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Validation Of Pharmaceutical Compressed Gasses

Summary

  • Compressed Air Systems coverage
  • Selection of the compressed air systems
  • Major components of systems (schematics)
  • Criticality of major components
  • Qualification of compressed air systems
  • International standards and pharmacopeia testing specifications
  • International guidance
  • Validation of compressed air systems
  • Contamination potential examples (case studies) and prevention
  • Optimization, qualification and validation planning and implementation for post-expansion and/or post-changes
  • Nitrogen Systems coverage
  • Special considerations for design
  • Qualification of nitrogen systems

Other Gasses:

  • Argon,
  • Liquid Nitrogen,
  • Carbon Dioxide,
  • Cryogenic Storage Solutions,
  • Oxygen

 

  • Special considerations for design
  • Qualification of special gas systems

Overview

Compressed gasses are vital excipient and utility in pharmaceutical and bio-pharmaceutical industry. Their criticality to pharmaceutical and bio-pharmaceutical production sometimes overlooked. Their potential to be a source of clean room and product contamination seldom considered. This webinar will give you an understanding of different types of compressed gasses used in pharmaceutical and bio-pharmaceutical industry and their purpose, designs of these utility systems and their qualification and validation considerations as well as continued monitoring throughout life-cycles of these systems. We will also discuss possibilities of contamination types inherent in compressed air and other gasses systems and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed gasses system with their individual components will be provided.

Who should attend?

  • Quality Control
  • Quality Assurance
  • Production/Operations
  • Microbiologist
  • Chemist
  • Analysts
  • Manufacturing
  • Validation
  • Facilities
  • Materials Management
  • Engineering
  • Vendors/Suppliers
  • Regulatory Affairs
  • All levels of management

Igor Gorsky

Expert

Igor Gorsky, Sr. Consultant, ConcordiaValsource, LLC. He has over 30 years of experience leading validation, technology transfer, quality assurance and manufacturing functions in a wide range of pharmaceutical and biotechnology generic and brand firms. Prior to Concordia Valsource, Igor served as an Associate Director of Validation at Shire Pharmaceuticals where he oversaw validation activities for Shire Specialty Pharmaceuticals Supply Chain providing support to Shire owned sites as well as working closely with Shire’s numerous Contract Manufacturing Organizations. In addition, at Shire Igor was a member of Global Pharmaceutical Technology Leadership Team. At Wyeth Igor led Data Analysis group that was responsible for Knowledge Management and Understanding of multiple areas in development, validation and production of multi-billion dollar Branded Conjugated Estrogen Therapy franchise.

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