Validation of Pharmaceutical Compressed Gasses

Product Id IQW18L1207
Speaker Igor Gorsky
Level Intermediate
Duration 60 Mins
Schedule Thursday, December 13, 2018 | 11:30 AM PST | 02:30 PM EST
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  • Description
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Compressed gasses are vital excipient and utility in pharmaceutical and biopharmaceutical industry. Their criticality to pharmaceutical and biopharmaceutical 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 biopharmaceutical industry and their purpose, designs of these utility systems and their qualification and validation considerations as well as continued monitoring throughout lifecycles 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. Typical engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered critical and optimal. The sample contamination sources in compressed gasses that will be discussed are:
                • Solid particulate
                • Water content
                • Total oil content
                • Microbial bioburden

Recommendations will also be provided for preventing contamination. Additionally, points to consider for post-expansion and/or post-changes for optimization, qualification and validation planning and implementation are also covered. A compilation of all FDA/EU GMP guidelines, USP/EP and ISO (8573, 7183, 12500) standards will be presented. Sampling and testing methodology for these specifications will be discussed as well. Finally, case studies describing compressed gasses use related deviations will be covered.

•             This course is designed for non-engineering pharmaceutical and biopharmaceutical professionals to provide learning fundamentals of compressed air systems selection, installation, qualification, validation and continued monitoring.

•             This course will also help non-engineering personnel understand workings of day-to-day compressed gasses’ systems operations, as well as provide necessary basics of criticality of these systems to the overall quality of pharmaceutical and biopharmaceutical processes and products.

•             Additional benefits include presentation of the most significant points to consider whilst planning and implementing compressed gasses systems’ expansions and/or changes including optimization, qualification and validation recommendations.  

•             Compressed gasses used in the pharmaceutical and biopharmaceutical industry and their uses

•             Compressed Air Systems coverage

               o            Selection of the compressed air systems

               o            Major components of systems (schematics)

               o            Criticality of major components

               o            Qualification of compressed air systems

               o           International standards and pharmacopoeia testing specifications

               o            International guidance

               o            Validation of compressed air systems

               o           Contamination potential examples (case studies) and prevention

               o           Optimization, qualification and validation planning and implementation for post-expansion and/or post-changes

•             Nitrogen Systems coverage

              o            Special considerations for design

              o            Qualification of nitrogen systems

•             Other Gasses:

              o            Argon

              o            Liquid Nitrogen

              o            Carbon Dioxide

              o            Cryogenic Storage Solutions

              o            Oxygen

              o            Special considerations for design

              o             Qualification of special gas systems

  • Quality Assurance
  • Quality Control
  • Validation
  • Production/Operations
  • Engineering
  • Technical Services

Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and the introduction of new products onto the market. He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition, he had been a presenter at Interphex. He is also very active with PDA participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.

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