Designing a USP-797 and USP-800 Compliant Compounding Pharmacy

With the recent Drug Quality and Security Act, now is the time to become proactive with FDA inspections. Stop contamination before it starts. Implementing a sterile compounding pharmacy begins with designing a compliant cleanroom. In this course, you will learn design and environmental control of a compounding pharmacy that is in compliance with USP 797 requirements and proposed USP 800.

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 IEST-RP-CC012.3: Considerations in Cleanroom Design
• Copy of PowerPoint presentation in course binder
• Certificate of attendance for completion of CEUs

This Recommended Practice (RP), IEST-RP-CC012.3, makes recommendations regarding factors to consider in the design of cleanroom facilities. The RP is limited to those environmental conditions that typically confront cleanroom designers and users. The RP is intended to provide users with a means to establish performance criteria for cleanrooms.

Continuing Education Units: .6 CEUs


Calendar of Events