Annual and semi-annual cleanroom recertification under USP <797>, USP <800>, USP <825>, ISO 14644, FDA cGMP, BSL-2 / BSL-3, and Joint Commission requirements. Performed by CETA Registered Cleanroom Certification Professionals (RCCP) and NSF Accredited Technicians. A2LA ISO/IEC 17025 accredited laboratory.
A2LA Cert 2039.01 · ISO/IEC 17025 calibration · valid through April 2027 · A2LA Cert 7533.01 · Taylor Lake Laboratories biological testing · valid through September 2027 · Founded 1976 · 1,800+ accounts · Texas · Louisiana · Mississippi · Alabama · Florida · Los Angeles metro · nationwide field service
Commissioning qualifies a cleanroom. Certification keeps it qualified.
A cleanroom that passed commissioning two years ago is not the same cleanroom today. HEPA filters load with particulates and lose efficiency. HVAC dampers shift and the air balance drifts. Door gaskets wear and pressure differentials change. Personnel patterns and operational density shift over time. Recurring certification is how you stay qualified.
As cleanroom certification experts with over 50 years of experience, we know how important continuous compliance is to pharmaceutical compounding, hospital pharmacy, research, and industrial facilities under FDA, state board, Joint Commission, and accreditation body oversight. Our CETA Registered Cleanroom Certification Professionals and NSF Accredited Technicians bring precision to every recertification — delivering the comprehensive documentation regulators demand and the technical expertise your facility deserves.
"Recertification of installed filtration systems shall be performed at intervals not exceeding 12 months, except for ISO Class 5 systems which shall be tested at intervals not exceeding 6 months."
— ISO 14644-2:2015 (paraphrased)
Cleanroom certification services
Our comprehensive certification program addresses every component required for ongoing compliance under USP <797>, USP <800>, USP <825>, FDA cGMP, ISO 14644, BSL-2 / BSL-3, and Joint Commission Environment of Care requirements.
Environmental control equipment certification
- Biological safety cabinets (BSCs)
- Laminar airflow workbenches (LAFWs)
- Integrated vertical laminar flow zones
- Compounding aseptic isolators (CAI)
- Compounding aseptic containment isolators (CACI)
- Gloveboxes and isolators
- Sterile restricted pharmacy areas (SRPAs)
- Containment ventilated enclosures (CVEs)
Cleanroom recertification services
- Buffer room and anteroom certification
- Hazardous drug preparation and storage area certification (USP <800>)
- Airborne particle counting (non-viable)
- Air change rate verification (ACPH)
- Room pressurization monitoring
- Temperature and humidity validation
- HEPA filter integrity testing (DOP / PAO)
- Airflow visualization studies (smoke studies)
- ISO 14644-1 classification verification
Environmental monitoring (related service)
- Viable air sampling (CFU/m³)
- Surface sampling of critical areas
- Gloved fingertip sampling (GFTS)
- Sample plan development
- Incubation, analysis, and identification (under A2LA Cert 7533.01 by Taylor Lake Laboratories)
- Monthly sampling kit programs
Required certification frequency by classification
These are the regulatory floors. Your facility's quality manual, USP Category designation, FDA cGMP scope, or accreditation body may require more frequent recertification.
| Classification | Particle counts | Air change rates | Pressure mapping | HEPA integrity | Smoke studies |
|---|---|---|---|---|---|
| ISO Class 5 (PECs) | Every 6 months | Every 6 months | Every 6 months | Every 6 months | Annual |
| ISO Class 7 (buffer rooms) | Annual | Annual | Annual | Annual | Annual |
| ISO Class 8 (ante-rooms) | Annual | Annual | Annual | Annual | When applicable |
| BSC / LAFW / CAI / CACI | (covered under PEC cert) | (covered under PEC cert) | — | Annual under NSF/ANSI 49 | (covered under PEC cert) |
Allometrics builds the certification schedule to your specific requirements at contract setup, including post-event triggers — recertification after equipment relocation, repair, filter replacement, or any modification affecting the cleanroom's classification.
Industries we serve
Our cleanroom certification services protect patient safety, healthcare worker wellbeing, product quality, and research integrity across pharmaceutical, healthcare, research, and industrial settings.
