Sterility Testing of Pharmaceutical Products

The central argument of the book is that control of the process and environmental control are considerably more important guarantors of sterility than the questionable comfort gained from a 'pass' result at the end of the incubation of a sterility test.

This book balances theoretical, and sometimes philosophical, discourses about the nature of sterility and the conceptual problems of microbial viability with sound practical guidance on how to validate the sterility test, problematic products as well as solutions on how to control the environment and review manufacturing process parameters, while navigating the regulatory minefield.

The aim of the book is to present the sterility test as a final product release test as seen in the past, the present and with a view towards the future and is aimed at quality assurance personnel, production staff, microbiologists, students and those with an interest in medicinal products.

1 - Sterility 2 - History of the Sterility Test 3 - Sterility Test Regulations 4 - Sterility Test: The Pharmacopeia Culture Based Method 5 - Practical Approaches to Sterility Testing 6 - Controlled Environments for Sterility Testing 7 - Culture Media for the Sterility Test 8 - Rapid and Alternative Methods for Sterility Testing 9 - Investigating Sterility Test Failures 10 - Auditing Sterility Testing 11 - Evaluating the Sterility Test 12 - Alternatives to Sterility Testing: Parametric Release 13 - Final Product Release 14 - The Sterility Test and Sterile Products: Thoughts on Definition and Application