THE WORLD LEADER IN CLEAN AIR SOLUTIONS CASE STUDY – PHARMACEUTICAL The Filtration Situation Air handling represented a unique challenge to the BioTechnique facility, since all of the products that BioTechnique produces must be manufactured in an aseptic environment. If a HEPA filter was somehow compromised and did not provide at least a 99.97% reduction in non-viable particulates, it could cause potential microbial growth in a product required to be sterile. Risk assessment analysis showed a potentially critical impact to patients if non-sterile products were used, which was unacceptable. A HEPA breach can be detected during the prescribed AQL sterility sampling of the product, during required environmental monitoring, or during the biannual HEPA certification process.

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