Issue 13: January 2013

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Main features

Demand based control of laboratory air change rates
Gordon P Sharp

This article focuses on the results of research that represents what is believed to be
the largest study ever done of laboratory IEQ (Indoor Environmental Quality)
conditions covering over 1,500,000 hours of laboratory operation from laboratories
and vivariums that employ demand based control of air change rates. In total over 20
million sensor values were collected and analyzed including data on TVOCs (total
volatile organic compounds), particles of a size range of 0.3 to 2.5 microns, carbon
dioxide, and dewpoint (absolute humidity). This study of over 300 laboratory areas at
18 different facilities indicates that although laboratory events occur on a regular
periodic basis requiring an increase in air change rates to purge levels, on average,
air flow can be maintained at minimum levels of 2 to 4 ACH (air changes per hour) for
97 to 98% of the time.
Developments in isolators for biotech based and potent drug substances
Volker Sigwarth, Thomas Huber and Andre Boesinger
Some clear trends can be observed in the pharmaceutical industry. Firstly, more and
more drug substances are biotech based and therefore highly sensitive to
environmental influences. They also require aseptic production processes. Secondly,
drug substances in development and in production are becoming increasingly potent,
so that operator and environmental safety issues have gained higher priority.
Additionally there is an increasing pressure on the cost effectiveness and flexibility of
pharmaceutical production processes. Due to these facts, current production
processes and production equipment used represent a major challenge for Operational
Excellence initiatives.
This article focuses on the developments in isolator technology that are required to
deal with the characteristics of the new drug substances on one hand and the need for
effective and flexible production processes on the other.
Key words: H2O2 decontamination, isolator technology, fast transfer airlock, RTA
(rapid transfer airlock), Operational Excellence, process quality, residual H2O2
Enhanced filtration technology for reducing risk and saving energy
Hugo Hemel
HEPA filters and especially terminal HEPA filters need to guarantee that predefined air
quality requirements are consistently met for optimizing process efficiency and
assuring the highest product quality. In addition, with today's focus on the
environment, the contribution of air filtration towards meeting sustainability targets
has become much more important. AAF has recently launched NELIOR Filtration
Technology, a new air filtration solution that supports the realization of both
objectives. HEPA filters with NELIOR Filtration Technology provide important valueadded
benefits for applications that require classified environments, such as the
pharmaceutical and microelectronic industries. These benefits are demonstrated by a
newly developed Life Cycle Valuation programme. This article describes the
technology, the benefits and the new Life Cycle Valuation programme.

Periodic review of ISO 14644 Parts 1 and 2:
ISO TC 209 WG1 meeting in Zurich in September 2012
Gordon Farquharson
Periodic review of ISO 14644 Part 3:
ISO TC 209 WG3 meeting in Zurich in September 2012
Stephen Ward
Proposal for ISO 14644 Part 14:
Assessing the suitability of equipment and materials for cleanrooms
(ISO TC 209 WG11)
Richard Roberts

New Work Proposal to develop ISO 14698
(ISO TC 209 WG2)
Tony Harrison
British standard for improving energy efficiency in cleanrooms
Regulatory reflections
Application of Quality Risk Management to cleanroom design
Tim Sandle
Willis Whitfield
Bill Whyte
Book review
Review of 'The CDC Handbook - A Guide to Cleaning and Disinfecting Cleanrooms'
edited by Dr Tim Sandle
James H Filer

Hydrogen peroxide safety
Tim Coles
Vital vocabulary
T is for...
Contec, DOP Solutions, BioClean, Pharminox
Events and Training Courses

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