Primary Packaging Process Validation

  • Primary Packaging Turnkey Project Consultant
    Primary Packaging Turnkey Project Consultant
    Primary Packaging Turnkey project services For Plant Layout Design , Clean room conceptualization , Process Validation For Primary Packaging Manufacturing Industry
  • Primary Packaging Clean Room Design Consultant
    Primary Packaging Clean Room Design Consultant
    Clean 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 Consultant
    Plant Layout Design Consultant
    Plant 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.

 
 
 
 
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