Facility Layout & Design For Primary Packaging:
Facility Layout & Design is an important element while setting up a manufacturing unit. While design the plant/facility layout, due consideration has to be given to the regulatory requirements, in particular, the cGMP requirements. The layout thus designed has to ensure a smooth flow of man & material through the plant.
Clean Room Conceptualization For Primary Packaging:
clean room helps in establishing & maintaining an environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.
Process Validation For Primary Packaging:
operon strategist guides manufacturers & validation service providers on the validation activity & documentation. we study the product & the production facility & accordingly design the validation master plan which outlines the validation activities to be performed & timeline for the same.