There are two goals to containing an HPAPI:
- Limit worker exposure at the source through engineering controls (containment) and diminish reliance on respiratory protective equipment (RPE) as a primary hazard control.
- Prevent airborne cross-contamination via properly designed high-potent rooms/suites.
- A potent pharmaceutical manufacturing facility consists of 3 components – 1) the HPAPI; 2) the workers; and 3) the environment that surrounds them. Containment is the isolation of the first component from the other two components. Containment, how it is achieved, how it is measured, and how it is maintained are key considerations for handling HPAPIs.
- The best solution is to manage containment at the source. There is no single universal solution for all situations involving HPAPIs. Challenges must be assessed within the context in which they occur and the applicable system constraints (time, schedule, cost, etc.). Sometimes an assessment at Metrics will conclude that a project should not be undertaken for various technical and cost reasons.
- Therefore, it is recommended to establish new product introductions as early as possible. This will better inform customers on containment strategy planning and negate last-minute and very expensive changes. CDMOs should have the flexibility to handle products at various potencies, scales and be able to alter or flex their processes according to client needs and specific HPAPI.