USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.

USP Pharmaceutical Waters

Course
Mumbai, India, March 21-22, 2016
Hyderabad, India, March 24-25, 2016
Dr. Anthony Bevilacqua and Dr. Teri Soli

Copyright® 2016 U.S. Pharmacopeial Convention

(USP)12601 Twinbrook Parkway, Rockville, MD 20852
All rights reserved. USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
 About the Instructors

Anthony C. Bevilacqua, Ph.D. is the Head of Research and Development at Mettler-

Toledo Thornton. Dr. Bevilacqua earned a doctorate in Analytical and Physical
Chemistry from Tufts University. He has been at Thornton since 1994, leading Thornton
in the development of analytical techniques, specializing in ultra-low detection methods in
high purity waters, improved high temperature conductivity measurements, the impact of
CO2 on pure water, use of ultrapure water (UPW) as a conductivity solution standard, and
the expansion of measurement parameters (TOC, microbes, ozone, sodium, and silica,
etc… ) to the company’s process analytics portfolio.

Dr. Bevilacqua was the conductivity consultant to the USP during the implementation period for the 645
and 643 in the mid-1990’s, and he established the theory, methods, and practices used for conductivity
testing of Purified Water and WFI. Anthony was Chair of the first USP Pharmaceutical Water Expert
Committee from 2000-2005, and again in 2005-2010. He has been cooperating with EP, JP and other
Pharmacopeias on international harmonization of pharmaceutical water quality standards. Today, Anthony
serves on the USP Chemical Analysis Expert Committee (2010-2015 and 2015-2020), he is Chair of the
USP Sterile Water Expert Panel, he is on the steering committee for the ISPE Critical Utilities Community
of Practice, and has contributed to numerous ISPE Guides and volunteer-led meetings.

USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
 About the Instructors

Teri C. (“T.C.”) Soli, Ph.D. is principal of Soli Pharma Solutions, a consulting company
with more than 36 years of pharmaceutical experience beginning with DSM, Catalytica,
Glaxo Wellcome, Burroughs Wellcome, and Pfizer including the last 12 years as an
independent consultant. Consulting expertise focuses on microbial and chemical control
of water and steam systems, chemical and microbiological analytical development,
sterilization validation, QA/QC labs, regulatory affairs, & training. Dr. Soli holds a
Doctorate in Microbiology and Immunology from the University of Arizona.

Dr. Soli was a member of the PhRMA Water Quality Committee that collaborated with USP in the 1990’s to
revolutionize its water monographs with Total Organic Carbon <643> and Water Conductivity <645>
specifications and the first of several significant rewrites of its informational chapter <1231>, all of which
are now utilized world-wide. Dr. Soli was a member of the first USP Pharmaceutical Water Expert
Committee from 2000-2005, and Vice-Chair from 2005-2010. Today, T.C. serves on the USP Chemical
Analysis Expert Committee (2010-2015 and 2015-2020) and is Chair of their Pharmaceutical Water Sub-
Committee. He is currently Chair of the Combined Pharmaceutical Waters Expert Panel through which
USP’s informational chapter on water <1231> is being further updated, USP’s many non-monographed
analytical waters are being contemporized, and pharmaceutical water quality standard harmonization with
EP and JP is being spearheaded. T.C. is also on the steering committee for the ISPE Critical Utilities
Community of Practice, has coauthored numerous ISPE and PDA Guides, and has written chapters on
water system biofilm control in several books published by PDA.

USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
 Day 1 Course Agenda

 Introduction to USP and Expert Committee

 Water, Water Systems and Water Chemistry 101
 Overview of PW and WFI Monograph
Requirements
 Overview of "Sterile Water" Monograph
Requirements
 Overview of Pure Steam and Water for
Hemodialysis Monograph Requirements

USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
 Day 1 Course Agenda (continued)

 Biofilm and Its Effect on Water System Purification

Operations
 Water System Microbial Control and Sanitization
Methods
 Microbial Test Methods for Water
 Tests and/or Workshops

USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
 Day 2 Course Agenda

 Conductivity
 645 Water Conductivity
 Total Organic Carbon
 643 Total Organic Carbon

USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
 Day 2 Course Agenda (continued)

 Endotoxins
 Validation of Pharmaceutical Water and Steam
Systems
 1231 Water for Pharmaceutical Purposes
 FAQs

USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.
USP Pharmaceutical Waters Course – March 2016 COPYRIGHT© 2016. ALL RIGHTS RESERVED.