Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and...
Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marke...
This book provides an introduction to cleanrooms and clean air devices in GMP environments. The book explains what cleanrooms are, the contamination risks, key design features, and the requirements for classifying and operating them. The book includes detail on the 2015 update to the international cleanroom standard ISO 14644 (Parts 1 and 2).
This book provides an introduction to cleanrooms and clean air devices in GMP environments. The book explains what cleanrooms are, the contamination r...
