CoP Session: Production of Injectable Grade Water using Membrane Based Tech
10:45 AM – 11:15 AM | West Red Level, Suite 70
For years, the only universally accepted method for preparing injectable grade water (WFI) has been distillation. Recently, all of the major pharmacopeias have approved the use of alternative technologies for the preparation of WFI grade water. The preparation of WFI grade water using membrane-based technologies is more susceptible to complications, so ISPE assembled a group of experts from around the world to compile a best practices guide covering design considerations, operating and maintenance practices, and monitoring guidelines. This talk will cover those guidelines and considerations.
Speaker: Gary Zoccolante, President, Plymouth Rock Consulting
Gary V. Zoccolante is the Technical Director of Plymouth Rock Water Consultants. He was formerly Pharmaceutical Technical Director for Evoqua Water Technologies. Zoccolante has over 40 years of experience in the design, operation and trouble-shooting of pharmaceutical water systems. He has been involved in the development of equipment for pretreatment, reverse osmosis, deionization, ultrafiltration and distillation. Zoccolante, a member of ISPE since 1992 was a committee member of both the original and updated ISPE Baseline® Water and Steam Systems Guide. He has been part of the Guide Presentation Team on several occasions. He was involved in face-to-face meetings with FDA to help resolve many of the Guide principles. 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”. He was selected to deliver the first public presentation of the Guide. Zoccolante developed the four-day ISPE Pharmaceutical Water course and has presented the course to hundreds of pharmaceutical industry personnel including FDA personnel. 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. He has conducted several in-house courses on pharmaceutical water production and regulatory requirements for pharmaceutical companies. Zoccolante has authored and co-authored many papers on pharmaceutical water production and system operation and maintenance. He holds patents for pharmaceutical water processes. He has previous experience as manager of engineering and manager of application engineering. He holds a B.S. degree in Mechanical Engineering from Northeastern University.