identification is a biochemical assessment of a BI to identify the species of bacteria contained within it.

Why do we do it?

The population or bacterial concentration of a BI is particularly important when measuring a log reduction required for calculating a desired Sterility assurance level (SAL). The purpose of Biological indicator identification is to perform biochemical assessment of the organisms within the biological indicator to ensure it correlates with the manufacturers stated species. All major pharmacopoeias recommend both population verification and identification be performed on each batch of biological indicators. This gives a degree of assurance in the manufacturers stated variables.

For further information and advice on Biological Indicators please browse our knowledge hub below, or contact us about your analytical testing requirements.

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