Clean room helps in establishing & maintaining an environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.
Many medical devices are manufactured & supplied sterile. Some medical devices are sold unsterile but require a low bio-burden. Depending on the level of air quality desire. Different classes of clean rooms are construction ranging from Class 1 to Class 100,000 as per the US FED STD 209E clean room standards.
Operon Strategist in consultation with the client determines the bio-burden & sterilization requirements for the medical device.
Accordingly, the clean room classification for each room determine. The classified areas are also reflected in the factory layout design to give a better clarity to the client about classified & unclassified areas.
We coordinate with clean room providers to convey the exact requirements to prevent any miscalculations while designing the clean room.