Course outline     Who should attend?     Course materials

Course outline

• Cleanroom and ante room layout
  ◦ Doors
  ◦ Hoods
  ◦ Sinks
  ◦ HEPA filters
  ◦ Lights
  ◦ Floors
  ◦ Walls
  ◦ Exhaust
  ◦ Pass-thru
  ◦ Ceiling
  ◦ Returns
• Primary engineering controls
  ◦ Clean benches, vertical/horizontal
  ◦ Biosafety cabinets class II-A, II-B, II-C
  ◦ Compounding aseptic isolators (CAI) and compounding aseptic containment isolators (CACI) vented or recirculated
  ◦ Exhaust systems, fans, and ducts
  ◦ HVAC, plenum vs ducted
  ◦ Cleanzones proper design and testing
• Continuous monitoring
  ◦ Temperature
  ◦ Relative humidity
  ◦ Pressure
  ◦ Particulate
  ◦ Microbial air
• Periodic monitoring
  ◦ Microbial air
  ◦ Swab/touch plate
  ◦ Control samples
  ◦ Sterilization
• Design for testing
  ◦ HEPA test ports
  ◦ Velocity/volume tests
  ◦ Particulate
  ◦ Hood types and locations
  ◦ Pressure
  ◦ Humidity and temperature
  ◦ ACPH
  ◦ Smoke tests
  ◦ Penetration
  ◦ Documentation
• Special USP-800 considerations
  ◦ Floor separations
  ◦ Special hoods
  ◦ Special exhaust systems
  ◦ Testing changes
  ◦ Storage
  ◦ Monitoring
  ◦ Additional documentations

Who should attend?

• I am an architect designing a new cleanroom
• I am a pharmacy owner, hospital manager, or building manager
• I am interested in learning advanced cleanroom design and construction
• I am a certifier or manager of a certification company who wants to learn how cleanrooms are built.

Course materials

• Copy of PowerPoint presentation sent electronically
• Attendees will earn a Certificate of Completion with CEUs based on request.


Continuing Education Units: .6 CEUs


See Training Course Schedule/Calendar