Certification
Formal certification is the technical validation of your facility's integrity and its ability to protect critical processes.
A cleanroom must be periodically tested to ensure it continues to operate within its designated ISO or GMP parameters. CleanTech Facility Services provides independent, third-party certification and testing according to ISO 14644-1:2015 standards. Our certified technicians use calibrated instrumentation to verify particle classifications, airflow patterns, and environmental stability, providing the formal documentation needed for regulatory compliance and quality assurance.
We don't just provide a PASS/FAIL; we provide the diagnostic data needed to understand your facility's performance trends.
Particle Counting
Verification of ISO 14644-1 cleanliness levels.
Airflow Testing
HEPA face velocity and ACH verification.
Filter Integrity
DOP/PAO leak testing of HEPA/ULPA systems.
Validated Performance
Our certification protocols include a comprehensive suite of tests to validate every dimension of cleanroom performance:
- Airborne Particle Count Testing (As-built, At-rest, Operational)
- Airflow Visualization (Smoke Studies)
- Differential Pressure Verification (Room-to-Room)
- Light Level, Sound Level, and Vibration Testing
Certification Standards
- ISO 14644:2015 Part 1 & 2 Compliance
- USP <797> & <800> Semiannual Certification
- IEST-RP-CC006: Testing Cleanrooms guidance
- CETA (Controlled Environment Testing Association) guidelines
Comprehensive Testing Services
We provide the specialized oversight needed to ensure your controlled environment is operating at its peak efficiency and compliance.
Airborne Particle Characterization
Using calibrated laser particle counters, we verify the concentration of airborne particles at various locations within your cleanroom. This data is statistically analyzed to determine compliance with ISO Class 1 through ISO Class 8 requirements, providing a clear baseline for your environmental control performance.
HEPA/ULPA Filter Integrity Testing
A single leak in a HEPA filter can compromise an entire cleanroom. We conduct aerosol challenge testing (DOP/PAO) to ensure that your filtration system is free of leaks and that the filter-to-housing seals are intact, maintaining the barrier between clean and unconditioned air.
Airflow Visualization & Recovery Testing
How quickly can your cleanroom recover from a contamination event? We conduct recovery tests (cleanup time) to measure the facility's ability to return to its specified particle count after a challenge. Additionally, smoke studies visualize the laminar airflow patterns, identifying stagnant zones or turbulent air that could trap contaminants.
Testing Priorities
- Accuracy of technical data
- Repeatability of results
- Unbiased reporting
- Regulatory audit readiness
Our Core Assets
- NIST-traceable instrumentation
- CETA-certified technicians
- Full digital reporting
- Fast turnaround times
Formal Certification Reports
At the conclusion of our testing, you receive a comprehensive certification report that includes all raw data, statistical analysis, and a signed statement of compliance. This document is a critical asset for your facility logbook, ready to be presented during ISO audits or FDA inspections.
Schedule Your Semiannual Certification
Is your cleanroom due for its periodic validation? Contact our testing team today to schedule your certification and ensure your facility remains in a state of controlled compliance.
SCHEDULE CERTIFICATIONNeed an Independent Validation Audit?
CleanTech Facility Services provides the technical data and signatures needed for your facility compliance logs.