PTI - international

I. Overview of Pharmaceutical Water Systems

• Define types of water for the manufacture of drug products
• Specify appropriate uses for each type of water
• Interpret USP and FDA guidelines for Purified Water (PW) and Water For Injection (WFI)
• Clarify how the FDA's GMP and Quality System Regulation requirements relate to water
  systems
• Evaluate EPA requirements

Discussion: Roles and Responsibilities

II. Identify Common Impurities and Sources of Contamination

• Differentiate among common impurities
• Identify sources of contamination
• Utilize key testing methods, such as TOC, conductivity and LAL
• Explore newer testing methods

Exercise: Identify the Appropriate Methods to Test for Specific Contaminants

III. Employ Pre- and Post-Treatments for Water Systems

• Evaluate sources of feed water and address corresponding requirements
• Identify and assess methods for pre-treatment
• Review USP's acceptable methods for producing PW and WFI
• Specify the principles and appropriate uses of ion exchange, distillation and deionization
• Examine Reverse Osmosis (RO)
• Compare additional methods of water purification, such as NF, UV/ozone
• Explore new trends and technologies

Exercise: Design, Test and Inspect a Water Treatment System

IV. Design a Compliant Water System

• Define roles and responsibilities of engineering, utilities, validation, QC, QA
• Outline important design considerations, such as bioburden control
• Evaluate your existing system's design and identify areas in need of improvement
• Examine common distribution loops
• Evaluate your system for potential dead-legs
• Identify roles of common equipment, including:
  • heat exchangers
  • distillation stills
  • holding tanks
• Evaluate materials (i.e., stainless steel vs. plastic), including necessary specifications

Exercise: Design a Working Water System