Previous Issues

Newsletter Archive

by Neda Zahid, Abbott Laboratories and Andrea Massa, Burkert Fluid Control Systems, photos by Brian Hagopian, Clear Water Consulting, Inc.

With the highly anticipated release of the ISPE Baseline Guide for Water and Steam Systems (Second Edition), The Pharmaceutical Water Conference was held at Biogen Idec in Cambridge on Thursday, March 15. The educational program is the result of a unique collaboration between the Boston Area Chapter, ISPE International and the ISPE Critical Utilities Community of Practice (COP).

Prominent subject matter experts attracted scores of attendees to both the introductory & advanced sessions.

After a vibrant afternoon networking session, Boston Area Chapter President Brian Hagopian delivered opening remarks which were followed by the event's first speaker. The comprehensive half-day seminar included both introductory and advanced tracks: an assortment of topics presented by authors of the guide itself. Going beyond the information presented in the guide, the distinguished group of speakers gave attendees a wealth of knowledge and an exclusive "behind the scenes" perspective.

Introduced as the "Smartest Microbiologist in the US," T.C. Soli started off the event with a riveting discussion of microbiology and its often misunderstood impact on pharmaceutical applications.  T.C. was a smooth and engaging speaker as he imparted the reasons for adding a new chapter for microbiological considerations and provided exceptionally helpful CliffsNotes about common misconceptions, design considerations, and sanitization concepts.

Daryl L. Roll was the second speaker and gave an engaging discussion on rouge and techniques for monitoring, measuring, and remediation. After providing a topic overview, he explained various removal and control methods. Daryl illustrated how a science-based approach can be used when developing a derouging maintenance program. He outlined how technology for system monitoring and data collection can be used to set engineering action limits when developing such a program.

A buffet dinner provided an opportunity for networking between the afternoon & evening sessions.

Following these afternoon presentations, the audience had the pleasure of continuing conversations and follow up questions. A program "intermission" with dinner and networking paved the way for the evening's dual-track program.

In the advanced track, with more than 30 years of experience, Joe Manfredi led a dynamic discussion on the proper design and installation of sampling and instrumentation ports. He immediately captivated the audience by illustrating case studies of common obstacles and moreover, shared his expertise on design solutions and best practices. In short, Joe's presentation was highly enlightening as he emphasized the importance of considering sampling in design and project planning.

Next, Cameron Sipe presented a lively discussion on the new Baseline Guide's revised chapter on pharmaceutical steam. He outlined the purpose for revising this portion of the guide and was exceedingly informative as he described significant revisions. Cameron then explained system planning by illustrating types of steam and applications for use.

Last but not least in the advanced track, Phil Sumner gave a two-part presentation.  He began by describing the new chapter on laboratory water, sharing the various perspectives necessary for designing a laboratory water system. Next, he shared glimpses into the soon to be released ISPE Good Practice Guide: Ozone, with over 30 specialists contributing to its creation.  Phil gave a tremendously informative talk, providing the history of ozone sanitization and the tools for understanding a complete ozone sanitization system.

Andrew Collentro and Gary Zoccolante were natural teachers in the introductory track. Andrew Collentro, a dynamic and passionate presenter, explained the importance of water as the universal solvent and most widely used ingredient.  He clearly and concisely described the types of pharmaceutical water, the governing regulations, and the various pre-treatment options; in parallel, he referenced the knowledge offered within the Baseline Guide and illustrated this with useful examples from his own experience.

To wrap up the evening in the introductory track, Gary Zaccolante delivered an "all-inclusive" presentation that took the audience into various final treatment processes and, additionally, described general considerations for both storage and distribution. He discussed theories behind these important concepts and used detailed illustrations and process diagrams to aid understanding. The audience had many excellent questions for Gary during his presentation, indicating their high level of engagement throughout.

In summary, this unique educational forum offered a top-notch cast of experts and tremendous presentations filled with complete and comprehensive information from beginning to end. In addition to the content presented, attendees had a unique opportunity to ply the presenters with dozens of questions, receiving additional information geared to their specific concerns. Following the formal program, a lively networking social was held at Mead where many of the discussions continued.

The Chapter would like to thank all of our speakers for their wonderful presentations and everyone who helped make this event a great success!