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发表于 2023-9-23 11:38:18
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ISPE Issues Guidance for Ozone Water Sanitization Systems
ISPE对臭氧水消毒系统的问题指导
(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. (美国弗罗里达坦帕市,2012年8月14日)-ISPE今天宣布制药用水臭氧消毒系统的设计和使用的新的工业指导文件。The Guide provides important insight into ozone sanitization systems, and is the first industry Guidance Document to take a holistic view of these issues.该指导提出对臭氧消毒系统的重要观点。 It discusses specific system requirements, as well as associated advantages and disadvantages of using ozone as a water sanitization method. 它讨论了具体的系统要求，及相关的使用臭氧作为水消毒方法的优缺点。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.该指南将帮助企业更好地了解臭氧系统是什么，为什么它们可以作为更安全，更高效，更具成本效益的方式来净化制药用水，以及它们如何可以合并到新的和改造的设施。
“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. “对所有的只要生产操作来说，水消毒是一个重要的问题，臭氧系统是一个非常有效的替代化学和热的水消毒方法。However, the absence of non-biased industry guidance has prevented many companies from using this approach,” said Phillip Sumner, lead Guide author. 然而，缺乏非偏见的工艺指导阻碍了许多公司使用这个方法”首席指导作者Phillip Sumner 说。“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.”“通过非神秘化与臭氧系统相关的一些问题，ISPE正向业界和监管当局展示怎样臭氧可以合并为一个更安全，更具成本效益的消毒替代”
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. ISPE实践指南规范：《臭氧消毒的制药用水系统》提供臭氧消毒系统的概述，包括与其它消毒系统相比，公司决定使用臭氧系统时需考虑的监管因素和其他因素。The Guide discusses the effectiveness of ozone in microbial control. 指导中讨论臭氧对微生物控制的有效性。System design requirements for ozone generation, system operation and control and commissioning and qualification of ozone systems are also covered.臭氧产生，系统运行和控制的设计要求及臭氧系统的调试和合格认证也包括在内。
The ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems is available for purchase on the ISPE website.
ISPE实践指导规范：《制药用水的臭氧消毒系统》可以在ISPE网站上购买。
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