Why HEPA filter integrity matters
When you depend on HEPA filter performance, you need testing and certification you can trust. Contaminated environments put your research, products, and people at risk. A single undetected leak can ruin pharmaceutical batches, contaminate experiments, expose workers to hazardous materials, or cause an FDA finding.
HEPA (High Efficiency Particulate Air) filter testing verifies that your filtration system is performing as designed — trapping the vast majority of microscopic particles that could contaminate your environment. Filter integrity testing (also known as Dispersed Oil Particulate or DOP/PAO testing) identifies leaks, tears, or gaps in the filter media, gaskets, or housing that could allow contaminants to bypass the filter.
The cost of a HEPA testing program isn't measured against itself — it's measured against the cost of a recall, a hold, a deficiency notice, or a containment failure. Allometrics has been performing HEPA certification and testing since 1976.
Why Allometrics for HEPA filter certification
CETA-certified technicians and NSF/ANSI 49 Field Certifiers. Our credentialed team works to IEST RP-CC0034.5 standards across pharmaceutical, healthcare, research, and industrial facilities.
Replace 3–5 vendors with one accredited partner. HEPA testing, BSC certification, cleanroom certification, fume hood certification, calibration, and viables — all delivered by the same team under one accreditation chain.
A2LA ISO/IEC 17025 accredited laboratory. While HEPA filter testing follows industry-specific protocols, our laboratory accreditation reflects the precision and reliability we bring to every service. NIST traceable standards across all our work.
50 years of regulated-environment experience. Founded 1976. The team has lived every USP revision, every FDA cGMP guidance update, every Joint Commission standards change.
Equipment we test
Allometrics performs HEPA and ULPA filter integrity testing on the full range of controlled-environment equipment:
- Biosafety Cabinets (BSCs) — Class I, II, and III cabinets for research and pharmaceutical applications
- Laminar Flow Workstations and Hoods — horizontal and vertical flow devices for sterile compounding and cleanroom operations
- Cleanroom Systems — buffer rooms, ante rooms, and ISO-classified controlled environments
- Isolators and Containment Systems — CAI, CACI, and pharmaceutical isolators for sterile and hazardous-drug compounding
- Animal Transfer and Change Stations — ventilated cage-change stations for research vivaria
- HEPA and ULPA Filter Banks — rooftop and in-line filtration systems for supply and exhaust air
- Powder containment hoods, specialized research equipment, custom installations — if your facility uses HEPA filtration for contamination control, air quality, or personnel protection, we can test it
Audit-ready certificates that pass FDA, USP, and Joint Commission review
Designed to pass FDA, USP, and Joint Commission audits on first review. Every Allometrics HEPA filter certification produces a signed certificate built to survive inspection. Each certificate includes:
- Equipment / room ID, serial number, manufacturer, model, customer asset tag
- Date of certification, technician (with credential), next-due date
- Standard the work was performed to (IEST RP-CC0034.5)
- Test results — DOP/PAO challenge concentration, downstream concentration, percent penetration, leak location and severity if any
- Pass/fail determination against the standard
- CETA / NSF certifier credential reference
Certificate format is designed for FDA inspections, USP <797>/<800>/<825> reviews by state pharmacy boards, Joint Commission MM/EC chapter reviews, ISO 9001 audits, and the operational-control requirements of every customer QMS we've worked under.
Industries we serve
Manufacturing & Industrial — pharmaceutical manufacturing, ISO classified cleanrooms, food processing, aerospace and aviation, petrochemical facilities, metallurgical operations.
Healthcare & Medical — hospital operating rooms / labs / pharmacies, inpatient and independent compounding pharmacies, radiopharmaceutical facilities, oncology clinics.
Education & Research — colleges and universities, independent research laboratories, BSL-2 and BSL-3 containment facilities (per CDC/NIH BMBL).
Government & Forensic — FDA facilities, FBI laboratories, crime and forensic laboratories, government research entities.
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Standards we work to
FAQ
Do HEPA filters require official certification? Yes. HEPA filters in critical environments require professional testing and certification to verify they're performing as designed. Filter integrity testing identifies leaks, tears, or gaps in the filter media, gaskets, or housing that could allow contaminants to bypass the filter. Allometrics provides comprehensive HEPA filter certification and testing services that include detailed reports documenting your system meets applicable standards — essential for regulatory compliance and audit readiness.
What standards must HEPA filter testing meet? HEPA filter testing must follow strict industry-specific protocols and federal and international safety guidelines. Allometrics follows standard operating procedures that comply with IEST RP-CC0034.5, NSF/ANSI 49 Annex F, ISO 14644-3, USP <797> / <800>, and manufacturer specifications. As an A2LA ISO/IEC 17025 accredited laboratory, we hold ourselves to high standards to ensure your testing results are accurate, defensible, and audit-ready.
What's the process for verifying HEPA filter integrity? HEPA filter integrity testing verifies that your filtration system is trapping the vast majority of microscopic particles that could contaminate your environment. Allometrics conducts filter integrity testing and leak detection that identifies problems in the filter media, gaskets, or housing. Our experienced technicians work with equipment from all major manufacturers — including biosafety cabinets, laminar flow hoods, cleanrooms, isolators, and HEPA filter banks. We provide detailed certification reports with all the data you need to demonstrate your controlled environment is performing as designed.
Do you test ULPA filters as well as HEPA filters? Yes. Allometrics provides comprehensive testing and certification for both HEPA (High Efficiency Particulate Air) and ULPA (Ultra-Low Particulate Air) filters. ULPA filters offer even higher efficiency than HEPA filters and are used in cleanrooms and controlled environments requiring the most stringent particulate control. Our testing methods and procedures apply to both filter types.