Clean Room Validation
We undertake complete clean room validation documentation of clean room equipments and clean rooms. The clean room validation process comprise of the following steps.
- Particle counting.
- DOP test. Filter leak test
- Air flow pattern
- Laminar airflow certification
- Recovery test
- Air changes
- Air balancing/ pressure balancing
- Temperature and humidity mapping
- Light intensity testing for clean room validation
FAQs
Cleanroom validation is a process of testing and certifying that a controlled environment meets required cleanliness, airflow, and contamination control standards such as ISO 14644 and GMP.
It ensures the cleanroom performs as designed, maintaining the required environmental conditions for pharmaceutical, biotech, and electronics manufacturing.
Typically, cleanrooms are validated annually or after major maintenance, renovation, or equipment replacement that could affect cleanliness performance.
Key parameters include air change rate, particle count, temperature, humidity, air velocity, pressure differential, and HEPA filter integrity.
Cleanroom validation follows ISO 14644, GMP (Good Manufacturing Practices), and regulatory requirements from agencies such as WHO and EU GMP Annex 1.
Validation should be carried out by certified professionals with the proper instruments and knowledge of ISO and GMP cleanroom standards.
A complete validation report is issued, including test data, calibration certificates, and compliance confirmation with international standards.
