Independent, auditable testing and regulatory certification ensuring continuous compliance, operational longevity, and minimal plant downtime.
Regulatory bodies (FDA, EMA, WHO) demand rigorous validation documentation before any cleanroom can begin commercial production. REINWERK provides comprehensive validation services following the international Good Automated Manufacturing Practice (GAMP 5) lifecycle model.
Our certified cleanroom metrology engineers perform all on-site qualification testing with calibrated state-of-the-art instruments, providing tamper-proof audit-ready documentation and customized preventative maintenance programs.
Structured protocols establishing documented evidence that facilities and systems perform consistently according to User Requirement Specifications (URS).
DOP / DEHS aerosol challenge testing and photometer scanning to detect pinhole leaks in filter media, gel seals, and clamping frames.
Optical particle counter sampling according to ISO 14644-1:2015 at rest and in operational states for particles ≥0.1 µm, ≥0.5 µm, and ≥5.0 µm.
High-purity DI water smoke studies to document unidirectional airflow, turbulence zones, and recovery rate measurements (typically <15 minutes).
| Testing Standard | DIN EN ISO 14644-1, 2, 3:2019, EU-GMP Annex 1, VDI 2083 |
| Instrumentation | NIST-traceable calibrated optical particle counters, hot-wire anemometers, and aerosol generators |
| Aerosol Challenge | DEHS (Di-Ethyl-Hexyl-Sebacat) or Emery 3004 / PAO |
| Air Velocity Range | 0.1 m/s to 30 m/s with ±2% accuracy |
| Report Delivery | GMP-compliant audit-ready digital certificates and comprehensive protocol dossiers |
| Service Intervals | Quarterly, bi-annual, or annual re-certification contracts |
According to ISO 14644-2:2015, airborne particle concentration testing should be demonstrated at least once every 12 months for ISO 6 through 9, and at least every 6 months for ISO 5 and cleaner. Filter integrity and differential pressure should be verified continuously or on a scheduled schedule.
If a minor leak is detected, it can often be repaired using FDA-approved silicone-free cleanroom patch sealant within standard surface area allowances. If the leak exceeds permissible limits, REINWERK technicians immediately replace the filter element with a factory-tested replacement.