We can audit and validate plans and design specifications according to GMP and other existing applicable technical laws and regulations.
Validatable items:
- Static pressure difference;
- Illuminance;
- Efficient filter leak detection;
- Air speed and volume;
- Air flow pattern;
- Ventilation rate;
- Settling microbe;
- Airborne microbe;
- Cleanliness class;
- Clean bench;
- Clean-down capability;
- Transfer window;
- Ambient temperature and humidity;
- Noise