Journal contents list

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Issue 31: July 2017

Innovations

Enzyme indicators (EIs) - an advanced replacement for biological indicators (BIs) in the qualification of vapour phase hydrogen peroxide bio-decontamination

Tim Coles

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Abstract

This paper introduces the newly available enzyme indicators which have the potential to speed up cycle development and cycle verification, in the hydrogen peroxide vapour bio-decontamination process. The recently published work of scientists at PHE Porton Down is reviewed, and the advantages of enzyme indicators over conventional biological indicators are put forward.

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An industry changing collaboration: Phillip Godden on the moment he discovered there was an alternative to Biological Indicators

Phillip Godden

Standards

Understanding ISO standards: ISO 14644-2:2015 cleanroom monitoring

Daniele Pandolfi

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Abstract

Following the article 'ISO 14644-1 revisions summary' in CACR30 (April 2017), this article continues the series of interpretations of particle counting standards with the evaluation of the recently released ISO 14644-2:2015 - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.

Major changes between the previous, 2000 version of ISO 14644-2 3 and the latest, second edition, dated December 12th 2015 are outlined. A specific approach to the best practices to be adopted for an efficient and compliant cleanroom monitoring process is discussed.

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Main features

Start-up of cleanrooms, initially and after a worst case event

Jim Polarine, Beth Kroeger

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Abstract

Environmental control of classified areas within a biopharmaceutical facility is maintained by systems controlling humidity, air temperature, air exchanges, filtration and pressure differentials and by practices such as room cleaning, limited access and facility flow. The failure of any of these systems has the potential to impact the clean state of a Classified Area. Many facilities have procedures in place to conduct the day-to-day operations but fail to have procedures in place to handle catastrophic or non-routine events. These disturbances should be defined as part of the Facility Cleaning Procedures in order to provide guidance to operators in the event they occur during off-shift or to provide a routine response to a non-routine event. The information in this article will provide an understanding of how these events may affect the cleanroom so measures may be taken to prevent issues leading to shutdown, costly discrepancy investigations, and potential lost product.

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Standardising pharmaceutical builds using BIM

Neil Pulman

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Abstract

For many years, the construction industry was said to be behind the times in adopting new technology. Whilst the automotive, energy and aerospace industries was left behind. This article explores the differences between BIM Levels, their benefits and what it means for the pharmaceutical sector.

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News

Particle Measuring Systems Celebrates 45th Anniversary

Contec's new Mop Saturation System simplifies the cleanroom mopping process

CHTS purchases Labcaire parts and servicing division from Cantel

Cleanzone 2017: A focus on digital monitoring solutions

Busy year continues for Clean Room Construction

Cherwell makes an Impact - with new continuous monitoring microbial air samplers

Must-attend summit Guangzhou International Cleanroom Technology Summit 2017

Events and Training Courses

Life-lines