HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Nov 03, 2016
90 minutes
Product Description

Expert Guidance on Clean Room HVAC System Design, Monitoring and Validation

For manufacture of quality product, environmental control of pharmaceutical clean rooms is important. The control of conditions such as air velocity, airflow, personnel, differential pressure, humidity, temperature, microorganisms and airborne particulate is critical to safeguard the product from contamination.

Therefore, the validation, ongoing monitoring and design of a clean room HVAC system are essential to assure the safety and quality of the pharmaceutical product. Also, according to international regulatory standards, a proper testing and understanding of the clean room environment is crucial from a compliance perspective.It is essential that the clean room’s HVAC system is properly validated and designed and fully understood. If this is successful, it will provide the environmental control essential to meet the regulatory particulate and microorganism levels needed to manufacture quality pharmaceutical products.

This webinar by expert speaker Roger Cowan first details and explains the various US and international regulatory requirements for various clean room classifications. Further, it provides expert guidance and best practices in HVAC and GMP environmental control for pharmaceutical clean rooms.

Session Highlights:

  • Get a comprehensive overview of the mechanics of clean room HVAC, which includes engineering diagrams and schematics.
  • Get a detailed analysis of HVAC equipment components, automated control systems and clean room design considerations.
  • Learn why proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.
  • The principles of HEPA filtration, desired clean room airflow patterns and how to achieve them.
  • Proper procedures for HEPA filter leak testing.
  • Get valuable information on air pressure balancing, flow rates, air velocity, and differential pressure.
  • Details on temperature and relative humidity controls and specifications.
  • A full review of all current air monitoring systems for non-viable particulate and microorganism measurement.
  • Comprehensive procedures for cleaning and sanitization of the clean room environment.
  • Review of the best disinfectants currently available along with their respective advantages and disadvantages.
  • Avoiding clean room contamination due to personnel—gowning techniques and aseptic practices.
  • Get details of a full set of requirements for HVAC system validation.
  • Ongoing monitoring of the clean room environment, including schedule, specifications and OOS (out-of-spec) actions that may be required.

Session Agenda:

  • GMP Compliance of Clean Room Environment
  • Regulatory Clean Room Classification and Requirements
  • HVAC System Components
  • Clean Room Design and Layout
  • HEPA Filtration
  • Differential Pressure and Air Pressure Balancing Considerations
  • Temperature and Humidity Controls
  • Cleaning and Disinfection
  • Non-Viable Particulate Monitoring Systems
  • Microbial Monitoring Systems
  • Personnel Gowning and Aseptic Practices in Clean Room
  • HVAC System Validation

Who Should Attend

This webinar will provide valuable assistance to all personnel in:

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Roger Cowan - Pharmaceutical Contract Manufacturing

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 37 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology...   More Info
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