Clean Air and Containment Review





Editor: John Neiger
Publisher: Euromed Communications
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Journal contents list

< Issue 49 | Issue 50

Issue 50: 2024/Number One

Main features
Operating a Cleanroom: Risk Management and Control of Contamination
W. Whyte
Abstract →
Abstract

This article is a reproduction of Chapter 18 of the Third Edition of Cleanroom Technology, Fundamentals of Design, Testing and Operation by Bill Whyte by kind permission of the author. The Third Edition of Cleanroom Technology, which was published independently by the author in 2023, was reviewed by the editor in CACR49. The main sections in the reproduced chapter explain how to identify sources and routes of contamination, how to carry out a risk assessment of sources of contamination with examples, how to control and reduce the risk of contamination, how to establish a monitoring programme, how to verify and reappraise the CCC (cleanroom contamination control) system, and what the basic requirements are for documentation and staff training.

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Standards
ISO Technical Report 14644-21 published to support ISO 14644 parts 1 and 2
John Hargreaves and Andrew Watson
Standards (comment)
Isokinetic sampling of airborne particles in cleanrooms
W. Whyte
Main features
Theoretical and experimental performance of a sample tube for particle counting
Olivier Brouste
Abstract →
Abstract

The latest 2022 revision of EU GMP Annex 1 1 introduced the requirement to qualify particle counters, including sampling tubing (ref. Annex 1, Clause 5.9). It is therefore now necessary to assess particle losses in sampling in order to understand the quality of particle measurements in the context of monitoring or of classification. This requirement of Annex 1 is supported by the release of ISO/TR 14644-21 2 – Part 21: Airborne particle sampling techniques which brings clarification to the application of airborne particle sampling techniques.

The author's company has been working for several years on the validation of sampling lines to offer particle deposition measurements which are metrologically traceable and accurate in terms of the theoretical equations which control these deposition phenomena. The results presented in this article demonstrate that an experimental approach in the laboratory, by modelling a real line, makes it possible to quantify the loss of aerosol and to optimize the overall geometry of sampling lines before implementation

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Cleanroom ceiling systems
Zareer Cursetjee
Abstract →
Abstract

There are many considerations when designing a cleanroom ceiling system and this article sets out to list and explain the most important. Ceilings can be modular or stick-built and assembled onsite or offsite. They need to take into account access to components such as filters and lighting, whether this access will be from below or above, whether the ceiling needs to be walkable and what types of loads need to be supported from the ceiling grid. How these components, as well as utilities, are integrated into the ceiling without compromising the performance of the cleanroom is important. Designers should also take into account whether it is necessary to allow for possible future expansion of the cleanroom. The use of BIM (building information modeling) will help achieve a coordinated project and the eventual cost will depend on choices made in all these considerations.

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Book review
Basic Cleanroom Technology by William Whyte
Reviewed by John Neiger
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