Often companies face excessive environmental monitoring excursions in cleanrooms as well as media fill and product failures despite the facility being qualified. Gaps in qualification can lead to severe consequences, delays in production and even regulatory scrutiny.
A successful qualification depends upon multiple milestones; each addressed with a thorough knowledge base and process control. Understanding the relevance of each step during design and qualification of cleanrooms provides confidence in the contamination control effect of the cleanrooms and barrier systems.
Emily Cheah (Moderator)
Managing Director of Charles River Laboratories (Singapore)