Editorial

Objectives

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. This webinar will:

• Detail and explain the various US and international regulatory requirements for cleanroom classifications.
• Provide a comprehensive overview of the mechanics of cleanroom HVAC including engineering diagrams and schematics, and:
  • HVAC equipment components will be detailed as well as the automated control systems that are available.
  • Cleanroom design considerations will be discussed.
  • How proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the cleanroom.
• Describe the principles of HEPA filtration along with:
  • Desired cleanroom airflow patterns and how to achieve them.
  • Proper procedures for HEPA filter leak testing.
• Provide valuable information on differential pressure, air velocity, flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications will also be detailed.
• Review all current air monitoring systems for non-viable particulate and microorganism measurement.
• Present comprehensive procedures for cleaning and sanitization of the cleanroom environment along with a review of the best disinfectants currently available along with their respective advantages and disadvantages.
• Discuss the subject of cleanroom contamination due to personnel including both gowning technique and aseptic practices.
• Detail a full set of requirements for HVAC system validation. Ongoing monitoring of the cleanroom environment will be discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required

Program

• 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

Speakers

Roger Cowan
Pharmaceutical Consultant, R Cowan Consulting Services LLC

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 35 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada.

His areas of expertise 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.