Clean Air and Containment Review
The journal to enhance your knowledge of cleanroom, clean air and containment technology

Issue 15: July 2013
 
Main features
 
Real-time facility monitoring for quality and compliance
Tim Russell
Abstract
Pharmaceutical industry regulators are now encouraging quality rather than
compliance-based thinking. A facility monitoring system that includes realtime
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.
 
Guidance on personal protection when working with cytostatics and fabric
testing methods
Ian Samson
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 TyvekR and TychemR offer a superior level of
protection whilst exceeding requirements for these tests and offering
comfortable, flexible protection.
 
A guide to ductless fume hoods
X Q Lin
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.
 
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
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.
 
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

To access the full content of CACR in interactive pdf format, first enter the members section of the ICS website with your username and password.

To see the contents of all previous issues, please visit
www.cleanairandcontainment.com/journal-contents-list