The Educational Session will cover
1.Short background of the development of cold WFI production in US and Europe.
2.Detailing the present situation on cold WFI production systems
3.Reverse osmosis and biofilms
4.Control strategies for biofilms
5.Main elements to be considered in the design
6. Approach for system qualification
7.Sampling regime for qualification
8.Testing during initial qualification and routine operation sampling
9.Preventative maintenance on RO systems used for the production of WFI
About the Presenter
Mr. Shlomo Sackstein is Chief Executive Officer at Biopuremax and the Biopuremax patent holder, with a BSc in Mechanical Engineering from Technion - Israel Institute of Technology and an MBA in Business Administration from Tel Aviv University. Biopuremax is a Turn Key contract supplier of Biopharma water systems in which Biopuremax, designs and builds production, storage and distribution systems for PW,
HPW and WFI. Shlomo has been designing, installing, validating and operating high purity water systems for 20 years in the Biopharma industry all over the world, including: North America, China, India, Europe and Middle East. He has expertise in pretreatment, production and storage & distribution systems for
PW/HPW/WFI, USP/EP. The author of many publications in internationally recognized peer reviewed publications including: Pharmaceutical Engineering, Pharmind, Technopharm, PDA Letter, Cleanroom Technology Magazine and more. Took a lead part in writing the latest update in the ISPE Baseline, Volume 4: Water
and Steam. Shlomo Sackstein is a long-standing member of ISPE and previously a member of the ISPE Sub Committee for Critical Utilities. In addition Shlomo is an active member of the executive board of the Israel PDA chapter. Presently the chairman of the ISO standards committee TC282 / WG 3 Purified water
(PW) and water for injection (WFI) pretreatment and production systems
20 июн 2020
