Clean Air and Containment Review





Editor: John Neiger
Publisher: Euromed Communications
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Journal contents list

< Issue 39 | Issue 40 | Issue 41 >

Issue 40: 2019/Number four

Standards
Standards for pharmaceutical isolators: an overview
Tim Coles
Abstract →
Abstract

Pharmaceutical isolators have wide application in critical processes such as aseptic filling and genetic engineering, and yet they are not covered by any specific UK, or international standard. At present, users have to rely on standards essentially written around cleanrooms, which are a very different contamination control system. There is also one standard which is a sub-section of an aseptic processing standard. This paper highlights areas where these existing standards are perhaps deficient.

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The sense and otherwise of ISO 16890: Air filters for general ventilation
Alexander Fedotov and Oleg Provolovich
Abstract →
Abstract

At the end of 2016, the ISO 16890 series of standards replaced EN 779 standard on filters for general ventilation. EN 779 is well-known, well accepted and widely used for the specification of pre-filters for cleanrooms and other controlled environments. It was declared that ISO 16890 gives a better picture of indoor air quality than EN 779 in terms of particle contamination.

But is this really so?

There are two areas of application for air filters for general ventilation that differ from each other in principle:

1. to protect humans.

2. to help achieve the necessary air cleanliness levels by serving as pre-filters in certain technologies and processes.

The first purpose has been known for centuries but the second came from industrial progress and the appearance of cleanrooms and other controlled environments. This article discusses this and other issues concerning ISO 16890.

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EN 1822 and EN ISO 29463
Chris Hews
Features
Cleanrooms - known unknowns: 1. Source strength
Andrew Watson
Abstract →
Abstract

This article is the first of a series that identifies gaps that still exist between practice and meaningful verification in the design, operation and testing of cleanrooms. The topic for this article is source strength and the article assesses the validity of published source strength data as well as source strength data derived from body box testing for the purpose of calculating airflow rates in cleanrooms.

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Decontaminating and decommissioning a biological containment facility
John Yuill
Abstract →
Abstract

This article is aimed at giving a greater understanding of the requirements of decontaminating and decommissioning equipment and facilities that have been contaminated with products that could adversely affect the health and wellbeing of the decontamination operatives involved in its safe removal. The article also discusses the effects on the environment and other staff along the safe disposal routes of the resultant wastes produced.

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Letter
Observing airflows in cleanrooms
Bill Whyte
Life-lines
News
Events and Training courses