A case study for seal quality and container closure integrity testing across the life cycle of sterile products

A case study for seal quality and container closure integrity testing across the life cycle of sterile products
•USP is a major update and a gap assessment is recommended between it and the current way of working
•A case study was presented for the following:
Building a strategy for closing gaps and mitigating risks
Rationalizing CCIT and seal quality methods as part of the quality assurance with a scientific- and risk-based approach
Applying various test methods across the product life cycle for specific CCS formats