Strategies for Managing the Leachables Risk for Container Closure Systems

This presentation will focus on key strategies to ensure compliance with the new series of USP chapters that cover extractables and leachables for container closure systems: USP 661.2, 1663, 1664 and how they correlate to following additional topics:

• A review of the PQRI “Best Practices” for performing E&L Testing

• New PQRI recommendations for setting thresholds and calculating the Analytical Evaluation Threshold (AET)

• FDA Expectations for “high risk” and “low risk” dosage forms

• Using the FDA food contact regulations for container closure system materials of construction to reduce or even eliminate E&L testing for oral and topical drug products

• Preparing an E&L materials assessment report to detail the strategies used in designing and performing the E&L testing

Dr. Michael Ruberto is a retained consultant to Pine Lake Laboratories available to support all extractable and leachable studies, as well as the President of Material Needs Consulting, LLC which provides consulting services to manage the development and commercialization of medical devices and packaging. Dr. Ruberto is an active member of various pharmaceutical groups that have developed “best practices” for characterizing and evaluating the safety of container closure systems.

Light refreshments will be served prior to Dr. Ruberto’s presentation.