ISPE Issues Guidance for Ozone Water Sanitization Systems
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FOR IMMEDIATE RELEASE
Contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
Fax: +1 813.264.2816
dhould@ispe.org
www.ISPE.org
ISPE Issues Guidance for Ozone Water Sanitization
Systems
(TAMPA, FLORIDA, USA, 14 August 2012) – ISPE announced today that it has
issued new industry guidance on the design and use of ozone systems for pharmaceutical water
sanitization. The Guide provides important insight into ozone sanitization systems, and is the first
industry Guidance Document to take a holistic view of these issues. It discusses specific system
requirements, as well as associated advantages and disadvantages of using ozone as a water sanitization
method. The Guide will help companies better understand what ozone systems are, why they can be a safer, more
efficient and more cost-effective way to sanitize pharmaceutical water, and how they can be incorporated into
both new and retrofitted facilities.
“Water sanitization is a vital issue for all pharmaceutical manufacturing operations, and ozone systems
are an extremely effective alternative to chemical and heat-based water sanitization methods. However, the
absence of non-biased industry guidance has prevented many companies from using this approach,” said Phillip
Sumner, lead Guide author. “By demystifying some of the issues associated with ozone systems, ISPE is showing
industry and regulatory authorities how ozone may be incorporated as a safer, more cost-effective
sanitization alternative.”
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems provides an
overview of ozone sanitization systems, including regulatory considerations and other factors companies
should take into account when deciding to use ozone vs. other sanitization approaches. The Guide discusses
the effectiveness of ozone in microbial control. System design requirements for ozone generation, system
operation and control and commissioning and qualification of ozone systems are also covered.
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems is available for
purchase on the ISPE website.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of
22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality,
cost-effective GMP solutions. ISPE will soon be recognized globally as the leading technical organization for
professionals engaged in producing quality medicines and pharmaceutical devices across the entire product
lifecycle. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its
worldwide headquarters in Tampa, Florida, USA, as well as offices in Brussels, Belgium, Singapore and
Shanghai, China. Visit www.ISPE.org for additional Society news
and information.
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