Pharmacy Cleanrooms and Sterile Compounding Standards
CRX 101 introduces the fundamental principles and practices governing controlled environments used in sterile compounding. This technician-level course explores the intricate relationship between facility design, operational protocols, and patient safety, focusing on international and national standards. Topics include a detailed examination of particle classification systems for cleanrooms, the environmental controls specified by compounding guidelines, and the critical role of differential pressure in preventing contamination. Learners will delve into the intricacies of proper personnel garbing, aseptic technique fundamentals, and the physics of unidirectional airflow within primary and secondary engineering controls. Through a combination of theoretical instruction and practical exercises, students will develop the foundational understanding required to operate effectively within these highly regulated environments, ensuring compliance and minimizing risks associated with sterile preparations.
InstructorJacob CalhounCourse outline
Lectures, virtual labs, and graded assignments — completed in your browser.
Syllabus
["Week 1: Lesson 1: Introduction to Controlled Environments and Sterile Compounding","Week 2: Lesson 2: International Cleanroom Classification Standards (ISO 14644 Series)","Week 3: Lesson 3: Core Concepts of Sterile Compounding Environment Standards","Week 4: Hands-on Lab: Understanding Cleanroom Particle Counting and Classification","Week 5: Lesson 5: Environmental Monitoring: Methods and Interpretation","Week 6: Lesson 6: Principles of Unidirectional Airflow and Engineering Controls","Week 7: Lesson 7: Pressure Differentials and Airflow Cascades in Cleanrooms","Week 8: Hands-on Lab: Gowning and Aseptic Technique Essentials","Week 9: Lesson 9: Cleaning, Disinfection, and Environmental Control Procedures","Week 10: Lesson 10: Personnel Garbing Requirements and Aseptic Practices","Week 11: Hands-on Lab: Primary Engineering Control Operation and Certification Principles","Week 12: Lesson 12: Material Transfer, Workflow, and Contamination Control","Week 13: Lesson 13: Introduction to Hazard Communication and Waste Management","Week 14: Capstone Service Project: Cleanroom Design and Operational Planning"]