Ozone has been utilized for more than 100 years to sanitize municipal drinking water supplies, ensuring its potability and reducing organic content. It has also been used for more than 40 years in pharmaceutical water storage and distribution systems. In 2012, ISPE published the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems.
Since then, the use of ozone in the pharmaceutical industry has significantly increased as the knowledge base regarding its use has expanded. The second edition of this ISPE Good Practice Guide provides comprehensive guidance on designing and operating pharmaceutical water storage and distribution systems that use ozone for sanitization, outlining key principles for implementing an effective sanitization approach.
The microbial content of water is important to product manufacturing, cleaning, and some laboratory activities in pharmaceutical and biopharmaceutical facilities. Systems that produce and distribute these waters must generally maintain continuous control to minimize microbial content, biofilm buildup, and endotoxins. Controlling microbial presence and proliferation in pharmaceutical water storage and distribution systems is typically achieved through heat, chemical sanitants, or ozone. This Guide focuses on the use of ozone as a sanitizing agent.
“Ozone initially faced resistance in the pharmaceutical industry because many did not know how to properly apply it,” said Brian M. Hagopian, CPIP, President, Clear Water Consulting Inc. Hagopian is a chemist who served as a co-lead of the Guide. “During its initial use in the industry, companies may have introduced too much ozone and did not realize that being such an aggressive chemical, ozone not only eliminated bacteria (which is its intended purpose), but it also attacked elastomers, leading to leaks.”
“Now the understanding of ozone has improved,” he said. “Coupled with the widespread regulatory acceptance of membrane-based technologies to produce water for injection (WFI) grade water, the use of ozone as a sanitant is expected to increase across the industry in the future. During the industry review of this Guide, the authoring team received valuable comments and feedback, which was incorporated to make this Guide more comprehensive, well-rounded, and inclusive.”
“The Guide discusses ozone-specific requirements, including associated advantages and disadvantages,” said Philip E. Sumner, Jr., PE, Senior Manager, Pfizer Global Engineering. Sumner served as a co-author of the Guide. “It also guides the reader through system design, operation, and control. As with any system design, it is the responsibility of the owner and the design team to evaluate ozone’s applicability, taking into consideration the design guidance provided in this Guide. Ozone sanitization has many benefits, including fewer and shorter interruptions to manufacturing due to water system sanitization, cost savings due to less energy use, and reduction in carbon footprint.”
“An additional advantage of ozone as a sanitization method is its ability to reduce biofilm, which heat does not,” said Rod Freeman, Associate Director, Quality Engineering, Kite Pharma, Inc. Freeman served as a co-lead on the development of the Guide.“It can also provide a safer environment for workers by avoiding exposure to scalding pipes or clamps, and it offers an ambient temperature sanitization alternative that eliminates the need to heat the water up and cool it back down. The expert team of authors who worked on the Guide shared their knowledge and experience to help develop best practices that expand the use of ozone sanitization based on knowledge of its principles and benefits.”
Learn More
