Certification of Sterile Compounding Facilities

May 13-15, 2025

This three-day pharmacy cleanroom certification training program uses lectures, hands-on workshops, and group activities to provide a review of the facility design, and environmental control requirements of USP Chapter <797> and the NIOSH Alert. The “Engineering Control Performance Verification” section of USP <797> is covered in detail. The specific certification procedures outlined in the Controlled Environment Testing Association’s (CETA) CAG-003 are also discussed and utilized for the course’s hands-on workshops. In addition, CAG -001 and CAG-002 will be examined and utilized for the certification of compounding aseptic isolators.

Compliance with these pharmacy cleanroom guidelines is crucial for pharmacy safety.

Who Is This Class For?

  • Certifiers
  • Cleanroom Designers
  • Cleanroom Contractors
  • anyone designing or building cleanrooms for sterile compounding
Details
DATE

May 13-15, 2025
TIME 08:00 - 05:00 EST
LOCATIONBethlehem, PA
Total

$2,495.00

Categories: ,
Agenda
Day One

  • USP <797> Sterile Compounding Standards
  • NIOSH Alert for Preventing Occupational
  • Exposure to Antineoplastic & Other Hazardous Drugs
  • USP <797> and NIOSH Specific Facility Requirements
  • Engineering Controls
  • Counting Total Particles and Non-Viable Particles in USP<797> Cleanrooms
  • Gowning Requirements

 

Day Three

  • Workshop: Execution of Test Plan for a Real-World Cleanroom
  • Certification of Vertical and Horizontal Laminar Flow Benches, including Airflow Testing, Particle Counting, Environmental Monitoring and HEPA Filter Leak Testing
  • Activity: Review of Test Documentation
  • Isolator Descriptions and Background
  • Isolator Testing
 Day Two

  • Workshops: Gowning and Fingertip Sampling, Smoke Pattern Testing, Documentation
  • Workshops: Viable Sampling, Total Particle Count, Smoke Pattern Testing
  • Cleanroom Concepts and Testing Procedures: Facility Objectives, Airflow Testing, Room Segregation, HEPA Filter Integrity Test, Problem Sets
  • Activities: Developing Test Plans for Real-World Locations, Activity: Review of Test Plans
Instructors
Erin Thane
Erin Thane
Vice President, Azzur Labs
Mark St. Marie
Mark St. Marie
CIH, RCP-SCF, Director of Business Development ,Eurofins Built Environment Testing USA Analytics
Jeff Smith
Jeff Smith
Sr. Manager, Training & Technical Services - Controlled Environment Services Inc.| Life Sciences A Subsidiary of STERIS Corporation
Tuition

Tuition of $2495 must be paid in full to guarantee a space in the class.

Tuition Includes: course manual, lunch each day, an Eagleson Institute certificate and a special class reception and dinner with plenty of time to network with peers and instructors.