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 orthopedic 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 determine. The classified areas are also reflected in the factory layout design to give a better clarity to the client about classified & unclassified areas.Clean Room Design Consulting Services In Australia, Brazil, Bangladesh, Comoros, Costa Rica, Canada, Central Asia, Colombia, Egypt, Iceland, India, Indonesia , Nigeria , New Zealand , Oman , Peru , Qatar , Israel , European Union , Europe & Middle East , Hong Kong , Kenya , Korea , Kuwait , Liberia , Malaysia , Mexico , Mauritius , Saudi Arabia , Singapore , South & Central Asia , South Africa ,Southeast Asia & Pacific , Sri Lanka , Switzerland , Russia , Singapore , Turkey , Thailand , Ukraine , United Arab Emirates.
Operon Strategist coordinates with clean room providers to convey the exact requirements to prevent any miscalculations while designing the clean room.
This will ensure a 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.