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 the unidirectional flow of man & material, prevention of cross-contamination, correct assignment of cleanroom 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.
Operon Strategist is Provide Medical Device Turnkey Project Consulting Services For Manufacturing Plant Layout Design, Clean Room Design, and Process Validation.
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.