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Issue 49: 2023/Number One

Main features

Airborne particle counting with an LSAPC

W. Whyte

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Abstract

This article is the fourth of a short series of extracts from Bill Whyte's new book Cleanroom Testing and Monitoring. Chapter 11, Airborne particle counting with an LSAPC, 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.

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Particle deposition rate application ISO standard to control contamination by macro- and visible particles

Koos Agricola

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Abstract

Starting in 1999, ISO TC209 has published a series of standards on cleanrooms and associated controlled environments. Since the publication of the first standard, 16 further standards have been developed and published. With respect to particles the focus has been on airborne particles up to 5 micrometers (μm). In many applications larger particles, which have been termed macroparticles, and even visible particles, need to be controlled. ISO 14644-17 'Particle deposition rate applications' provides guidance on the control of these particles. This paper gives background information and a personal view on the application of this recent standard.

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Environmental Monitoring in Advanced Therapeutic Medicinal Products (ATMP) facilities

Mark Hallworth

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Abstract

With the increase of Advanced Therapeutic Medicinal Products (ATMPs), therapy development, and available marketed products, the modern manufacturing process must meet relevant regulatory requirements. ATMPs are pharmaceutical products or drugs; ATMPs require the cellular product to be modified, not simply transplanted. Where more complex cell therapy manufacturing is required or cells are used in the treatment of a different organ, the processes must adhere to different regulatory agency approvals to ensure they are manufactured in facilities that pose low risk (or acceptably low risk) to the patient. The FDA and EMA are responsible for ensuring the safety, efficacy, and compliance with Good Manufacturing Practices for manufacture.

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Control of viruses within cleanrooms: A review of disinfectant agents

Tim Sandle

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This paper identifies the risks of contamination by viruses in the manufacture of biopharmaceutical products in cleanrooms. Different types of viruses are described with non-enclosed viruses being more resistant to disinfectants. Care should be taken as many common disinfectants are only suitable for bacterial or fungal contamination. A table gives guidance on the selection of appropriate disinfectant types to deal with viral contamination

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Where did it all go so wrong? An account of the turbulent history of Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination

Tim Coles, Rick Nieskes and James Agalloco

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Abstract

This paper considers the current industry status of the vapour phase hydrogen peroxide (VPHP) bio-decontamination process, and its supposed fragility in relation to sterilisation. Some brief historical notes are followed by consideration of appropriate challenges. It is argued that with good understanding, monitoring, and controlling of the principal VPHP cycle parameters, together with certain changes to the BIs themselves, then bio-decontamination by VPHP can be considered to be a sterilisation process.

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Standards

ISO Technical Report* 14644-21 is set to join the ISO 14644 family

John Hargreaves and Andrew Watson

Book review

Cleanroom Technology by William Whyte

Reviewed by John Neiger

BSI invites you to Download your Little Book of Net Zero for free

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