by Hans van Doorne

This booklet is taken from the bestselling Microbiology in Pharmaceutical Manufacturing and provides practical advice for anyone interested in current aspects of microbiology in pharmaceutical manufacturing

by Maik W Jornitz and Theodore H Meltzer

This book is the eighth volume on the subject of various aspects of pharmaceutical filtration collaboratively written by these authors. In this book, they have established the science of pharmaceutical filtration within the wider reaches of the physical and biological disciplines so that its connection with other technical operations will be better understood.

Ordinarily, this technical pursuit is seen as being apart from the filtration activity because they are not immediately involved in its problem solving operations.

ISBN 1-933722-32-0

edited by Jeanne Moldenhauer and Margarita Gomez

This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores.

It will be of great interest to laboratory supervisors, regulatory and compliance personnel, validation specialists and professionals engaged in other aspects of pharmaceutical and biopharmaceutical manufacturing.

ISBN 1-933722-27-4

by Trevor Deeks

This book explains process understanding and what part it plays in the validation effort that is required in order to register a new product or process.

This guidebook examines the current norms and status of bioprocess validation and explains how to establish compliant process robustness, ensuring consistency and thereby assuring product quality. 

ISBN 1-933722-16-9 

by Steven S Kuwahara and Simon Xiuwei Li

Based on the authors' extensive experience working in China, it became apparent that an English translation of the Chinese GMP would be a very valuable tool for those that needed to compare them with the US GMP that are found in 21 CFR 210 and 211.

ISBN 1-933722-05-3