Pharmaceutical Science

Cleaning & Sterilization

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Revival: Sterilization Validation and Routine Operation Handbook (2001): Radiation

1st Edition

Anne F Booth
January 28, 2019

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and...

Disinfection and Decontamination: A Practical Handbook

1st Edition

Jeanne Moldenhauer
December 05, 2018

This book describes various methods of decontamination and how the methods work. There is a discussion of the various cleaning and disinfection methods utilized, along with details of how to qualify these methods. It also describes new technologies that may be useful in the battle for...

Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries

1st Edition

Syed Imtiaz Haider
July 31, 2018

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them...

Clean-In-Place for Biopharmaceutical Processes

1st Edition

Dale A. Seiberling
October 15, 2007

An invaluable source instruction on the principles, instrumentation, design, implementation, operation, and maintenance of an effective clean-in-place system (CIP), this guide illustrates best practices and successful applications of CIP in both pharmaceutical and biotechnology facilities....

Disinfection and Decontamination: Principles, Applications and Related Issues

1st Edition

Gurusamy Manivannan
October 04, 2007

In the battle between humans and microbes, knowledge may be not only the best weapon but also the best defense. Pulling contributions from 34 experts into a unified presentation, Disinfection and Decontamination: Principles, Applications, and Related Issues provides coverage that is both...

Environmental Monitoring for Cleanrooms and Controlled Environments

1st Edition

Anne Marie Dixon
November 02, 2006

A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in...

Cleanroom Microbiology for the Non-Microbiologist

2nd Edition

David M. Carlberg
October 28, 2004

Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist, Second Edition introduces principles of microbiology. It explains the consequences of microbiological contamination, what...

Microbiological Contamination Control in Pharmaceutical Clean Rooms

1st Edition

Nigel Halls
June 25, 2004

Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it...

Fluid Sterilization by Filtration

3rd Edition

Peter R. Johnston
December 15, 2003

Completely revised and updated, Fluid Sterilization by Filtration, Third Edition discusses the use of gas and fluid filtration systems in sterilization technology. Packed with information useful to both the novice and the expert, it includes line-drawing illustrations, filtration setups, and plots...

Quality Rules in Sterile Products: Revised American Edition (5-pack)

1st Edition

John Sharp
June 30, 2002

This newly-revised and specifically American edition of the best-selling original is the perfect introduction Good Manufacturing Practice (GMP) as it relates to manufacturing sterile products. Quality Rules in Sterile Products Manufacture is the ideal training resource for workers recently hired...

Radiation Sterilization for Health Care Products: X-Ray, Gamma, and Electron Beam

1st Edition

Barry P. Fairand
September 26, 2001

Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, this book provides the latest developments in radiation technology in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as...

Sterilization of Medical Devices

1st Edition

Anne Booth
November 30, 1998

This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of...