6.3 Infrastructure Requirements


I am currently in the process of documenting our infrastructure requirements, and I have a question that might sound a little silly. But first, here's a little background.

We are a small company who is the manufacturer of a class two cryosurgical medical device that includes a canister filled with a combination of refrigerated gases and accessories to use with the canister. All of the components that make up the finished device i.e., the canister and the accessories, are outsourced. So, essentially all we are doing is storing and then putting the canister and the accessories together in a box to make finished product that is then ready for distribution.

All that being said, my issue is this: given that its such a simple process, with literally nothing involved besides a person to put the kit together, I'm having trouble listing infrastructure requirements. Do I include the tables used to assemble the kits? The shelves used for finished product? The building?

I'm also having the same issue with documenting the work environment. The product is not assembled in a clean room and is not a sterile product (side note- 6.4.2 Contamination Control only applies for clean room/sterile products, correct?). Just because of the nature of the product, there really aren't any specific requirements for the work environment aside from maybe electricity to be able to see what you're doing :ROFLMAO:. Again, I realize this might sound silly, it's just difficult to find any guidance because most companies have a very complex process when ours is extremely simple.

Please be nice, I am new to this and still learning. :)

Billy Milly

Quite Involved in Discussions
It depends on the product's intended use. Is it used in a surgical room, in hospital rooms, at home? How clean does it need to be? You say clean room is not needed, maybe pest control is? Cleaning of the work area? Cleaning of work surfaces?
If you do not have a clue on the "how clean", ask your suppliers.

Just something general to kick you off :)


Quite Involved in Discussions
Assuming your company is not okay with manufacturing in a dirty tire shop, there are always some infrastructural requirements for your product. Plenty of medical devices are not made in an ISO 7 or 8 cleanroom, but that does not mean they should be manufactured in anything other than a clean room. Up to you to define what exactly that means. Further, are there ESD requirements, workstations that need to be setup a certain way, human factors which could cause manufacturing issues, pest control needs to have a program established where someone (can be internal) is routinely evaluating your facility for potential issues, in addition to the point that @Billy Milly made, use these are thoughts to drive what your ideal manufacturing environment looks like.
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