HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

Duration: 60 Minutes
This webinar details and explains the various US and international regulatory requirements for various cleanroom classifications. Environmental control of pharmaceutical cleanroom is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.
Cleanroom Monitoring System
Instructor: Roger Cowan
Product ID: 501231
Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the cleanroom environment according to international regulatory standards is important from a compliance perspective.

Objectives of the Presentation
  • GMP Compliance of Cleanroom Environment
  • Regulatory Cleanroom Classification and Requirements
  • HVAC System Components
  • Cleanroom 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 Cleanroom
  • HVAC System Validation
Why Should you Attend
It is important that a Cleanroom's HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

The webinar provides a comprehensive overview of the mechanics of cleanroom HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Cleanroom design considerations are included. Proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the Cleanroom.

The principles of HEPA filtration are described along with desired Cleanroom airflow patterns and how to achieve them. Proper procedures for HEPA filter leak testing is included. The webinar then provides valuable information on differential pressure, air velocity, flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications are also detailed.

All current air monitoring systems for non-viable particulate and microorganism measurement are fully reviewed. Comprehensive procedures for cleaning and sanitization of the Cleanroom environment are presented along with a review of the best disinfectants currently available along with their respective advantages and disadvantages.

The subject of Cleanroom contamination due to personnel is discussed. This includes both gowning technique and aseptic practices. Finally, a full set of requirements for HVAC system validation is detailed. Ongoing monitoring of the Cleanroom environment is discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.

Who can Benefit
This webinar will provide valuable assistance to all personnel in:
  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance
$375
Recorded Session for one participant
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Live Session - How it works
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  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Roger cowan has 32 years of experience in pharmaceutical R&D, manufacturing and QA management. He has established his own Consulting Services LLC, (http://www.pharmaconsultation.com/), Presently he is a Independent consulting to the pharmaceutical industry primarily in the area of pharmaceutical. His specialties include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US /international regulatory requirements, regulatory submissions, and quality assurance/control.
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