Dr. Soli’s April 12 presentation, entitled “USP Position on WFI Production Methods”, reviews results of the USP’s recent industry survey on current practices for making WFI water using non-distillation methods. The USP survey collected data from pharmaceutical firms now using non-distillation approaches to produce WFI-quality water. Areas he will report on will include source water issues, purification train unit concerns, sanitization approaches, and meeting WFI specs, among others. Current USP guidelines define WFI as water purified by distillation or a purification process that is equivalent for the removal of chemicals, and microorganisms. Dr. Soli is a member of the USP Chemical Analysis Expert Committee, which is responsible for pharmaceutical water, and is a past vice chair of the USP Pharmaceutical Waters Expert Committee.
In addition to Dr. Soli’s presentation, other highlights of the meeting will include a keynote address by Mr. Mark Hassenplug of Ernst & Young, who will report on business aspects of the pharmaceutical industry, and Ms. Anita Michael of the FDA, who will report on the agency’s view and approach to water system validation. On both days the conference will also include technical presentations on important topics related to pharmaceutical water. Examples will include monochloramine removal, UV treatment, ozone sanitation, on-line water testing, a novel ion-exchange process, and enduser case reports.
Also, on Wednesday, April 13, attendees will have the option to attend a workshop taught by Dr. Soli entitled, “Mastering Biofilm Control in Pharmaceutical Water Systems.” The training workshop will cover issues such as the basics of microbial monitoring and control, and information about biofilm and successful and not-so-successful biofilm control methods. Dr. Soli will also explain the USP’s public comment and revision process, and the USP’s role in regulating water used by the pharmaceutical industry.
Conference attendees will have the opportunity to network with others active in the pharmaceutical water field. Other benefits from attending the conference will be the opportunity to learn from experts with direct experience with the USP and FDA, as well as from technical experts actively involved with technologies used to treat pharmaceutical-
Co-moderators of the conference will be Mr. Joseph Manfredi of GMP Systems, and Mr. William Collentro of Worcester Polytechnic Institute.
On-line registration is available at http://www.talloaks.com/
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ULTRAPURE WATER On-Line is a journal that since 1984 has published more than 1,700 technical articles. The on-line journal publishes articles key to water professionals and water executives, and is the voice for water treatment technology and business information. In addition to conferences, ULTRAPURE WATER On-Line offers a water treatment bookstore with books on key technologies used in industrial and high-purity water treatment. More information is available at www.ultrapurewater.com.