Pharmaceutical Water Generation (T04)

Level: Intermediate
ISPE CEUs: 1.5
Type: Classroom Training Course
Includes Webinar

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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 diluent. In addition to non-compendial systems, pharmaceutical facilities typically include systems for generating USP Purified Water (PW) and USP Water-For-Injection (WFI). This course has been substantially updated to feature the guiding principles of the newly released ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control and laboratory water as well as key design philosophies. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems used to generate USP and non-compendial waters will be covered. 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.

Course Modules

• Intro & Regulatory Background
• Planning & Programming
• Basic Water Chemistry
• Feed Water Characterization
• Basic System Review
• Pretreatment Processes
• Reverse Osmosis
• Deionization Processes
• Ultrafiltration
• Distillation
• Purified Water Systems
• Water for Injection Systems
• Non-compendial Systems
• Laboratory Water Systems
• Pharmaceutical Steam
• Appendices
• Exercises

Includes Webinar 

This course includes a pre-recorded Webinar that provides a review of the basics prior to the classroom course. Access information will be provided via email one week prior to the start of the training event.

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 system

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, non-compendial and laboratory  water systems
• Define the fundamentals of various generation system alternatives
• Ability to defend and critique design, operation and maintenance practices with the ability to identify issues and troubleshoot component

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 that now have water generation system engineering and/or maintenance responsibilities and want to gain an essential 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 an essential understanding of pharmaceutical water generation systems and learn detailed process design parameters.
• Those with significant pharmaceutical water experience who want understand current industry trends and ISPE consensus views.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Critical Utilities Community of Practice (COP).

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element Production Systems: Production Unit Operations - Drug (small molecule) and Biologics. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.