Sterility Testing of Pharmaceutical Products
Publisher: PDA / DHI
Published: 2013
Place of publication: Bethesda, USA
Language: eng
Format: Hardcover
Number of pages: 379
Description: 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.
Table of contents: title: Sterility; title: History of the Sterility Test; title: Sterility Test Regulations; title: Sterility Test: The Pharmacopeia Culture Based Method; title: Practical Approaches to Sterility Testing; title: Controlled Environments for Sterility Testing; title: Culture Media for the Sterility Test; title: Rapid and Alternative Methods for Sterility Testing; title: Investigating Sterility Test Failures; title: Auditing Sterility Testing; title: Evaluating the Sterility Test; title: Alternatives to Sterility Testing: Parametric Release; title: Final Product Release; title: The Sterility Test and Sterile Products: Thoughts on Definition and Application