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Celerion Adds USP 797-Compliant Clean Room

Celerion has completed a clean room and pharmacist certification to comply with USP 797 guidelines.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Celerion has completed a clean room and pharmacist certification to comply with USP 797 guidelines. The certification allows in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The USP 797 clean room allows for complex extemporaneous compounding for low, medium and high-risk investigational compounds. This solution, combined with the company’s early stage adaptive trial designed studies, is designed to help clients reach clinical proof-of-concept faster.

The clean room design includes an ante-room that serves two individual clean rooms, one clean room is a dedicated microtracer area, which contains a Class A2 Biological Safety Cabinet for radiolabeled microtracer compounding, and an additional clean room contains a laminar flow hood for traditional IV compounding. Both clean rooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.

“The addition of the USP 797 Clean Room continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier,” said Phil Bach, vice president of Clinical Research at Celerion. “The clean room when combined with our Lincoln, Nebraska, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.”

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