Clean room & compounding pharmacy certification

Certification proves the room works. Sampling proves the practice does.

Compounding pharmacies, IVF labs and containment facilities carry a certification burden most equipment vendors can't touch. BMCA manages it as part of your compliance program — engineering controls, room classification and personnel sampling scheduled together so nothing lapses between visits.

What's certified

• Clean rooms and anterooms — ISO 14644 particle counts and classification, pressure differentials, air changes per hour, HEPA integrity
• USP <797> sterile compounding — semiannual certification of primary and secondary engineering controls
• USP <800> hazardous drugs — containment PECs, negative-pressure rooms, externally vented enclosures
• Laminar airflow workbenches, CAIs, CACIs and Class II cabinets inside the suite
• Biocontainment facilities BSL-1 through BSL-3, including animal facilities
• FS 209E classification where a quality system still references it

Viable sampling and personnel testing

• Active volumetric air sampling at ISO 5 / 7 / 8 locations
• Surface sampling by contact plate and swab
• Media-fill testing for compounding personnel
• Gloved fingertip and thumb sampling
• Non-viable particle counts recorded with each certification

Clean room, compounding pharmacy and containment certification services are managed by BMCA Group Inc. and performed by Medrep Technologies, Inc. (Port Charlotte, FL), our preferred subcontracted certification partner. BMCA remains your single point of contact for scheduling, documentation and follow-up.

Clean room & compounding pharmacy certification — common questions