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Pharma grade packaging materials

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Venkateshkini

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Posted 07 May 2021 - 05:41 AM

Hi all, currently we are having a packaging material industry (supplying for food industry). We clean laminates using ambient quality air. We are planning to produce pharma grade packaging materials (Laminates, PE lines, Woven sacs etc). Is there any standard requirement for air that comes in contact with materials during cleaning ? Also it would be great help if any one gives other standard requirements for a pharma packaging material industry



Scampi

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Posted 07 May 2021 - 11:54 AM


Please stop referring to me as Sir/sirs


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TimG

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Posted 07 May 2021 - 01:52 PM

Good morning Venkate! If you are going to be looking into supplying packaging for the USP-NF sector it might be worth it to look into getting a USP-NF Pharmacopeial sub for someone in your organization. We provide several excipient ingredients, and it's worth it to go right to the source to get standard information. <659> has info on the packaging standard for USP-NF, but I didn't see in a quick glance the requirements for cleaning air. The standards are huge, you might have to search through for a bit once you have access.



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