Clean Air and Containment Review





Editor: John Neiger
Publisher: Euromed Communications
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Journal contents list

< Issue 45 | Issue 46

Issue 46: 2021/Number Two

Main features
COP26
Jamie Young
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Abstract

As the world reviews the actions necessary to curtail the global rising of temperatures at COP26, the pharmaceutical and cleanroom industries must also consider their role in the effort to collectively create a more sustainable future for our planet. This article overviews the key outputs of COP26 whilst highlighting various points of progress in the life science sector.

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Cleanroom Testing and Monitoring – Chapter 1: Introduction
W Whyte
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Abstract

This article is the first of a short series of extracts from Bill Whyte’s new book Cleanroom Testing and Monitoring and is reproduced here with the kind permission of the author, Bill Whyte, the publisher, Euromed Communications, and the owner of the copyright, the Cleanroom Testing and Certification Board – International (CTCB-I). The objective in publishing these extracts is to give readers a flavour of the content and depth of the book which is recommended as a comprehensive textbook and an essential reference for cleanroom managers, cleanroom test engineers, cleanroom service engineers, cleanroom designers and specifiers and anybody who is concerned with cleanrooms. All too often testing and monitoring are insufficiently considered until an installation is physically complete. If you design and build an installation to achieve a certain performance, it is essential that you understand and plan at an early stage for how that performance will be verified and monitored throughout the life of the installation.

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Choosing the most suitable particle sample point locations in the cleanroom
Mark Hallworth
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Abstract

As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.). The answer is not always straightforward. There are several guidance documents that offer advice on what processes need to be monitored, along with advice on suitable distances from the process being monitored. The goal of this article is to identify the considerations, establish the most suitable locations for monitoring a process, and build a scientific rationale for that decision.

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Known Unknowns: Known Knowns and COVID mitigation
Andrew Watson
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Abstract

The regulatory landscape for pharmaceutical manufacturing has been in a state of flux for a couple of years now as the much-discussed revision to GMP Annex 1 has undergone numerous consultations. Its publication is anticipated for early 2022 and will herald a notable shift in the requirements for environmental monitoring within the industry. The most obvious changes being a focus on continuous monitoring and a change to the limits for grade A spaces.

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Regulatory reflections
Continuous environmental monitoring (EM) and Annex 1
Andy Whittard
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Abstract

The regulatory landscape for pharmaceutical manufacturing has been in a state of flux for a couple of years now as the much-discussed revision to GMP Annex 1 has undergone numerous consultations. Its publication is anticipated for early 2022 and will herald a notable shift in the requirements for environmental monitoring within the industry. The most obvious changes being a focus on continuous monitoring and a change to the limits for grade A spaces.

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Conference report
Cleanroom Technology Conference 2021
Sophie Bullimore
Book Review
Cleanroom Testing and Monitoring by William Whyte
Reviewed by John Neiger
Letter
Comments on a recent article on bio-decontamination with vapourised hydrogen peroxide
Tim Coles
News
Events and Training courses
Life-lines