Assembly and Packaging areas separation ??!!!

I do not manufacture human medical devices and am not familiar with specific regulations. Others here are so until they chime in I can give you my opinion (which may not count for much).

The only reason that I can see for separating the two areas would be to provide some difficulty in accidentally packaging incomplete devices or non-conforming devices for shipment. If you do not have an organized workflow (physical and electronic) that makes this impossible (Except for deliberate malicious intent, which nothing can prevent) you are probably better off separating the two operations. However, to save time space and money I recommend an organized 1 piece flow workspace.

 

I am also not aware of specific regulations for separate areas, but I can offer that "good management practices" (GMP) are enforced in my client sites with oversight from the Food and Drug Administration (FDA).

The document WHO Technical Report Series No. 908, ©2003 discusses practices including packaging - see pages 80-83. The focus is on controlling contamination and the mixing of parts. The document does not, however list a requirement to segregate packaging areas. Code of Federal Regulations (CFR) 21 Section 820.140 Handling similarly states "Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling."

I hope this helps!

 

I think I made my point poorly. I could find no requirement for segregated packaging areas. Indeed, we might determine that packaging may, in relevant cases, be practical within the same clean room environment as production so as to minimize the risk of contamination. This might be limited to the first or even double layer bagging, as clean bagging is available; label the items in some way to maintain traceability, even if only with printed ink on the bags. Once this is done you can move the items into a less clean room - paper labels can be affixed, then final packing into cartons after leaving the clean room so long as accurate traceability is maintained. Cleanliness and accuracy are the goals.

 

The FDA has posted warning letters to organizations. It might be helpful to use these letters as real-world examples of other people's experiences, as they are directly from the source.