Clean Air and Containment Review

Editor: John Neiger
Publisher: Euromed Communications

Journal contents list

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Issue 44: 2020/Number Four

Main features
Reducing cleanroom HVAC energy use by following a scientific approach
Nigel Lenegan
Abstract →

In this article, the author draws on his experience to describe how most organisations in the pharmaceutical sector have already put into effect the simpler, less expensive measures for achieving energy savings, and argues that the time has come to look more carefully at HVAC and, particularly, fan power. For example, US guidance on air change rates has not been revised since 2004. Since then, many aspects of cleanroom operations have improved, contamination risks have been reduced and recently there has been recognition that the amount of filtered air supplied to a cleanroom should be based on a scientific assessment of the potential sources of contamination and their estimated strength and not on a traditionally prescribed air change rate value. This approach has been shown to achieve energy savings of up to 30%.

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Containment leakage testing
Joshua Magor
Abstract →

This article discusses why containment facilities require low leakage construction. It is based on experience with the Australian Centre for Disease Preparedness (ACDP) facility and the acceptance criteria set for its testing. Two formulae for calculating the leakage coefficient Beta are compared; one takes into account the room volume while the other only considers the measured air leakage rate regardless of room volume. To aid in the understanding of the effect of different leak rates, a formula is derived to calculate the theoretical concentration of fumigant in a room with respect to time. This formula is used to compare common leak rates discussed in literature, the current leak rates seen at the ACDP and the effect of varying room size. Finally, there is some reflection on the uniqueness of different facilities posing the question - should there be a “one size fits all” approach to setting the allowable leak rates or should these be assessed based on the criticality of the room or facility?

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Face masks: Lessons from COVID-19 research
Tim Sandle
Abstract →

The 2020 novel coronavirus pandemic has led to a wider interest in the classification, performance and testing of face masks. This article assesses the international standards for face masks and proceeds to examine some recent COVID-19 related examinations of face masks. Some of the outcomes of these studies are pertinent to general cleanroom use and help to inform cleanroom users about the importance of mask selection, mask donning, fitting, expiry time, and post-use handling.

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Energy efficiency in cleanrooms and clean air devices: ISO 14644-16
Richard Gibbons, Convenor, ISO/TC 209 WG13
Abstract →

The ISO 14644 family of cleanroom standards has been at the centre of International cleanroom standards development for many years and covers most facets of cleanroom activity and cleanroom types from large ballroom cleanrooms to isolators and clean tunnels. Historically the series started with information on the testing and measurement of airborne particle concentrations and a classification system for allowable particle concentrations within cleanrooms. Guidance on basic design and practice quickly followed and led to the series of ISO cleanroom standards that is now accepted worldwide. The series is under constant review and is still expanding.

Recent documents that have been released concern the quantification of airborne and surface chemical concentrations, nanoparticles and the selection and testing of equipment used within these rooms. However, apart from some misleading information in the original Part 4 design document, questions concerning the energy demands from air purification processing have been overlooked. Nationally, institutions such as the BSI in UK, DIN- VDI in Germany and IEST in the USA have produced limited information on the topic, but Part 16 is the first standard to be internationally agreed. This article explains the key features of the new standard which was released in May 2019.

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Book Review
Advances in Practical Safety Ventilation by Bengt Ljungqvist and Berit Reinmuller
Reviewed by Tim Sandle
Lawrence Whittard: Founder of Cherwell Laboratories
Events and Training courses