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Biological indicators (BIs) sterility testing

Sterilization´s routine monitoring and performance qualification. Sterility verification on biological indicators (BIs) for dry heat, steam, ETO processes as per ISO 11138 and USP [1229.5]. Population verification on BIs, inoculation of products and PCDs preparation are available upon customer´s request.

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Air Quality and Cleanrooms

The performance of a cleanroom is defined by a set of complex interactions between the airflow, sources of contamination and heat, position of vents, exhausts and any objects occupying the space. Consequently changes to any of these elements will potentially affect the operation of the cleanroom and could invalidate aspects of the room design.