ISPE Issues Guidance for Ozone Water Sanitization Systems

Published: Aug 14, 2012

(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; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit for additional Society news and information.

For more information contact:

Danielle Hould

ISPE Communications Manager

Tel: +1-813-960-2105, ext. 277


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