Pharmaceutical Water Takes Center Stage in January

Pharmaceutical water will be the focus for the Boston Chapter’s first educational program of the 2025 year, being held the evening of January 16th at Alnylam’s Norton manufacturing facility. Pharmaceutical water is both a precious and widely used critical utility serving a multitude of purposes including acting as an ingredient, carrier, diluent, cleaning agent, and much more. Attend this program to learn about the current state of the art and the changes that may influence water system decisions for the next decade.

Over the past several years, technological advances coupled with regulatory acceptance have the potential to completely reshape how pharmaceutical water is generated, stored, distributed, and disinfected. With the nearly universal acceptance of membrane-based systems to produce water for injection (WFI) grade water, companies now have more options available to them for producing this precious utility. But, there are also challenges and risks that must be understood to successfully implement these technologies.

Attend this program to learn from an A-list of subject matter experts who will share their over 250 years of collective experience at this one-of-a-kind event.

The program will begin with a historical discussion of both distillation and membrane based WFI technologies with current regulatory positions leading to the potential for expanding the use of ambient temperature WFI systems across the industry. The program will report on current trends and experiences with the use of membrane based WFI systems around the world. Hand in hand with an expected increase in ambient temperature WFI systems is potential for more widespread use of ozone for sanitization and disinfection purposes. Ozone initially received a black eye in the industry because it was both misunderstood and misapplied, but our knowledge base has significantly increased in recent years and ozone use is gaining momentum. The issue of ozone as an added substance will be covered along with recommendations to address this issue. This will be followed by a presentation by our host company that will bring attendees through Alnylam’s decision making process surrounding their initial installation of a distillation based WFI system when their Norton facility was first constructed and the technical and economic justification used as they chose to install a membrane based WFI system for their current expansion efforts. The session will conclude with an open discussion on several topics of interest including advances in instrumentation and monitoring, process vs. quality control sampling issues and what a “point of use” really is.

Before the evening program begins, Alnylam has agreed to allow a limited number of attendees tour their central utility area for a hands on look at the WFI equipment installed in their Norton facility. This is exclusive to ISPE Members only.

Presentations and discussions are sure to be lively at this must-attend event. If you know any of the speakers, you know this will be a special event. If you don’t, you’re in for a real treat! Register now before the program sells out.

Learn More and Register HERE