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Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.
Pharmaceutical manufacturing environments are open to multiple sources of contamination from the air filtration systems to the process of materials transfer and the fact that a fully gowned operator can create more than 10,000 colony forming units an hour. As a result, measures need to be taken to ensure the safe and sterile transfer of APIs and formulation ingredients during aseptic processes. This article reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems (RABS), and split butterfly valve (SBV) technology.
eBook: Biologics and Sterile Drug Manufacturing
When referring to this article, please cite it as C. Dunne, “Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing,” Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2018).