Multiple Fill Line Delivery Experience

Drawing on case studies from multiple pharmaceutical facilities, this document outlines how a strategic approach to commissioning and qualification (C&Q) can facilitate the successful startup of complex filling lines. It details a global strategy for insulin cartridge filling that was implemented across two new greenfield facilities, showcasing how comprehensive design reviews, detailed planning, and reusable test cases streamlined the process and minimized schedule impacts. It also highlights a project involving a sterile injectable tech transfer, where a scale-down and characterization strategy accelerated regulatory submissions and enabled seamless regulatory approval with zero deviations.

By taking a proactive approach to engineering changes and validation efforts, companies can achieve operational readiness more rapidly and efficiently. To explore these methodologies in detail, access the full case study.