Pharmaceutical Water Systems: Part 1 - Design, Operation & Qualification

About the Course

Water is one of the most critical utilities in pharmaceutical manufacturing, directly impacting product quality and patient safety. This comprehensive module, is designed to equip drug inspectors and auditors with a strong foundational understanding of pharmaceutical-grade water systems, focusing on both technical and regulatory perspectives.

Content

• Sources of Water & Types of Impurities
  • Sources of water
  • Underground water and supply of borewell water
  • Dissolved and suspended impurities
  • TDS & TSS
• Water and Applications
  • Key for pharmaceutical manufacturing
  • Regulated water qualities
  • Common grades of water
  • Water types– quality parameters
  • Selection of water for pharmaceutical Purposes
  • Water quality specifications
• Purification Techniques and Common Issues
  • Purified water
  • Primary treatment of water
  • Source water to potable water
  • Multigrade filtration
  • Multi grade filters, prefilters, Cartridge filters
  • Softeners, Additives, and Ion exchangers
  • Activated Carbon Filtration
  • Reverse osmosis – Principle, Usage and Advantages
• Purified Water Generation and Specification
  • Purified water (USP/EP/JP/IP)
  • Purified water generation
  • Electrodeionization
  • Ozonated water loop
  • Purified water specification

Summary and Conclusion: Life cycle management of Water Systems

Final Evaluation: 3 attempts to achieve the passing score in the evaluation.