Pharmaceutical Technology - May 2020

Pharmaceutical Technology – Biologics and Sterile Drug Manufacturing

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38 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m Operations P harmaceutical Technology spoke with Richard Denk, senior consultant aseptic processing and containment, SKAN AG, about the risks of contamination in biopharmaceutical manufacturing and how this risk can be mitigated. Contamination issues PharmTech: What types of contamination can occur in biopharma- ceutical manufacturing? Denk (SKAN): In biopharmaceutical manufacturing, [there] are many risks of contamination such as microbiological contamination; par- ticle contamination from fibers, skin, surfaces, etc.; contamination from cleaning agents; and/or contamination from different products produced before in the room. As I'm focused in aseptic processing, the contamination control strategy (CCS) for Grade A /ISO 5 and sourrounding is our major focus. In this area, we are focusing on the critical aseptic zone and the transfers of material, tools, etc., in the critical aseptic zone. PharmTech: Where in the manufacturing process is product most vulnerable to contamination? Denk (SKAN): Open process and direct access to critical open opera- tions are the highest risk of contamination. This means, especially for aseptic processing, the filling of the container (e.g., vials, sy- ringes, etc.) and the following steps like stoppering and lyophiliza- tion (if part of the process) until the container is sealed [are crucial]. Beside the open sterile product, each transfer from a lower clean- room grade into the Grade A area is critical for contamination. For GORODENKOFF - STOCK.ADOBE.COM Considerations in Contamination Control Susan Haigney A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

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