Clean Room & Pharmacy Certification

Cleanroom certification services in Florida & Puerto Rico

Cleanroom certification for compounding pharmacies, IVF and research labs: ISO 14644 classification, USP <797> and <800> certification every six months, and the viable air and surface sampling that goes with it. One schedule, one report set, managed by BMCA.

Get a cleanroom certification quote Call 305.238.5326

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Cleanroom certification near you

We schedule cleanroom and compounding pharmacy certification across Florida and Puerto Rico, and plan your semiannual dates in advance so a certification never lapses. Call 305.238.5326 to set your next window. New to the requirements? Read cleanroom certification: what is tested and how often.

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.

Built for the facilities we serve

Hospital & outpatient pharmacies

Semiannual USP certification for state board and Joint Commission.

Compounding & infusion

503A, 503B, home infusion and oncology suites.

IVF & cell-culture labs

Room classification and laminar-flow verification.

Research & university labs

BSL facility verification for IBCs.

Molecular labs

Pre-PCR clean room classification.

Medical-center groups

Multiple sites on one recurring program.

Clean room & compounding pharmacy certification — common questions

How often does a compounding pharmacy need certification?

USP <797> requires certification of primary and secondary engineering controls at least every six months, and after any change to the space, HVAC or equipment. Viable sampling has its own cadence; we run both as one recurring program.

Who performs the work?

BMCA manages, schedules and documents. Certification and sampling are performed by Medrep Technologies, our preferred subcontracted certification partner — certifying clean rooms, containment facilities and cabinets in Florida since 1984.

What do we receive?

A certification report per room and per engineering control — particle counts, pressures, air changes, HEPA integrity, viable results against action levels, next-due date — filed to your equipment records and produced on demand for any surveyor.

Can you also handle our biosafety cabinets and fume hoods?

Yes — see biosafety cabinet certification. Everything is scheduled as one visit where possible.

Do you decontaminate rooms and cabinets?

Yes, by paraformaldehyde, vaporized hydrogen peroxide or chlorine dioxide. See decontamination & removal.

What does cleanroom certification include?

Airflow and air-change measurements, HEPA filter leak testing, non-viable particle counts against the ISO class, room pressure differentials, airflow smoke studies in the primary engineering controls, and viable air and surface sampling. Read the full guide.

Get your cleanroom certification quote.

Tell us the equipment, make and model, and where it is. We'll reply within one business day with a quote and the earliest service date. No obligation.

Prefer to talk? Call 305.238.5326