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Assembly and Packaging areas separation ??!!!

Discussion in 'Medical Devices (21 CFR Part 820)' started by Abdullah, Dec 22, 2015.

  1. Abdullah

    Abdullah Member

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    Dear All,,,
    Regarding to the manufacturing of Medical Devices; is it a must (by any of the well known authorities such as FDA or WHO,...) to have areas for the assembly of the products that are completely separated than the required areas for the packaging ??!!!


    Looking forward to hearing from you ^_^.
     
  2. Bev D

    Bev D Moderator Staff Member

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    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.
     
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  3. Ronen E

    Ronen E Well-Known Member

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    I am not aware of a regulation dictating just that.
     
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  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    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!
     
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  5. Abdullah

    Abdullah Member

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    Thanks for all,
    The point is we have a manufacturing line for the medical devices (i mean pressure meters , thermoneters. And so on) but we do not have a physical separation between the manufacturing line (in which we do lot of activities on the board) and the packaging line (which is secondary packaging). And we are preparing for a FDA audit, so that why i need to ask such question. Because the first thing they will ask about it is the separation between these areas .
     
  6. Vintage Goose

    Vintage Goose Active Member

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    The only thing I can think of is if the manufacturing is in a clean room, then you may need a separate area for packaging to prevent product being contaminated with card and dust.
     
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  7. Candi1024

    Candi1024 Well-Known Member

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    We have segregated ESD areas (marked by tape on the floor) and we have a dedicated packaging area, but they are directly next to each other.
     
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  8. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    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.
     
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  9. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    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.
     
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  10. Pads38

    Pads38 Member

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    We had an "Observation" from our latest FDA audit about packaging materials in our production area.
    But this, as Candi also mentions, was an ESD area problem (cardboard - the packaging - is not ESD safe).
     
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