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Case Study Overview: How to Gain Regulatory Approval for a Rapid Sterility Test


A Conversation with Sven Deutschmann of Roche Diagnostics and Ulrich Herber of Charles River Laboratories

Charles River and Roche Diagnostics recently collaborated to implement a rapid sterility test method into their manufacturing and quality control processes. Through close cooperation between the two company’s respective teams, Roche was able to release their product seven days earlier than the previously utilized compendial method.

“You know the technology best…” Sven Deutschmann, (Roche) Head of Adventitious Agents Testing and Alternative Microbiological Methods stated. “your lab is very well trained and educated… so, why shouldn’t we collaborate?”

Partnering with us to implement Celsis® rapid microbial methods opens the door to a whole platform for quality control optimization. Get a behind-the-scenes look into the implementation de-brief interview and see how Roche was able to reduce their validation time by 18 months. Vendors will also learn specific tips on how to incorporate a rapid system into their procedures.

Read Their Experience  Watch the Full Interview