Clean Room Validation Services

Clean rooms must be validated prior to operation. This process ensures that the clean room is working correctly. Specific standards set the requirements for clean room validation. These include ISO 14644-1 or FED 309E. After a clean room is validated and becomes active it must regularly be checked in order to ensure that it continues to meet initial standards. Specific standards list the time intervals at which clean rooms should be tested and the minimum requirements a clean room must meet.
Clean Room Tests / Clean Room Validation
· Air Supply and Extract Quantities
· Pressure Differential Between Areas
· Air Movement Control and Recovery
· Airborne Particle Concentrations
Optional Tests Used in Clean Room Validation
· Lighting Levels
· Temperature
· Humidity
· Heating and Cooling capabilities of the room
The microbiological, bio-technological & pharmaceutical sectors are subject to GMP requirements, with testing & validation of clean room ventilation as one of the most critical parameters. We prepare necessary protocols, perform the tests & make the final reports. Our experience with meeting the stringent requirements within the microbiological, bio-technological & pharma sectors can with advantage be transferred to other industries, such as hospitals, electronics, the food sector & the device industry.
As an independent testing and certification agency, we use only the most reliable and accurate testing instrumentation, calibrated to national standards.