In a new book 'Sterility Testing of Pharmaceutical Products', Tim Sandle proposes 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.
Available from the PDA Bookstore, save 20% by ordering before 30 Sept - Click here for more information
