Pharmaceutical Science

Cleaning & Sterilization

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Sterilization Validation and Routine Operation Handbook (2001): Radiation

Anne F Booth
August 31, 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
July 30, 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...

Cleanroom Microbiology for the Non-Microbiologist

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...

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...

Microbiological Contamination Control in Pharmaceutical Clean Rooms

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...

Isolation Technology: A Practical Guide, Second Edition

Tim Coles
May 27, 2004

The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best...

Sterile Product Facility Design and Project Management, Second Edition

Jeffrey N. Odum
March 29, 2004

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility...

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...

Conferences

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