Operon Strategist is a consulting company for medical device industry, primary packing material manufacturing industry & pharmaceutical industry. We are Provide 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.
Manufacturing Unit Setup Design Consulting Services For orthopedic implant Manufacturing Industry, surgical instrument manufacturing, dental instrument manufacturing Industry, implant-manufacturing, implantable-moulding, instrument-manufacturing, endodontic-instrument, diagnostic-instrument manufacturing Industry, equipment manufacturing, sterilizers manufacturing, syringe manufacturing, Disposable Plastic Syringes. Operon Strategist help manufacturers of these industries to design layout as per all international & national guidelines to make your manufacturing unit compliant with all regulatory requirements.
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.
Our services of Manufacturing Site Conceptualization project include Following stages:
Facility Layout & Design
The layout is prepared by our Auto-CAD expert based on inputs from the client & their architect/civil engineer. We provide complete turnkey solutions for manufacturers as well as customized packages as per the requirements of the client.
Clean Room Design
Operon Strategist in consultation with the client determines the bio-burden & sterility requirements for the medical device.
In addition to designing the layout, we also provide qualification & validation services for the utilities, machines & equipment required for the operation of the manufacturing unit.
Equipment & Utilities Validation
1.Facilities,Utilities & Equipment Validation For Medical Device.
2.Equipment & Utilities Validation For Primary Packaging.
Operon Strategist is a primary packaging consultant for Facility Equipment and utility system qualification. Also for validation projects for pharmaceutical and Medical device companies including related process validation.
Equipment Selection & Sourcing
It is Key Parameter for Manufacturing unit &utilize them to Meet national & International level.
Name:Equipment & Utilities Validation