Class 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
USP <797> Viable Particle Counting
Gowning Requirements
Workshops: Gowning and Fingertip Sampling, Smoke Pattern Testing, Documentation

DAY TWO

Workshops: Viable Sampling, Non-Viable Sampling, Smoke Pattern Testing
Cleanroom Concepts and Testing Procedures: Facility Objectives, Airflow Testing, Room Segregation, HEPA Filter Integrity Test, Problem Sets
Site Visit To Local Hospital

DAY THREE

Activities: Developing Test Plans for Real-World Locations, Activity: Review of Test Plans
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

DAY FOUR

Isolator Descriptions and Background
Isolator Testing
Activity: Establishing a Test Plan
Workshop: Certification of Isolators
Activity: Certification Documentation Review

Certification of Sterile Compounding Facilities and Aseptic Isolators

May 16-19, 2023 | St. Louis, MO

This four day class uses lecture, 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 -001-2005 and CAG-002-2006 will be examined and utilized for the certification of compounding aseptic isolators.

Who Is This Course For?

Certifiers, Cleanroom Designers, Cleanroom Contractors and anyone designing or building cleanrooms for sterile compounding.

Course Instructors

The lead instructor for this course is Jim Wagner, Principal, Controlled Environment Consulting.

Other instructors include:

Erin Thane, Senior Director of Lab Services- PA, Azzur Labs
Mark St. Marie, Prinicpal Consultant, Progeny Consulting Group, LLC
Jeff Smith, Sr. Manager, Training & Technical Svcs., Controlled Environment Services Inc.| Life Sciences, A Subsidiary of STERIS Corporation

Course 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.