Work Instruction for Validation of Packaging to EN ISO 11607-2 Requirements

I

ISO SORRY - HAPPY

Dear all,
I absolutely love this forum. I found a lot of guidance here :)
I need help. Work instruction in general is needed form validation of packaging (paper/ foil). Simple gauze product are packed manually on some old simple machines in clean room ISO class 8.
I am now ISO sorry from audit and need very fast work instruction. I would appreciate if someone can share some according to EN ISO 11607-2 so I can prepare our fast.
Thank you all very much in advance
 

yodon

Leader
Super Moderator
I'm not sure I understand your question. Packaging validation is (generally) a one-time event to confirm that the packaging adequately protects the product via normal shipping (tested to applicable standards).

Work Instructions (WI) describe how the employees on the line operate the equipment / use the materials to perform the packaging operation (repeatedly, consistently). The WI would be quite unique to your operation, your operator's needs, your equipment.

So are you asking for a packaging validation protocol or a work instruction on how to perform packaging?
 
I

ISO SORRY - HAPPY

Hi Yodon,
Yes I did not specified exact what is necessary for us .
Yes I need Packaging validation protocol.
Can you help?
 

yodon

Leader
Super Moderator
I have relied on external testing. I don't have, for example, shake tables.

Here in the US, FedEx can do testing and they have an internal protocol, ISTA-6-FedEx that includes vibration and drop testing. This has worked well for us.
 
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