Conference track explores USP 797


By Angela Godwin

An important new program track entitled Hospital pharmacy compounding-Compliance challenges and USP 797 has been added to this year’s CleanRooms Contamination Control Technology (CCT) conference program being presented this March in Boston. The track will provide attendees with the authoritative and real-world advice and information they will need to demonstrate competence and compliance as outlined in Chapter 797: Pharmaceutical Compounding-Sterile Preparations. Introduced in 2004 by the United States Pharmacopeia, this standard for compounding sterile products presents guidance and examples for compounding, but does not provide specific, comprehensive information describing how to meet those standards. This task has been left to pharmacy professionals.

Throughout the course of the two-day conference track, several key topics will be explored, including sterility assurance in controlled environments, documentation for regulatory compliance, and microbiological testing and monitoring.

According to Hank Rahe, director of technology for Containment Technologies Group and co-chair of the USP 797 conference track, the “real strength of this track lies in the expertise of the speakers. These are professionals with extensive backgrounds in sterile products who can share important information.”

Presenters include: Clyde Buchanan, retired director of pharmacy for Emory University; Laura Thoma, associate professor at the University of Tennessee, College of Pharmacy; Kara Duncan Weatherman, professor of nuclear pharmacy at Purdue University; Russ Madsen, president of The Williamsburg Group LLC and former president of PDA (Parenteral Drug Association); Doug Haugh, president of Bio-Med Consulting; and Ross Caputo, CEO of Pharmaceutical Systems, Inc.

“We’re also bringing international perspective to the topic,” says Jack Lysfjord, vice-president of Aseptic Process Consulting and co-chair of the conference track, “with speakers like Brian Metcalf and Phil Templeton from the United Kingdom.” Metcalf, with some twenty years of experience in the preparation of sterile products, has authored a book on isolators and their use. Templeton, a consultant with Aseptic Technology and Design, Ltd., will present a case study on an isolator that was developed for Baxter. “They’ve been using isolators for many years [in the U.K.], so perhaps we can become better educated by listening to them, and maybe we can grow faster because of it,” says Lysfjord.

The CleanRooms CCT Conference and Exhibition will take place March 15-16, 2006, in Boston, Mass. For more information, visit