Manufacturing of medical devices
We are into manufacturing of medical devices (plastics), Is it necessary to monitor temperatures and humidity at warehouse of plastic granules/polymers
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Monitoring temperature and humidity at warehouse (plasti granules/polymers) depends on the symbols that are on the packaging of plastic granules. If there is a symbol for temperature range specifically stated (eg. 5-30C), than you need to monitor temperature. If there is no such a symbol, you are not obliged to monitor this elements. According to the ISO 13485:2016 clause 7.5.11 Preservation of product, you must protect your material from alteration, contamination or damage when exposed to expected conditions.
We have a procedure for Warehouse in our toolkit. The content you can see on the following link:
https://advisera.com/13485academy/documentation/warehousing-procedure-iso-13485-2016/
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Feb 25, 2020