By Carol A. Houts, Chief Strategy Officer, Germfree Laboratories
Containment isolators are essential components in high containment environments, such as biosafety level 3 (BSL-3) laboratories, and for handling hazardous drugs with low occupational exposure limits. Achieving dual compliance with both cGMP and BSL-3 presents a particular challenge for containment isolators. Here, we review process requirements, workflows, and process interventions that are key inputs into the development of user requirement specifications. This includes requirements for critical design elements, passthrough technology, work surfaces and cleanability and more.