Surface Sampling for ISO Class 5 Primary Engineering Controls

In the compounding of pharmaceuticals, Primary Engineering Controls (PECs) are critical in ensuring final product integrity and public safety. Equipment such as compounding aseptic isolators (CAIs) and biological safety cabinets (BSCs) must be contamination free, and this requires diligent monitoring to maintain standards to PEC ISO 5 classification. According to USP <797> guidelines, flat interior surfaces of PECs should be sampled for microorganism contamination per your organization’s Standard Operating Procedures (SOPs) and as part of any Environmental Sampling Plan (ESP) and, to this end, contact plates are a primary tool for performing surface sampling. However, given their gelatinous nature, these devices also leave behind a residue that must be diligently removed through careful cleaning performed using prescribed tools and techniques. For a primer on both surface sampling and the most effective cleaning of your PECs, read on…

 

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