View, browse and sort the list of CPhI North America Conference sessions and show floor programming by pass type, track, and format. Seating is first come, first serve, so please arrive early to sessions that you would like to attend. Sessions are subject to change.

Containment Performance Testing (CPT) and Development of Permitted Daily Exposure (PDE) Values for Product Quality and Cross-Contamination Protection


Charlyn Reihman (Principal Occupational Health Consultan, Safebridge Consultants, Inc)

Allan Adler (Managing Director, Safebridge Consultants, Inc)

Location: Insight Briefing Theater

Date: Tuesday, April 24

Time: 11:30am - 12:15pm

Pass Type: Conference Pass, Exhibitor, Expo Only, VIP Attendee - Get your pass now!

Track: Insight Briefing

Vault Recording: TBD

Safebridge Consultants, Inc.

In the manufacture of potent active pharmaceuticals ingredients (APIs), process containment is required for both worker protection and product protection to prevent overexposure and cross-contamination, respectively. To verify the adequacy of controls, containment performance testing (CPT) is needed both at the vendor (factory acceptance testing) and site (site acceptance testing). Because of the nature of particulates, a dynamic test using surrogates or the API themselves is required to mimic the conditions of manufacture or R&D operations. In parallel, as the drug reaches Phase II or further, to adequately assess the potential for cross-contamination, a Permitted Daily Exposure (PDE) value is needed for the API and sometimes key intermediates in the process. The PDE is for patient safety purposes and is used to establish a Maximum Allowable Carry Over (MACO) from product to product needs to be developed to meet the European Medicines Agency (EMA) or other regulatory cross-contamination guidelines. The importance of process containment to product quality and worker protection, how to conduct CPT testing, and how to derive scientifically robust PDEs will be provided.