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Sterile Compounding Training Center

 
Sterile Compounding
 
 
With the evolution of pharmacogenomics and personalized medicine, sterile compounding has become an emerging area of growth due to its ability to provide customized medication dosage and delivery that fits the individualized needs of a specific patient or patient population. Pharmacists must be trained in and compliant with US Pharmacopeia Chapter <797> guidelines in order to dispense compounded medications, and this compliance has come under considerable scrutiny in the wake of public health concerns involving several compounding pharmacies that dispensed contaminated medications that led to tragic results.
 
The Daniel and Martina Lewis Center for Healthcare Innovation and Technology, in collaboration with Critical Point, LLC, delivers a program that provides high-quality, cost-effective professional development and networking opportunities. We believe that the best way for pharmacists and other compounding professionals to understand and implement current standards of practice is to be immersed in a setting that provides access to a comprehensive curriculum in a real-life setting with hands-on practice mentored by faculty who are truly subject matter experts.
 
The Sterile Compounding Training Center indoctrinates learners to current sterile compounding best practices through presentation of theoretical and practical information presented in e-learning, classroom and realistic workplace simulations. Once registered, attendees are provided with access to selected CriticalPoint e-learning lessons that must be completed prior to the onsite attendance. Once at the class, learners are presented information to assist them to implement cleanroom principles and practices that comply with USP <797> as well as industry best practices. Classes are taught in a state-of-the-art facility designed for cleanroom and pharmacy practice demonstration. Topics covered include cleanroom physical design and layout; engineering controls and airflow science; personnel media fill testing and process validation as well as an exploration of principles associated with workflow, cleaning, environmental sampling, validation, staff training and documentation. Attendees completing this program will gain an understanding of how to develop and implement an operation that meets or exceeds USP Chapter <797> requirements. Participants will take home sample electronic templates for policies, procedures and documentation that can be customized to their facility’s needs.
 
This program is approved for 29 CE credit hours (10 hours E-learning and 19 hours of live training which includes 1 hour of law credit) or 2.9 Continuing Education Units (CEUs) by Educational Review Systems (ERS). ERS is accredited as a provider of continuing pharmacy education by the Accreditation Council for Pharmacy Education (ACPE). Certificates are awarded to all participants who successfully complete all 10 eLearning lessons, attend the entire program and complete the evaluation form.
 

Objectives:

  1. Summarize important events in the history of pharmacy sterile compounding and how these have influenced practice standards, sterile compounding regulation, pharmacy education and training as well as quality management.
  2. Explain current facility, environmental and personnel metrics requirements for compounding sterile preparations in compliance with USP.
  3. Describe how primary and secondary engineering controls contribute to airflow velocity, direction and ultimately ISO classification.
  4. Recognize best practices (as well as worst practices) of aseptic technique in your workplace.
  5. Perform proper hand hygiene, garbing and gloved fingertip sampling.
  6. Describe facility cleaning, material handling and conduct of personnel in controlled sterile compounding environments.
  7. Practice aseptic technique in LAFWs and isolators in a cleanroom environment visualizing first air and gaining an appreciation of how improper technique and material organization can disrupt first air.
  8. Describe documentation of operator and process media fill tests as well as required actions in the event that growth is detected.
  9. Explain how, when and why these tests are performed: HEPA filter leak test, measurement of particle counts, pressure differentials, airflow velocity and smoke pattern testing.
  10. Describe the quality assurance, assignment of BUD and release testing of sterile to sterile CSPs and nonsterile to sterile CSPs.
  11. Develop an Environmental Sampling Plan as well as collect and document viable air and surface samples.
  12. Summarize the key elements to review during the consideration of a cleanroom renovation or construction project.
  13. Discuss key issues, challenges and concerns related to selecting a cleanroom certification company as well as how to read a certification report.