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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.
Book written in September, 2013
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Format: PDF (1 file 3.14 MB)
Table of Contents:
Click here to download >>>Detailed Table of Contents
- History of the Sterility Test
- Sterility Test Regulations
- Sterility Test: The Pharmacopeia Culture Based Method
- Practical Approaches to Sterility Testing
- Controlled Environments for Sterility Testing
- Culture Media for the Sterility Test
- Rapid and Alternative Methods for Sterility Testing
- Investigating Sterility Test Failures
- Auditing Sterility Testing
- Evaluating the Sterility Test
- Alternatives to Sterility Testing: Parametric Release
- Final Product Release
- The Sterility Test and Sterile Products: Thoughts on Definition and Application
Dr. Tim Sandle, Head of Microbiology at the UK Bio Products Laboratory. His role involves overseeing a range of microbiological tests, batch review, microbiological investigation and policy development. Tim originally trained as parasitologist before moving into the healthcare and then into the life sciences. Tim has over twenty-year's experience of work in the scientific and pharmaceutical fields.
In addition, Tim is an honorary consultant with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester and is a tutor for the university's pharmaceutical microbiology MS course. Tim is a chartered biologist and holds a first class honors degree in Applied Biology; a Masters degree in education; and a PhD in microbiology.
Tim serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards), and he has acted as a spokesperson for several microbiological societies. He is a committee member of the UK and Irish microbiology society Pharmig and editor of the organisation's newsletter. Tim has written over two hundred book chapters, peer reviewed papers and technical articles relating to microbiology