Webinar: Membrane-Based Water for Injection

WFI regulatory requirements and membrane-based system design

Distillation has been the most common technology used to produce Water for Injection (WFI) due to historical regulatory requirements. However, changes in the European Pharmacopeia no longer require the use of distillation to produce WFI. In this webcast, learn about the impact of this regulatory change on water system design and how reverse osmosis and ultrafiltration can be used to produce WFI with significant lifecycle cost advantages.

Key learning objectives:

  • WFI regulatory requirements
  • How to design a WFI system with non-distillation technologies
  • How to convert an existing system to WFI production
  • What is required to qualify a membrane-based WFI production system

water for injection

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Speakers

 

Gary Zoccolante
Technical Director, Plymouth Rock Water Consultants

Gary Zoccolante has more than 45 years of experience in the design, operation, and trouble-shooting of pharmaceutical water systems. He holds a bachelor’s degree in mechanical engineering from Northeastern University and was pharmaceutical technical director at Evoqua Water Technologies for over 35 years. He has also been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation.

Zoccolante is a member of the ISPE Critical Utilities Community of Practice Steering Committee. He has worked on the development of the ISPE Good Practice Guide—Commissioning and Qualification of Pharmaceutical Water and Steam Systems Editions 1 and 2.

Gary Zoccolante is a frequent lecturer for many pharmaceutical groups and has chaired many courses. He has presented for ISPE, Interphex, American Institute of Chemical Engineers, American Society of Mechanical Engineers, Institute for International Research, Center for Professional Advancement, PDA, Pharmtec, Barnett International and many others. Zoccolante has authored and co-authored many papers on pharmaceutical water production and system operation and maintenance. He also holds several patents for pharmaceutical water processes.

Rich Jarrett
Director of Pharmaceutical Marketing, Evoqua Water Technologies

Rich Jarrett is Evoqua’s pharmaceutical marketing director, leading efforts around water treatment solutions and product requirements for the pharmaceutical industry. He has more than 14 years of experience working with the pharmaceutical industry in developing products and services for improved quality, reduced cycle time, enhanced manufacturing and regulatory compliance.

Jarrett is a member of ISPE and the Critical Utilities Community of Practice.