Primary Packaging Process Validation
- Primary Packaging Turnkey Project ConsultantPrimary Packaging Turnkey project services For Plant Layout Design , Clean room conceptualization , Process Validation For Primary Packaging Manufacturing Industry
- Primary Packaging Clean Room Design ConsultantClean Room Helps in Establishing & Maintaining an Environment with a Low Level of Environmental Pollutants Such as Dust, Airborne Microbes, Aerosol Particles & Chemical Vapors.
- Plant Layout Design ConsultantPlant Layout Design For Primary Packaging , Clean Room Design , Process Validation For Primary Packaging Manufacturing Industry.
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 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 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.