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
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
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