Cleanroom Certification | USP 795 & 797 Revisions
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.
Thank you for reading this post, don't forget to subscribe!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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Eagle is a U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) registered A2LA ISO 17025 accredited laboratory founded in 2003 that provides analytical chemistry and microbiological testing, consultation services, and other technical services for pharmacies, highly regulated industries, and research organizations to support their compliance needs.
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