Compliance Key INC - Medical Device Training
Roger Cowan
Roger Cowan is the Keynote Spaker at Compliance Key Inc. He 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 35 years experience in pharmaceutical quality assurance and manufacturing.
Overview
Environmental control of pharmaceutical clean rooms 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.
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.
Why should you attend this webinar?
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.
All current air monitoring systems for non-viable particulate and microorganism measurement are fully reviewed.
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. Ongoing monitoring of the clean room environment is discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.
Areas Covered in the Session:
- 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 can Benefit:
- Quality Assurance
- Environmental Monitoring
- Microbiology
- Manufacturing
- Validation
- Engineering
- Maintenance
Compliance Key INC
717-208-8666
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