Validation & Measurement
We perform various types of clean room test and validation services like filter test, particle counting, microbial air sampling, air flow measurements and VHP sterilization.
Validation/Projects
- Validation plan
- DQ / IQ / OQ / PQ Validation document for clean rooms
- Validation/Function control of operation theatres and CSSD
- Risk analysis
- Traceability matrix
- Development of URS
- Preliminary studies
- Requests for clean rooms, clean air equipment as well as protective ventilation
Measurement
- Filter Test / Leak Test of HEPA filter in ceiling diffuser / filter boxes
- LAF benches / safety benches, Operational ceiling
- Particle measurement / Clean room classification
- Recovery test
- Airflow measurement
- Air turnover measurements
- Air velocity measurements
- Press / Air direction controls
- Visualization of air movements
- Control / Calibration of differential pressure
- Function control of LAF units, fume cupboards, biosafety cabinets and other protective device
Sterilization
6-log sterilization with hydrogen peroxide in gaseous form of:
- Clean room
- Material transfer hatches
- Isolators
- Operating theatres
- Isolation rooms
- Biosafety labs
- Filter cabinets
Other services
- Replace HEPA filter and prefilter
- HVAC adjustment of differential pressure
- Development of methods and procedures
- Inspections
- Advice on clean rooms and operating theatres