Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations, Second Edition is a comprehensive guide that navigates the complex world of pharmaceutical sterilisation. This new edition is updated to reflect the latest standards and regulations, ensuring the book remains aligned with current approaches. The book also explores emerging sterilisation methods, providing readers with the most up-to-date techniques in the field. Additionally, the inclusion of new case studies offers practical examples that aid in the understanding and application of these sterilisation methods. The failure to control any microbial challenge within a process or product can lead to a contaminated marketed product, potentially causing harm to patients. Hence, sterilisation is of critical importance to healthcare and the manufacturing of medical devices and pharmaceuticals. This edition covers a wide range of topics including sterility, sterilisation and microorganisms, pyrogenicity and bacterial endotoxins, regulatory requirements and good manufacturing practices, and different sterilisation methods such as gamma radiation, e-beam, dry heat, steam, gas, vapour, filtration, and new sterilisation techniques. It provides a thorough examination of sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, container and packaging design, and cleanroom environments. The new edition also introduces substantial additions such as X-ray sterilization, liquid-phase sterilization, ultraviolet light, supercritical gases, and sterilisation assurance governance. Each chapter has been updated to reflect the latest changes in the field. "Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals: Technology, Validation and Current Regulations" is an indispensable resource for those involved in the manufacturing of sterile products. Its comprehensive coverage of sterilisation methods, combined with practical case studies, provides readers with a robust understanding of sterilisation technology and its application. The book will be of great value to those in pharmaceuticals, healthcare, and medical device manufacturing, providing them with the knowledge to ensure their products are safe and compliant with current standards and regulations.
