Cleanroom Certification | USP 795 & 797 Revisions

by | May 23, 2023

A cleanroom certification shall be performed prior to initiating sterile operations and must be repeated at least every six months and/or after any changes to the classified area including construction, replacement, or relocation of any primary engineering control (PEC), and any reconfiguration of the room and major equipment.

Classified areas and engineering controls are certified by performing airflow testing, HEPA filter integrity testing, total particle count testing, differential pressure testing, dynamic airflow smoke patterns test, and by having viable environmental monitoring. 

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