Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed produc

Medical equipment, Sterile equipment, Sterilization (hygiene), Production, Clean rooms, Environment (working), Quality assurance systems, Quality management, Qu

Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in t

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are i