The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Ensuring the integrity of container closure systems (CCS) is critical for the safety and efficacy of high-risk drug products. This whitepaper explores the regulatory landscape, key testing methods, and risk-based approaches required to qualify CCS for parenteral and ophthalmic applications....