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EU24CEMAR1/SES202 - CCS Implementation for Sterilized Production Equipment

‐ Mar 12, 2024 11:45am

With the recent implementation of the new version of European Union EudraLex Volume 4 Annex 1 (or simply Annex 1), pharmaceutical manufacturers must evaluate maintenance of product contact equipment through cleaning and sterilization as part of the Contamination Control Strategy (CCS). According to Annex 1, the CCS includes a set of controls for microorganisms, endotoxin/pyrogens, and particles to ensure process performance and product quality. It is especially critical to define the contamination risks and identify appropriate controls for critical surfaces, namely product contact equipment that is cleaned, sterilized, and used in parenteral drug manufacture.

This presentation walks through an example “life cycle” for product contact equipment, identifying potential contamination risks and mitigation solutions, to demonstrate best practices for achieving CCS implementation and regulatory compliance. 

Details on protection of clean product contact parts and sterilization in the autoclave are included. Post sterilization maintenance, including material transfer and aseptic presentation into the filling environment (isolator or RABS), rounds out the life cycle evaluation.