Basics of Designing a USP 797 Compliant Compounding Pharmacy
This course is available as a custom location training option for your facility.
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 the basic considerations for the design and environmental control of a compounding pharmacy that is in compliance with USP 797 requirements.
Course outline Who should attend? Course materials Instructor Next date and location Registration
Course outline
- Facility layout and dimensions
- Facility materials and sealing
- Environmental controls
- HEPA/Return locations
- Temperature, pressure, and humidity monitoring
- HVAC system types
- Floors, walls, doors, sinks, and other considerations
- Design for testing compliance rational
- Operation and maintenance
- FDA inspections of pharmacies and what needs to be done to comply with their inspection recommendations
- Questions and answers
Who should attend?
I need to learn how to design a cleanroom that is USP 797 compliant because:
- I am an architect designing a new cleanroom
- I am a pharmacy owner, hospital manager, or building manager
- I am interested in learning the fundamentals of 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-CC012.2: Considerations in Cleanroom Design
- Copy of PowerPoint presentation in a course binder
- Certificate of course attendance with completion of CEUs
This Recommended Practice (RP), IEST-RP-CC012.2, makes recommendations regarding factors to consider in the design of cleanroom facilities. The RP is intended to provide users with a means to establish performance criteria for cleanrooms. This discussion focuses on those environmental conditions that typically confront cleanroom designers and users. The document includes a sample cleanroom construction protocol.
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.
Next scheduled date and location
TBA