ISO 22442-3

ISO 22442-3

Medical devices utilizing animal tissues and their derivatives – Part 3:  Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (December 15, 2007).

BioScience Laboratories provides a scale down testing per ISO 22442-3 to meet ICH Guideline “Q5A Viral Safety Evaluation of Biotechnology Product Derived From Cell Lines of Human or Animal Origin”.  ISO 22442-3 specifies testing requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. 

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Virology Laboratory

BioScience Laboratories assists clients with new product development, R&D projects, marketing claims, and supporting EPA, FDA, EU, and Health Canada label claims. Combining our virology capabilities with over 23 years of experience in conducting GLP and GCP compliant studies, we can offer a start-to-finish solution. Our personnel lead by Dr. Volha Teagle…

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