• Introduction to HVAC systems
  • History of HVAC
  • Major Uses
  • The science behind HVAC systems
  • Working principles of HVAC
• Design of Air Handling Units
  • HVAC design challenges
  • The Psychrometric table and charts
  • Main components of an HVAC System
  • Heat Exchangers, Fans and Duct Systems
  • Configuration of Air handling systems
  • Equipment Selection
  • Examples
• Air Filtration for Quality Control
  • Methods of air distribution and extraction
  • Types of filters
  • Filtration processes
  • HEPA Testing and certification
• Facility Design for Particle Control
• Facility layout and typical controlled area specifications including OSD and Laboratories
• Design features for dust  and contamination control and prevention of cross-contamination
• Differential Pressure  and  Airflow regimes
• Use of barrier systems and unidirectional airflow devices  (PLF)
• Exercise

Day 2

• Qualification of HVAC Systems and Room Environments
  • Risk-based approach
  • Impact and Quality Risk Assessments
  • Design Qualification
  • P&ID Symbols and How to read it for an HVAC systems
  • IQ/OQ/PQ
  • Documentation examples
  • How should a protocol look like
• Maintaining the Validated State
  • Change Management
  • Ongoing Quality Risk Management
  • Continuous Improvement
  • Non-Conformance Management
• Particle Monitoring
  • How optical particle counters work
  • Particle counting technology (including airborne rapid micro sampler and how they work)
  • Classification vs. monitoring of clean zones
  • Classification worked examples
  • FDA CGMP & EU GMP Annex 1
  • Monitoring systems
  • Understanding particle monitoring data
• Microbial Monitoring
  • What has to be monitored and when?
  • Routine and periodic monitoring requirements
  • Differences between Aseptic and Non-Sterile Areas
  • What equipment is needed?
  • Where should we monitor?
  • What standards should be applied?
  • Location and frequency examples
  • Effective data management and reacting to data
• Summary