Facility Layout Design is the primary step for manufacturing plant setup. Medical Device Manufacturing plant must be compliant with the rules given by respective regulatory bodies like USFDA, CDSCO etc.
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.
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.
Layout designing helps to determine the space requirements for various processes and their associated equipment/machinery. We incorporate design in such a way to ensure unidirectional flow of man and material and prevent cross-contamination. We also consult manufacturers on plans for future expansion or change & accordingly design the facility layout. We incorporate efficient space utilization for maximum layout effectiveness in our designs.
The best demonstration of the compliance can be achieved by the right design. The right design minimises the manual errors and requires the least effort in controlling the activities. Hence the right design of product, manufacturing site and the system plays the vital role in the quality of products and take care of the future issues that may crop up because of poor designs.
There are various expectations “implied“ and “expected to be understood” laid down by the regulators across the world. Some of the expectations can be well understood and compiled in the facility based on the experience of the regulatory audits. In the case of the existing facility, it is very important to know the facility compliance before applying for the regulatory audits to avoid the irreversible losses at the end of the facility audit. Our facility designs are appreciated by various regulatory for their compliances and the for minimal man and material movements and products segregations.
Need help !Regulatory Aspects of the clean room are comprehensively taken care by us.
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 the clean room classification among other requirements.
We help Medical Device Manufacturers design their manufacturing unit layout to meet national as well as international cGMP requirements.
While meeting the regulatory expectations, we balance the space availability, use of the optimum space and minimise the man and material movement to the maximum extent.