Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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40 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Tech Transfer T he manufacture of sterile drug forms must be subjected to strict controls to minimize the risk of contamination by micro-organisms, endotoxins, and particles. Because the presence of something unwanted in a dosage form can pose serious risks, legislation demands that steps be taken to reduce these risks that threaten product quality and ultimately pa- tient safety. Pharmaceutical manufacturing environments are open to multiple sources of contamination from the air filtration systems to the pro- cess 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 trans- fer 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. Sterile containment techniques Sealed transfers and barrier technologies have been designed to con- tain aseptic manufacturing processes. They provide a robust alterna- tive to conventional "cleanroom only" methods of handling sterile products, ensuring that pharmaceuticals are not exposed to viable organisms or particulate contamination, while also protecting opera- tors from potent compounds. Aseptic Transfer Technology: Weighing Up the Advantages of Varying Approaches for Sterile Drug Manufacturing Christian Dunne The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology. Christian Dunne is global product manager for ChargePoint AseptiSafe. CERGIOS/SHUTTERSTOCK.COM

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