Based mostly on the FDA Top quality System Legal guidelines, producers ought to make certain that "device packaging and supply containers are designed and constructed to protect the device from alteration or damage by means of the customary circumstances of processing, storage, coping with, and distribution." As specific as this assertion is, the FDA does not current instructions on the easiest way to acquire their necessities. Validating Medical Packaging demystifies the validation course of for medical device packaging by providing specific examples and templates for creating and sustaining a validation file.
In regards to the author:
Ronald Pilchik has over 30 years of experience inside the healthcare manufacturing business. As principal of the Techmark Group, he provided consulting suppliers to quite a few multinational producers on selecting, creating, and validating medical packaging appropriate with their sterilization requirements. He has been chairman of the healthcare packaging a part of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Assortment on medical device packaging.
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