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 desired, different classes of clean rooms are constructed ranging from Class 1 to Class 100,000 as per the US FED STD 209 E clean room standards.
Operon Strategist in consultation with the client determines the bio-burden & sterilization requirements for the medical device.
Clean Room Conceptualization
Accordingly the clean room classification for each room is determined. The classified areas are also reflected in the factory layout design to give a better clarity to the client about classified & unclassified areas.
Operon Strategist coordinates with clean room providers to convey the exact requirements to prevent any miscalculations while designing the clean room.