Our Certification Services

Cleanroom Certification

We perform comprehensive cleanroom certification testing in accordance with ISO 14644 standards. Services include airborne particle count testing, airflow velocity and volume measurements, HEPA filter integrity testing, room pressurization verification, and temperature/humidity monitoring.

Biological Safety Cabinet Certification

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We evaluate Class II biological safety cabinets using applicable NSF/ANSI 49 field certification procedures, manufacturer criteria, and the installed cabinet configuration. Testing includes inflow and downflow measurements, HEPA filter integrity, airflow smoke patterns, and applicable installation and exhaust checks. Additional tests are confirmed in the agreed scope. Results and any deficiencies are documented in your report.

Chemical Fume Hood Certification

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We evaluate chemical fume hood performance through face velocity measurements, airflow visualization, sash and physical condition review, and applicable airflow monitor checks. Reports document the test conditions, acceptance criteria, readings, and observed deficiencies. Routine face velocity and smoke testing are not equivalent to a complete ASHRAE 110 evaluation with tracer gas containment testing; contact us to confirm any additional testing requirements.

USP <797> / USP <800> Compliance

We provide full certification support for sterile and hazardous drug compounding environments. Our services help compounding pharmacies and hospitals maintain compliance with USP <797> and USP <800> requirements for cleanrooms, PECs, and SECs.

Glove Box Testing

We perform comprehensive glove box integrity and airflow testing to ensure your contained environments meet performance and safety requirements for handling hazardous or sensitive materials.

HEPA Filter Certification

Our HEPA filter integrity testing ensures your filters have no leaks, bypass, or performance degradation. We perform DOP/PAO aerosol challenge testing in accordance with industry standards to verify filter performance at all installation points.

Clean Bench Certification

We certify laminar airflow clean benches used in laboratory and compounding environments. Testing includes airflow velocity verification, HEPA filter integrity, and particle count testing to ensure your clean bench maintains the required ISO classification.

Air Changes Per Hour (ACH) Verification

We measure and document air changes per hour in cleanrooms, buffer rooms, and ante-rooms to verify compliance with USP <797>, USP <800>, and ISO 14644 requirements. Proper ACH rates are critical for maintaining ISO classification and regulatory compliance.

Microbial Sampling

Our environmental microbial sampling services support USP <797> and USP <800> compliance programs. We perform viable air sampling and surface sampling to monitor microbial contamination levels in your compounding and laboratory environments.

Differential Pressure Verification

We verify and document room-to-room pressure differentials in cleanrooms, buffer rooms, and ante-rooms to ensure your facility maintains the required positive or negative pressure relationships for USP <797> and USP <800> compliance.

CGMP Facility Certification

We provide certification services for Current Good Manufacturing Practice (cGMP) facilities including pharmaceutical manufacturing plants, biotech production facilities, and contract manufacturing organizations. Our testing ensures your facility meets FDA cGMP environmental requirements.

BSL-3 Facility Certification

We support Biosafety Level 3 facility certification requirements including directional airflow verification, negative pressure confirmation, HEPA exhaust filter integrity, and ventilation system performance testing to meet CDC/NIH biosafety guidelines.

Research Facility Certification

We provide comprehensive certification services for university research labs, government research facilities, and private research institutions. Our team handles all aspects of cleanroom and controlled environment certification to keep your research operations compliant and uninterrupted.