Clean Air and Containment Review





Editor: John Neiger
Publisher: Euromed Communications
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< Issue 40 | Issue 41 | Issue 42 >

Issue 41: 2020/Number One

Main features
Cleanrooms - known unknowns: 2. Cleanroom monitoring
Andrew Watson
Abstract →
Abstract

Following the previous discussion on source strength, this article explores the known unknowns associated with cleanroom monitoring. The shortcomings with current practices are described as well as ‘enhanced’ testing inside and outside the normal performance boundaries of your cleanroom. This will lead to a better understanding of how your cleanroom behaves, giving you the opportunity to improve your facility and better respond to challenges.

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Understanding critical measurement parameters in vaporized hydrogen peroxide bio-decontamination
Sanna Lehtinen
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Abstract

This article discusses the importance of the relationships between temperature and relative humidity in vaporized hydrogen peroxide applications and introduces a new parameter: relative saturation. Relative humidity (RH) is a critical parameter in H2O2 vapor applications whether with a dry or wet method of bio-decontamination. Relative humidity is, of course, relative to temperature, so that is the second important parameter. The higher the temperature, the more H2O2 ppm can be added to the air mixture before condensation occurs. However, the addition of hydrogen peroxide vapor to the air mixture also has a great impact on the point at which condensation occurs.

Relative saturation is a new measured parameter that indicates the point at which the combined water vapor and hydrogen peroxide vapor will start to condense. When the air mixture contains vaporized H2O2, relative humidity can never reach 100%, making it nearly impossible to know exactly when condensation will occur. The greater the temperature, the greater the allowable relative humidity. On the other hand, the higher the H2O2 concentration, the lower is maximum achievable RH. It is proposed that relative saturation is a critical parameter in bio-decontamination processes because it accurately represents the point at which condensation can be expected to occur.

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Assessing microbiological risks in cleanrooms following pharmaceutical facility shut-downs
Tim Sandle
Regulatory reflections
Latest draft of EU GMP Annex 1 signals changes for cleanroom management
Tim Sandle
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Abstract

EU GMP Annex 1 is currently going through a detailed revision process. In February 2020 a new draft was issued, with the final version expected later this year. The latest revision carries implications for cleanroom design and operations. The draft Annex introduces a new viable count qualification expectation; provides a Grade D particle count ‘at rest’ limit for the first time; and strengthens personnel controls. This article looks at these changes along with other expectations for cleanrooms and clean air devices.

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Decontaminating and decommissioning a biological containment facility
Tim Sandle
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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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Standards
An update on 14644 Cleanroom Standards: Parts 8, 9, 10 and 16
Dick Gibbons
An update on 14644 cleanroom standards: Parts 14, 15 and PWI 23294
Richard Roberts
Discussion
"Honey I shrunk the cleanroom"
James Akers
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Abstract

This article comprises comments from James Akers received directly by Tim Coles as four e-mails in response to the publication of his article “Standards for pharmaceutical isolators: an overview” in CACR40. The comments are reproduced here in the form of an informal article by kind permission of James Akers and Tim Coles. The proposal for specific isolator standards is supported, since isolators are very different from cleanrooms. There is concern about using log 6 reduction as the target for bio-decontamination, and the value of continuous environmental monitoring is questioned. It is suggested that an isolator standard might be developed with international co-operation.

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Is log 6 overkill for an isolator?
Rick Nieskes
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Abstract

This article comprises comments from Rick Nieskes received directly by Tim Coles in response to the publication of his article “Standards for pharmaceutical isolators: an overview” in CACR40. The comments are reproduced here in the form of an informal article by kind permission of Rick Nieskes and Tim Coles. Concern is expressed over appropriate levels of environmental monitoring and particle counting in isolators. There is some discussion on leak rates, and there is a suggestion that an intermediate Class 3.5 leak rate is required. Doubts are also expressed over the legitimacy of log 6 reduction as the target for bio-decontamination.

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