The current compendial sterility test methodology has been fully harmonized for Europe, Japan and the United States for many years. In spite of having a fully harmonized test methodology, in reality, the test methodology is only effective in detecting gross contamination in a batch of product. Manufacturers are now focused on how their aseptically processed products might achieve a shortened time to product release as part of the sterility test.
To date regulatory support has not been gained to support a program of parametric release for aseptically filled products. This results in many companies looking at rapid sterility testing methods to reduce the time to release for aseptically-filled products.
In this book you will find a history of the sterility test methodology as well as detailed discussions that provide the regulatory requirements and allowances for gaining approval of rapid sterility test methods. Compendial requirements for validation and implementation of these methods in the United States and Europe are also discussed. Subject matter experts provide information on the types of methods that can be considered for aseptic sterility testing and discuss issues such as the statistical methods used to validate these methods, especially since many of the new technologies are superior to the conventional methods. Last, there are a substantial number of case studies describing how various companies have approached selecting, validating and implementing new methodologies for sterility testing at their site.