Pharmaceutical Water Generation (Includes Webinar)

ISPE CEUs*: 1.5 (including webinar)
Type: Classroom Training Course

Upcoming Dates and Locations

Date

Location

Country

Instructor(s)
22-23 September 2008 New Jersey Classroom Training Series
Someret, NJ		 United States Gary Zoccolante

Description

Pharmaceutical water is perhaps the most important of all pharmaceutical utilities. It is used as an excipient in many pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluents. In addition to non-compendial systems, pharmaceutical facilities typically include systems for generating USP Purified Water (PW) and USP Water-For-Injection. 

This course covers the principles of design and operation of water systems used directly in pharmaceutical manufacturing, including the fundamental concepts and principles of systems used to generate USP and non-compendial waters. These concepts include specification, design, operation, testing, and maintenance of equipment and systems for water generation. Participants will examine methods for proper water quality selection, information on compendial and non-compendial waters, fundamentals of basic water chemistry, and information on common unit operations (deionization, reverse osmosis, and distillation). Pre-treatment systems, detailed guidance for selection of construction materials, and operations issues related to pharmaceutical water generation systems will also be discussed.

The course will also cover regulatory requirements including USP, EP, and JP Monographs, the FDA Guide to Inspections of High Purity Water Systems, current FDA views, and current Good Manufacturing Practice (cGMP) requirements. Common water system myths will also be explored and a variety of practical system designs will be evaluated for USP and FDA compliance, as well as their advantages and disadvantages. Particular attention will be paid to system and component sanitization procedures and microbial control.

Participants will receive a complimentary copy of the Water and Steam Systems Baseline® Guide and the Good Practice Guide: C&Q of Water and Steam.

This course contains knowledge related to the CPIPSM technical knowledge competency elements Facilities and Equipment and Production Systems. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.  

Webinar Learning Objectives

  • Discuss regulatory requirements, current FDA views and current Good Manufacturing Practices (cGMP) as they relate to pharmaceutical water systems 
  • Explain the effect of the cGMPs, FDA guidance documents, ISPE Baseline® Guides, and other reference documents on water system design, construction, maintenance and validation 
  • Compare common water process design alternatives for USP PW and WFI systems

Take Back to Your Job

  • Differentiate regulatory requirements from regulatory myths relative to water treatment systems
  • Apply the fundamentals of basic water chemistry
  • Identify detailed unit process performance characteristics and design parameters
  • Understand fundamental water quality requirements and the difference between compendial and non-compendial water systems
  • Define the fundamentals of various generation system alternatives

Attendance Suggested For

  • Pharmaceutical professionals who are new to water treatment systems or those with significant engineering expertise from another industry who need to learn about pharmaceutical water treatment systems.
  • Those with significant industry experience in other capacities who now have water generation system engineering and/or maintenance responsibilities and want to gain a fundamental understanding of the requirements for designing, building, operating, testing, and maintaining these systems.
  • Water treatment systems quality assurance and quality control specialists, manufacturing supervisors, technical support personnel, and all levels of management who want to gain a fundamental understanding of pharmaceutical water generation systems.
  • This training course is of particular interest to existing and future members of the ISPE Critical Utilities Community of Practice (COP).