WHEN:
Thursday, January 16th, 2025
5:00 PM - 8:30 PM EST
WHERE:
Alnylam Pharmaceuticals
20 Commerce Way
Norton, MA 02766
PROGRAM DETAILS:
Changing Paradigms in Pharmaceutical Water
While distillation remains the gold standard, most regulatory agencies now accept membrane-based water purification systems for WFI quality water production. With sustainability goals in mind, many companies are exploring ambient temperature membrane-based WFI systems, which often leads to considering ozone as a sanitizer instead of heat. However, there are several considerations, such as what needs to be sampled where and how to validate equipment functionality. Attend this session to meet, network with, and learn from industry experts, and tour Alnylam’s Norton facility, which features both distillation and membrane-based WFI systems. This event will sell out quickly!
AGENDA: (session order subject to change)
5:00 PM - Arrival, Networking, and Plant Tours*
6:30 PM - Membrane Based WFI Systems presented by Gary Zoccolante and Andrew Collentro
7:00 PM - Ozone Use in Pharma presented by Joe Manfredi and Brian Hagopian
7:30 PM - Alnylam's justification and thought process for using distillation and membrane based WFI, and their plans to add ozonated storage presented by Bill Frederick
8:00 PM - Process vs Quality Control Sampling, Instrumentation, Point of Use vs. Loop Outlet Valve, inline vs. grab sampling variations for TOC and conductivity and thoughts on validating instrumentation presented by Brian Pochini and Anthony Bevilacqua
8:30 PM - Presentations conclude
*Tours are member-only, and limited to 60 people. ISPE Boston will reach out to registered members to offer time slots*
SPEAKERS:
REGISTRATION FEES:
Registration by EOD Wednesday, January 8, 2025
Members (Early Bird): $50
Non-Members (Early Bird): $95
Emerging Leaders Members (Early Bird): $20
Student Members: FREE
Registration Starting Thursday, January 9, 2025
Members: $60
Non-Members: $115
Emerging Leaders Members: $30
Student Members: $10
**PLEASE NOTE: CANCELLATIONS RECEIVED ON/AFTER JANUARY 9 ARE SUBJECT TO BILLING**