Medical Device Layout Design
Medical Device Turnkey Project ConsultantOperon Strategist is a Leading regulatory & quality assurance consultant for Medical Device & primary packaging manufacturers. Working out of Pune, India, Operon Strategist has a global presence with an international client base.
Medical Device Plant Layout Design ConsultantWe are a leading service provider of facility plant setup , medical device unit design,pharma setup and clean room design facility plant setup services.
Medical Device Process ValidationProcess Validation For HVAC validation , Equipment validation , Process validation , Facilities validation , Cleaning validation , Analytical method validation.
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.
We study the requirements of the client, the product details & the manufacturing flow process to develop an adequate layout which meets regulatory requirements such as unidirectional flow of man & material, prevention of cross contamination, correct assignment of clean room classification among other requirements.
In addition to designing the layout, we also provide qualification & validation services of the utilities, machines & equipment required for the operation of the manufacturing unit.
We help Medical Device Manufacturers design their manufacturing unit layout to meet national as well as international requirements including GMP, Schedule M, Schedule MIII requirements.
We Advise clients on how to utilize the available space to the best extent without affecting the quality of production.We also help manufacturers in the selection & sourcing of the right equipment needed for production.