USP 797

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.

This course is available as a custom location training option for your facility.

Course outline     Who should attend?     Course materials     Instructor     Next date and location


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


Instructor

Rick Meyer
Mr. Meyer has over 35 years of construction, design, installation, consulting, repair, certification, and maintenance of laboratories, clean rooms, and filtration systems. He has currently been employed with Superior Laboratory Services, Inc. for the last 16 years. He has designed, built, consulted, and certified over 100 USP-797 facilities since 2004, and has tested/certified over 2000 clean rooms, designed/built over 900 clean rooms, and certified over 75,000 hoods to date. He is on IEST Working Groups related to HEPA leak testing, nano facility design, nano- safety, and USP-797 facility design. He is currently a member of the USA, ISO-14644 TAG team that performs reviews and comment on those standards prior to them becoming world wide standards. Mr. Meyer has worked as an Inspector for the State of Texas Pharmacy Board for the last two years.

Next date and location

No courses are currently scheduled at this time.