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Medical Device Packaging Manufacturing - How should product be stored on the pallet

C

channelr

#1
Hello, I work for Medical Device Packaging Mfg.- we make the rollstock that is used to make lids for medical device packaging. How should product be stored on the pallet? We currently wrap the roll in plastic, and put on the pallet. We were written up in a recent audit for this and I cannot find a regulation that states this. There is still a barrier of plastic wrap or a box with plastic wrap inside between the product. I would like to know for in-process raw material as well as finished goods. If a slip sheet is required (which I thought it was) it should be plastic correct and not cardboard? Thanks for the help!:agree:
 
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Ronen E

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#2
Re: Medical Device Packaging Manufacturing - How should product be stored on the pall

Hi,

A few clarification questions:
1. What was the audit's context - 2nd party (customer) are 3rd party (certiication/regulatory)?
2. To what standard where you audited?
3. What was the exact requirement you were written up against?
4. What exact medical devices are being packaged with those lids? Is it sterile barrier? Are the lids being applied inside cleanrooms (if so, what level cleanrooms)?
5. Do you have explicit contractual (customer) obligations regarding rolls packaging and/or cleanliness?
 
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