Precision in Controlled Climates.
Ensure your cleanroom meets regulatory standards with certified, audit-ready testing. TruMetric's Cleanroom Certification Services help pharmaceutical, biotech, medical device, semiconductor, and healthcare facilities maintain compliance with ISO, USP, FDA, and EU GMP requirements.
Why TruMetric?
Validated Environments You Can Trust
Not all cleanroom certification partners are created equal. TruMetric combines technical expertise, advanced technology, and industry experience to deliver proven reliability in controlled environments. We provide comprehensive cleanroom testing, validation, and documentation so your facility remains compliant, efficient, and inspection-ready. From initial certification through ongoing environmental compliance testing, we ensure every step of the process meets the highest certification standards, like ISO 14644 and FDA 21 CFR.
Technical Expertise
TruMetric delivers ISO 14644 cleanroom testing, controlled environment certification, and HEPA & ULPA filter integrity testing. Our experienced technicians are trained in ISO, USP, and GMP cleanroom standards.
Comprehensive Filter Integrity and Airflow Testing
We perform filter installation verification, PAO/DOP filter leak testing, leak detection and remediation guidance. TruMetric's advanced airflow visualization and containment testing—featuring smoke studies, airflow pattern analysis, containment verification, and Annex 1 airflow studies—ensures cleanroom performance and regulatory compliance.
Controlled Environment Certification
TruMetric provides controlled environment certification services including laminar flow hood certification, NSF/ANSI 49 biological safety cabinet (BSC) testing, compounding pharmacy cleanroom certification, isolator and glovebox testing, and pass-through chamber validation.
Regulatory Compliance
Cleanroom certification verifies that your controlled environment meets the required cleanliness classifications, airflow performance standards, and environmental control specifications, including compliance with ISO 14644, USP <797> and USP <800>, FDA 21 CFR, and NSF/ANSI 49.
Cleanroom Certification Services
Environmental Testing, Certification, and Compliance Support
TruMetric provides end-to-end cleanroom certification and validation services that ensure controlled environments meet the highest standards of accuracy and regulatory compliance. From initial certification to ongoing compliance testing, our team delivers precision, comprehensive documentation, and data you can trust.
Comprehensive Testing
- TruMetric offers cleanroom testing and certification, including pre-certification consultation, on-site performance testing, and compliance verification
- We offer a comprehensive certification package with documented test results and remediation recommendations.
- This includes temperature and humidity validation, differential pressure testing, Annex 1 airflow studies, and filter integrity testing using NIST-traceable equipment, all culminating in a full audit-ready report.
Controlled Environment Certification
- Routine certification protects product integrity, patient safety, and regulatory compliance
- We focus on critical environmental equipment, including laminar flow hoods, biological safety cabinets, and pass-through chambers
- All tests are conducted with the highest standards, using NIST-traceable equipment that is calibrated and maintained to ensure accurate, defensible results
Documentation & Reporting
- Detailed, audit-ready documentation formatted for FDA, state board, and GMP inspections
- Reports include data analysis and compliance verification
- Digital record delivery offers full traceability and secure storage for easy access, helping you adhere to all internal certification standards.