Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products. In sterile manufacturing and aseptic fill/finish of pharmaceutical products, isolator technology offers the ability to achieve high sterility levels. Pharmaceutical Technology spoke with two experts to learn about best practices in specifying and operating isolators. Richard Denk is senior consultant for Aseptic Processing & Containment at SKAN AG, which designs and manufactures isolators, isolator process solutions, and cleanroom equipment. Denk founded the Parenteral Drug Association (PDA) Isolator Expert Group, which has published guidelines for isolator design and cleaning. Denk was also responsible for writing about transfer systems and isolator design for PDA’s technical report on isolators, which will be published in 2020, and is chair of the International Society for Pharmaceutical Engineering Germany/Austria/Switzerland (ISPE D/A/CH) Affiliate’s Containment Expert Group, which published the ISPE Containment Manual. Steve Nole is vice-president of operations at Grand River Aseptic Manufacturing (GRAM), a contract development and manufacturing organization (CDMO) for parenteral pharmaceuticals. GRAM is building a new aseptic processing facility, near its existing facility in Grand Rapids, Michigan, that uses isolator technology from SKAN. The company is currently in the process of equipment qualification, with good manufacturing practice (GMP) production planned for start-up in September 2020.

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• Isolator

• Isolation Technology

• Pharmaceutical Technology

• 2/1/2020

• Article