Clean Air and Containment Review

Editor: John Neiger
Publisher: Euromed Communications

Journal contents list

< Issue 41 | Issue 42 | Issue 43 >

Issue 42: 2020/Number Two

Main features
The science of airborne viruses: how particles move and what you can do to protect yourself
Luke Mintz
Impact of novel coronavirus SARS-CoV-2 in cleanroom operations
Tim Sandle
Abstract →

The novel coronavirus SARS-CoV-2 is causing problems globally. This includes cleanroom users. The virus can be passed in the air and it survives on surfaces for prolonged periods of time. While existing protective measures should minimise air risks (such as HEPA filters, air change rates, wearing masks and gloves) the surface risks, due to prolonged survival times, require careful selection of appropriate agents (primarily either alcoholic products at 61 to 71% concentration or hydrogen peroxide at 0.5% or higher).

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Cleanroom - known unknowns: 3. Positive pressure versus negative pressure
Andrew Watson
Abstract →

This article continues the exploration of known unknowns in cleanroom and containment design. This time we examine the application of positive and negative pressure regimes to an installation according to the materials that are processed within it. Ordinarily, a black and white approach is adopted - if it’s toxic, infectious or genetically modified, then it must be processed in a room that is negatively pressurised in relation to the surrounding environment. Otherwise, positive pressure is fine. However, when you look at the mechanisms whereby contamination is distributed, there are compelling reasons for always staying positive.

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An innovative Active Air Sampler for continuous viable air monitoring with minimal plate changes
John Cobb
Abstract →

The EU Manufacture of Sterile Medicinal Products Annex 1 version 12 Revision is, as of 20 February 2020, undergoing a targeted three month consultation process. The proposed changes include the requirement for “continuous viable air monitoring in the Grade A zone to be undertaken for the full duration of critical processing, including equipment (aseptic set-up) assembly and filling operations.”

In addition to this it is also a requirement to investigate any microbial counts and for any organisms isolated to be investigated and identified down to species level. Furthermore their potential impact on product quality for each batch affected and the overall state of control during sterile manufacturing should be investigated, as part of a documented system.

We consider now a new design of active air sampler that is capable of a very high, industry leading, Biological Efficiency, which can be used for an interval sample of 1 cubic metre of air. More importantly this new air sampler can be employed for up to 4 hours on a single plate of TSA (Trypticase Soy Agar) irradiated agar, at critically assessed risk locations in Grade A environments, with minimum human interventions. This method of active air sampling can supplement or replace settle plates for more accurate microbiological sampling over an entire production run, providing a greater understanding of the level of microbiological control in the Grade A zone.

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An update on 14644 cleanroom standards: Parts 3 and 4
Stephen Ward
A new European standard for Biocontamination Control - EN 17141 will replace EN ISO 14698 Parts 1 and 2:2003
Conor Murray and Roland Durner
Abstract →

Cleanrooms and clean controlled environments are classified based on airborne particle concentrations. Depending on the purpose, further characteristics or contaminants can be considered. Biocontamination plays an important role in microbiological control in many applications in a cleanroom or clean controlled environment. The existing standard for Biocontamination control in cleanrooms and associated controlled environments, ISO 14698 Parts 1 and 2 from 2003, has had limited application. The European Committee for Standardization (CEN), through an initiative of Technical Committee (TC) CEN/TC 243/WG5 (Working Group 5), has been working on revising and updating the ISO 14698 standard since 2016. The new EN 17141 standard, which is based on this work, will be published in the summer of 2020. Recently countries voted unanimously to withdraw the ISO 14698 Parts 1 and 2 standards as part of the ISO systematic review process. CEN/ TC 243 is now putting forward EN 17141 for inclusion in the ISO 14644 family of standards in order to harmonise the approach to contamination control o microorganisms in air and on surfaces, with that of particles and other contaminants in air and on surfaces.

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Bio-decontamination using vaporised hydrogen peroxide: comments on a recent article
Tim Coles
Events and Training courses