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Overview EN ISO 13408-7:2015 (ISO 13408-7:2012) addresses aseptic processing for medical devices and combination products when terminal sterilization is not possible and the conventional media-fill a…
Overview ISO 13408-7:2012 - Aseptic processing of health care products, Part 7 - provides requirements and guidance for alternative process simulations used to qualify aseptic processing of medical d…