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Issue 43: 2020/Number Three

Main features

Real-time optimisation of vapour phase hydrogen peroxide bio-decontamination cycles using a new combined sensor

Tim Coles and Sanna Lehtinen

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Abstract

Bio-decontamination cycles using hydrogen peroxide vapour are currently controlled parametrically. A new hydrogen peroxide sensor introduced by Vaisala gives real-time values for both peroxide concentration and relative saturation (the point at which water and hydrogen peroxide vapour condense simultaneously). This offers the opportunity to control gassing cycles directly, and thus the potential to develop more precise cycles with faster turnaround, and reduced de-gassing effects.

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GMP-compliant environmental monitoring systems in stem cell and tissue laboratories: Seven frequently asked questions

Hasim Solmaz

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Abstract

New innovations in the field of medical technology bring with them special demands. Stem cell based treatments are undoubtedly amongst the most successful of the new treatments developed in recent years. The complex structure of stem cells demands specifically controlled environments for research, production, storage and delivery. As with traditional pharmaceutical products, many different items of laboratory equipment are involved as well as cleanrooms. All of these need monitoring in terms of regulatory compliance, efficiency and quality. In this article, the author shares with you the questions he often encounters in his native country Turkey – together with his answers.

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Cleanroom - known unknowns: 4. Airlocks

Andrew Watson

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Abstract

This article explores the known unknowns associated with airlocks and change-rooms. Design guidance, which is taken literally all too often, can lead to over-engineering and unnecessary complexity. This article looks at the fundamentals of airlock location and design and how systems of airlocks can help or hinder the operation of a cleanroom. We know that we need airlocks, but how many do we really need? The simple answer is “less than you might think”, but as usual, the reality is a lot more complex.

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Coronavirus pandemic shortages and the risks of using ineffective hand sanitisers in cleanrooms

Tim Sandle

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Abstract

Effective hand sanitisation using a alcohol-based sanitiser is an established part of cleanroom entry procedures. The coronavirus pandemic has led to supply shortages of hand sanitisers suitable for cleanroom use. Globally, regulators have relaxed some of the requirements for sanitiser manufacturers. This, coupled with subpar products entering the supply chain, could lead to inappropriate products reaching healthcare manufacturers. Included with products of concern are sanitisers containing methanol, as these are both microbiologically ineffective and highly toxic. The risks are considered together with some best practice advice for purchasers of cleanroom consumables.

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Letter

Test results and methodology in validation

Tim Coles

News

Events and Training courses

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