Cleanroom Management in Pharmaceuticals and Healthcare, 2ND EDN – NEW 2017 EDN


Book by admin

Edited by Tim Sandle and Madhu Raju Saghee.
ISBN 978-0-9573491-6-2 (Hb) ISBN 978-0-9956666-0-3 (Pb)

Product Description

Everything you need to know about the operation and management of cleanrooms.

In 26 Chapters and over 600 pages this book provides a unique tool to help you achieve regulatory compliance. It first creates a foundation in history and established practice and then helps you understand how state of the art technology and engineering solutions can deliver the best practice and so provide reliable systems performance.

Since the first edition of this book in 2013 there have been many changes to the approach and methods for cleaning and certifying cleanrooms, most notably the revisions to Parts 1 and 2 of the ISO 14644 series of global cleanroom standards. In addition to setting out the principal changes in these revised standards, many of the other chapters in the book have been updated to reflect their requirements, bringing current practices and Good Manufacturing Practice regulations up-to-date. The book also details the leading international cleanroom requirements and regulations: U.S., FDA, EMA, and ISO. Many of the authors share best practice guidance.

This updated edition will prove an essential resource to all practitioners involved in the operation and management of cleanrooms.



“Highly recommended for the shelf of any cleanroom manager, engineer, microbiologist quality assurance manager – the indispensable guide to cleanrooms and cleanroom management”

Victor Grayson, Sterility Assurance Office, Bio Products


“The most up-to-date and all-embracing publication covering the complete aspects of cleanroom management within the pharmaceutical and healthcare industries. Contains all the necessary information in the one publication”

Enda McKeon, Elanco, Ireland



  1. Introduction

by Tim Sandle and Madhu Raju Saghee

  1. History and development of cleanrooms

by Tim Sandle

  1. Cleanroom standards and GMP requirements

by Mark Hallworth

  1. Design and construction of pharmaceutical cleanrooms

by Alexander Fedotov

  1. Air handling systems for the protection of pharmaceutical manufacturing processes

by Hans Schicht

  1. Cleanrooms in hospitals

by Alexander Fedotov

  1. Commissioning and qualification of cleanrooms

by Kevin Beauchamp and Miroslav Tonovski

  1. Cleanroom certification and ongoing compliance

by Tim Sandle and Madhu Raju Saghee

  1. Fundamentals of pharmaceutical isolators

by Brian Midcalf, John Neiger and Tim Sandle

  1. The choice of isolators: A risk-based decision

by Didier Meyer

  1. Validation concepts in pharmaceutical aseptic application isolators

by Rajesh Thempadiyil

  1. Risk-based product and occupational exposure control in multi-product facilities

by Julian Wilkins

  1. Future of aseptic processing

by James L Drinkwater

  1. Aseptic process simulations/media fills

by Marco Budini

  1. Microbial risk management during aseptic manufacture

by Tim Eaton

  1. Airflow studies and airflow mapping

by Tim Sandle, Marco Budini and T Rajesh

  1. Cleanroom contamination sources and control measures

by Eric Strauss

  1. Particle counters and particle counting

by Tony Harrison

  1. Environmental monitoring in cleanrooms

by Tim Sandle and Madhu Raju Saghee

  1. Cleaning and disinfection practices

by Tim Sandle and Madhu Raju Saghee

  1. Cleanroom clothing

by Matts Ramstorp

  1. Quality assurance in hospital pharmacies

by Richard Bateman

  1. Building Management Systems for cleanroom process parameters monitoring and control

by Sunil Chand Singhai and Rajesh Thempadiyil

  1. Energy management and sustainable cleanrooms

by Nigel Lenegan and Ulla Thomsen

  1. Auditing cleanroom operations

by Tim Sandle and Madhu Raju Saghee

  1. Developments in cleanroom technology

by Tim Sandle and Madhu Raju Saghee


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