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News
3 Mar 2011

Celerion Adds New Clean Room for Drug Solutions

The addition of the USP 797 Clean Room allows for complex extemporaneous compounding for low, medium and high-risk investigational compounds.

Celerion announced its completion of a new 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.

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

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