Operon Strategist is a consulting company for medical device industry, primary packing material manufacturing industry & pharmaceutical industry. (Medical device consultant, primary packing material consultant, pharmaceutical consultant)
Manufacturers of medical devices like orthopaedic implants, disposables and other medical devices, primary packing material & various pharma products have to design their manufacturing unit to meet cGMP requirements & other regulatory requirements.
Operon Strategist in consultation with the client determines the bio-burden & sterility 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.
This will ensure the smooth transition during audits from regulatory bodies & customers. The layout is prepared by our Auto-CAD expert based on inputs from the client & their architect/civil engineer.