Hospital sterile compounding
- Inpatient compounding pharmacies
- Hospital operating room pharmacies
- Surgical center pharmacies
- Hospital-based oncology pharmacies
- Hospital laboratories with compounding operations
Independent compounding pharmacies
- Sterile compounding pharmacies
- Small chain pharmacy networks
- 503B outsourcing facilities
- Hormone therapy compounding facilities
- Radiopharmaceutical pharmacies / nuclear medicine (USP <825>)
Specialized treatment facilities
- Oncology treatment centers and infusion clinics
- Physician-owned compounding operations
- Home infusion pharmacies
- Ambulatory surgical centers with compounding
- Veterinary compounding pharmacies
Research, biotech, and cGMP manufacturing
- BSL-2 and BSL-3 research laboratories
- Cell and gene therapy manufacturing facilities
- Academic research cleanrooms
- Contract research organizations (CROs)
- cGMP biopharmaceutical manufacturing
Industrial and manufacturing
- Cleanroom-dependent manufacturing
- Medical device cleanrooms
- Food processing facilities with cleanroom operations
- Cosmetics and nutraceutical cleanrooms
Whether you manage a single cleanroom or multiple controlled environments across multiple campuses, our nationwide service network provides consistent testing protocols and documentation formats across every site.
Why facilities trust Allometrics for cleanroom certification
CETA NSF certified expertise. We employ CETA Registered Cleanroom Certification Professionals and NSF Accredited Technicians for every certification engagement. Beyond credentials, this is the assurance that your testing follows the industry standards regulators expect to see during audits.
ISO 17025 accredited laboratory. A2LA accreditation under ISO/IEC 17025 means our certification documentation withstands FDA, state board, Joint Commission, and accreditation body scrutiny. Internationally recognized standards back every measurement we deliver.
50 years of experience. Since 1976, Allometrics has been the trusted partner for cleanroom certification. We've seen every regulatory change, guided facilities through countless transitions, and helped pharmacies, research labs, and industrial cleanrooms maintain compliance through five decades of industry evolution.
Drift visibility where the data is on file. Where a customer's commissioning data is on file with Allometrics — typically when commissioned by Precision Biotech Solutions — recertification reports include comparison to that baseline. Drift over time becomes visible in the same document set, supporting proactive HEPA replacement and HVAC remediation planning before a failure forces emergency response.
Nationwide consistency. Standardized protocols ensure every facility receives identical testing procedures and documentation formats — simplifying compliance management and reducing audit preparation time for multi-site operators.
Rapid response capabilities. Equipment failures and urgent certifications happen. Our nationwide network mobilizes quickly to minimize operational downtime and get you back to compounding, manufacturing, or research safely.
Multi-facility coordination for hospital systems and 503B operators
Hospital systems running cleanrooms across multiple campuses face a coordination problem most certification vendors cannot solve. A six-hospital system with two cleanrooms per campus has twelve cleanrooms with overlapping but not identical recertification schedules, six different facility managers, and (often) procurement requirements that make consolidating into one vendor difficult.
Allometrics manages multi-facility cleanroom certification programs as a single contract:
- Centralized scheduling — annual and semi-annual recertifications coordinated so no campus loses too much capacity at once.
- Consistent testing protocols and documentation formats across every site — the system's accreditation team gets a single deliverable to present to Joint Commission, FDA, or state surveyors.
- Single point of escalation for action-level findings — deficiencies route through a defined workflow rather than requiring the system's central quality team to translate between vendors.
- Same site visit as BSC and LAFW certification — when a campus has both PECs and surrounding cleanrooms certified by Allometrics, both are scheduled together for operational efficiency.
For multi-facility hospital systems and IDN-level RFPs, this consolidation is increasingly a procurement requirement, not a nice-to-have.
Why Allometrics — and the integrated Group cleanroom lifecycle
Allometrics is the recertification arm of the Allometrics Group's integrated cleanroom lifecycle. When Precision Biotech Solutions commissions a new cleanroom (initial qualification, IQ / OQ / PQ), Allometrics performs the recurring recertification using the commissioning baseline. When viable samples are collected during operations, Taylor Lake Laboratories incubates them under A2LA Cert 7533.01. When equipment in the cleanroom needs calibration, Allometrics performs that work under A2LA Cert 2039.01.
That continuity is the moat. A standalone certification vendor gives you a recertification report once a year and disappears between cycles. The Allometrics Group keeps the cleanroom's entire data record — commissioning, every recertification, every viables data point during the period — inside one organization with one quality manual and a continuous accreditation chain. When a deviation occurs three years in, the same field-service team can compare current performance to the original commissioning baseline because the same organization holds both data sets.
A2LA Cert 2039.01 · ISO/IEC 17025 calibration · valid through April 2027 · A2LA Cert 7533.01 · Taylor Lake Laboratories biological testing · valid through September 2027 · Founded 1976 · 1,800+ accounts · Texas · Louisiana · Mississippi · Alabama · Florida · Los Angeles metro · nationwide field service