Establishing A Risk-Based Containment Strategy For High-Potency Micronisation

Containment has become a defining factor in pharmaceutical micronisation. As pipelines advance ever more potent compounds and product portfolios grow more complex, micronisation can no longer be treated as a particle-size reduction problem alone. It now demands containment strategies that manage the hazards of high-potency handling while protecting operators, preserving product quality and meeting regulatory expectations.

The difficulty is that no single approach fits every process. Containment must be evaluated across each handling and transfer step, with flexible containment and hard-wall isolator technologies serving complementary roles depending on the specific hazard, exposure potential, development stage and process requirements. Critically, the containment decisions made during development ripple downstream — shaping process scalability and the route to commercial manufacturing.

This session presents a risk-based framework for high-potency micronisation, illustrated through a practical case study that spans development to commercial scale. Attendees will see how to assess containment requirements across the full process; where flexible containment, hard-wall isolation or a combination of the two is most appropriate; and how thoughtful containment design and verification can reinforce operator safety, product quality and GMP compliance. The discussion will show how these principles inform process development, scale-up and manufacturing-partner selection — supporting safe, efficient and commercially relevant manufacturing.