Pharmaceutical Science

Cleaning & Sterilization

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Sterilization Validation and Routine Operation Handbook (2001): Radiation

Anne F Booth
September 20, 2017

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...

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

Syed Imtiaz Haider
May 24, 2010

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

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

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

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...

Microbial Contamination Control in the Pharmaceutical Industry

Luis Jimenez
August 30, 2004

This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and...

Fluid Sterilization by Filtration

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)

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

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...

Validated Cleaning Technologies for Pharmaceutical Manufacturing

Destin A. LeBlanc
February 28, 2000

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more...

Cleaning Validation: A Practical Approach

Gil Bismuth, Shosh Neumann
January 31, 2000

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical...

Sterilization of Medical Devices

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...