Case Study Moving from a RABS to an Isolator

A case study of a CDMO, MilliporeSigma, moving from an aging RABS filling line to a SKAN/Bausch & Strobel Varyosis isolator line per Annex 1. This presentation will review challenges and successes with installing, validating and implementing a new isolator filling line including strategic regulatory filing strategies to assess moving commerical and clinical clients from the RABS to the isolator. A panel presentation with the manufacturing site, sterility assurance consultant supporting line aseptic readiness, Jeff Yuen (former FDA) regulatory strategy, and Merritt Postma SKAN isolator vendor. Improved contamination control strategy results of validation and readiness of the isolator line will be reviewed.