Journal contents list

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Issue 15: July 2013

Main features

Real-time facility monitoring for quality and compliance

Tim Russell

Abstract →

Abstract

Pharmaceutical industry regulators are now encouraging quality rather than compliance-based thinking. A facility monitoring system that includes real-time viable particle monitoring as well as real-time total particle monitoring is an extremely useful tool for achieving the necessary quality. A true example is given of how real-time viable particle counting can give different and more reliable information than real-time total particle counting.

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Guidance on personal protection when working with cytostatics and fabric testing methods

Ian Samson

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Abstract

This article, which was originally written by DuPont as an Educational Guide describes the attributes of fabrics for disposable coveralls used as personal protection equipment (PPE) for staff working with cytostatics. Fabrics and garments have to be tested for barrier efficiency, particle shedding, particle emission and particle intrusion, and the relevant tests are described. Protective clothing made from Tyvek® and Tychem® offer a superior level of protection whilst exceeding requirements for these tests and offering comfortable, flexible protection.

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A guide to ductless fume hoods

X Q Lin

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Abstract

This article is a basic description of the design, advantages, applications, testing and safe operation of ductless fume hoods. Ductless fume hoods utilise activated carbon filters for the removal of fumes and the manufacture, physical properties and applications of these filters are described in some detail.

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Activated carbon filters and cytotoxic drug vapours:

Report on carbon filter project at The University of Bath

John Neiger

Innovations

Real time measurement of particle deposition

Anton Duisterwinkel

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Abstract

Much attention in cleanrooms is currently given to airborne particles. But product quality is not harmed by small particles in air that do not deposit, but by larger particles that do fall onto the product. Particle deposition occurs even in the best cleanrooms where people are working or machines are running. This is amply demonstrated experimentally, with cumbersome, slow and expensive methods. The award-winning invention of Technology of Sense, The Advanced Particle deposition MONitoring system (APMON), shown in Figure 1, is affordable, stand-alone and the first and only system that is able to measures the deposition of =25 µm particles in real-time. Every ten minutes the APMON informs the user of the local situation. It can be used as an alarm, for training staff, finding root causes of particle deposition and even for setting standards on particle deposition in cleanrooms.

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Standards

Updates on the ISO 14644 series of standards and on filter standards

John Neiger

Regulatory reflections

Just published: WHO guidance on quality risk management

Hans H Schicht

Conference report

4th Annual BSI Cleanrooms Conference: Cleanroom Energy - How to improve energy efficiency in cleanrooms, IMechE, London, June 14 2013

John Neiger

Book review

Review of 'Cleanroom Management in Pharmaceuticals and Healthcare' edited by Tim Sandle and Madhu Raju Saghee

James H Filer

News

Contec, Cavendish, Pharminox (1), Validair, DOP Solutions, CRC, Pharminox (2)

Vital vocabulary

V is for...

Events and training courses