Ye Xun
Topic：Introduction of the Regulations of EU Non-distillation Methods
Presentation Summary：In the United States and Europe, a series of regulations, guidelines and regulatory measures for the production of WFI using non-distillation methods have been established, while currently in China, only the distillation methods can be used. This presentation introduces the regulations of EU and ISPE on the production of WFI using nondistillation methods. It also analyzes the existing problems in the production of purified water by membrane methods in our country and the approach with non-distillation methods.
- Time：2021-10-21 11:35~12:20
- The expected time：45 minutes
- Meeting room：Aseptic Processing Sub-forum
Ye Xun has undergraduate college degree, and is the professor level senior engineer. Member of Expert Committee, China Pharmaceutical Association of Plant Engineering. External consultant of Sunwell company in Canada. From 2008 to 2020, deputy manager of Technical Service Department of freseniuskabi SSPC Pharmaceutical Co., Ltd. He is the project manager of SVP expansion, microorganism room transformation, sub packaging production line project, administrative building and new R&D center project, soft bag nutrition oral liquid project, etc. Over the past 20 years, it has been devoted to the research on the production and transportation of pharmaceutical water, Papers such as "Application of whole membrane water treatment process in purified water production" and "Discussion on Design of medical purified water pipeline system" were published. He has 3 national invention patents and 10 utility model patents.
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