Certification of Sterile Compounding Facilities and Aseptic Isolators for Compliance with USP Chapter <797> and the NIOSH Alert

Learn how to develop certification strategies for sterile compounding facilities and equipment based on an in-depth understanding of the USP and NIOSH guidelines

COURSE DESCRIPTION

This four and a half-day class uses lecture, hands-on laboratory work 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 Chapter <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.  Due to the personalized instruction offered, this course is limited in size.  Following this class, participants are offered the opportunity to take the CETA Registered Cleanroom Certification Professional Written and Practical exams.

Please note: CETA must receive your application 45 days in advance of the exams.

PARTICIPANTS WILL LEARN

• Sterile compounding facility design and environmental controls requirements.
• How to establish cleanroom “state of control” points.
• How to establish cleanroom “performance objective” parameters.
• How facility design impacts test choices.
• The difference between flow control vs. dilution control.
• How to perform airflow smoke pattern testing.
• How to perform viable and non-viable environmental sampling.
• How to apply airflow measurement techniques for cleanrooms.
• How to calculate room air exchange rates.
• How to develop strategies for room segregation testing.
• Appropriate applications for mixed flow cleanrooms.
• How to test compounding aseptic isolators to appropriate standards.

WHEN AND WHERE

2012 Dates:

• May 7-11, 2012
  Call 207-490-1076 for more information and registration
• October 1-5, 2012
  

This course is offered at the STAR Center in Englewood, Colorado.  Note: The CETA Registered Cleanroom Certification Professional Written and Practical exams will be administered following these classes on May 12^th and October 6^th.  Application and Support Document Deadlines are March 23^rd and August 17^th respectively.

To register for this exam, contact CETA at (919) 861-5576 or visit www.cetainternational.org for more information.

COMPANION COURSES

Advanced Certification

THIS COURSE IS FOR:

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

“All workshops are extremely useful and instructors were very willing to share real life working experience and tips.” 2011 class participant

INSTRUCTORS

Jim Wagner, Principal, Controlled Environment Consulting. Jim is the lead instructor. He has served on the 2005-2010 expert committees to the United States Pharmacopeial Convention which was responsible for changes to USP Chapter 797.  Jim is currently a member of the 2010-2015 USP Compounding Hazardous Drugs expert committee.   Jim will be joined by Jeff Smith, President, Agape Instrument Services, Inc., Kym Faylor, President, Azzur Laboratories; and Aaron Johnson, Engineering Test Supervisor, The Baker Company

REGISTRATION

Tuition of $2295 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.  Tuition does not include CETA exam fees.

AGENDA

DAY 1

• Overview of USP Chapter <797> Sterile Compounding Standards
• Overview of NIOSH Alert for Preventing Occupational Exposure to Antineoplastic and 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 for USP <797> and the NIOSH Alert
• Workshops: Gowning, Fingertip Sampling
• Smoke Pattern Testing
• Documentation

DAY 2

• 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 3

• Activity:  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 Laminar Flow and Horizontal Laminar Flow Benches, Including: Airflow Testing, Particle Counting, Environmental Monitoring, HEPA Filter Leak Testing
• Activity:  Review of Test Documentation

Day 4

• Isolator Descriptions and Background
• Isolator Testing
• Activity: Establishing a Test Plan

Day 5

• Workshop: Certification of Isolators
• Activity: Certification Documentation Review