HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms
Product Id : FDA18Download Conference Material
Description
Overview
Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. 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.
Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.
It is important that a clean room'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. This webinar first details and explains the various US and international regulatory requirements for various clean room classifications.
Next, the webinar provides a comprehensive overview of the mechanics of clean room HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Clean room 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 clean room.
The principles of HEPA filtration are described along with desired clean room 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.
Comprehensive procedures for cleaning and sanitization of the clean room environment are presented along with a review of the best disinfectants currently available along with their respective advantages and disadvantages. The subject of clean room 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.
Learning Benefits:
- 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
- Personnel Gowning and Aseptic Practices in Clean Room
- HVAC System Validation
Who Should Attend:
- Quality Assurance
- Environmental Monitoring
- Microbiology
- Manufacturing
- Validation
- Designers
- Engineering
- Maintenance
Speaker Profile:
Roger Cowan is the owner of R Cowan Consulting Services LLC, which is a consulting firm which specializes chiefly in pharmaceutical contract manufacturing. He has been working in the field of pharmaceutical quality assurance and manufacturing for over 37 years, and in this time, he has held important positions in QC Laboratory, Quality Assurance, Manufacturing, Technical Services Validation, and Clinical Supply Manufacturing and Distribution.
He has taught microbiology courses at the Seneca College in Toronto, Canada, as part of the Pharmaceutical Technology Program. In addition, he has conducted webinars on various subjects, providing invaluable training to thousands of people across the nation.
His areas of expertise include quality assurance and control, environmental monitoring, contamination control, product sterilization, regulatory submissions, regulatory requirements, aseptic pharmaceutical manufacture, GMP facility audits, microbiology, process development, process validation, technical transfer, clinical supply manufacturing, and labeling and distribution (both US and international).
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