PHM 227 Pharmacy Lab 2

Lecture Hours: 2
Lab Hours: 3
Credits: 3

Expands upon the foundational skills developed in Pharmacy Laboratory I by introducing sterile and hazardous compounding, aseptic technique, and quality assurance principles. Students learn to operate within USP 797 and 800 standards, perform sterile product preparation, and follow contamination control and documentation procedures required in institutional and hospital pharmacy settings.

Maximum number of credits course can be taken for: 3

Student Learning Outcomes:

Describe the principles of aseptic technique and sterility as outlined in USP 797. (ASHP 3.15-3.17, 4.2)
Identify requirements for the safe handling of hazardous drugs following USP 800 and OSHA standards. (ASHP 3.11, 5.1-5.5)
Perform sterile compounding procedures including garbing, hand hygiene, and manipulation within a laminar airflow workbench. (ASHP 3.15-3.17)
Explain environmental monitoring, cleaning, and maintenance processes for sterile environments. (ASHP 4.1, 4.3, 5.4)
Apply quality assurance and documentation procedures to ensure product accuracy and regulatory compliance. (ASHP 3.13, 4.5, 5.5)
Demonstrate professional conduct and effective teamwork during laboratory activities. (ASHP 1.1-1.8)

Content Outline

Introduction to Sterile Compounding Standards
- Overview of USP <797> and <800>
- Principles of sterility, contamination, and infection control
Aseptic Technique and Workflow
- Hand hygiene, garbing, and PPE
- Cleanroom and laminar airflow hood operation
- Sterile product assembly and manipulation
Hazardous Drug Handling and Safety
- Hazardous containment and PPE requirements
- Engineering controls and biological safety cabinets
- Waste disposal and spill management procedures
Quality Assurance and Environmental Monitoring
- Cleaning and disinfection schedules
- Airflow certification and particulate monitoring
- Equipment calibration and documentation
Documentation and Regulatory Compliance
- Sterile compounding records and batch logs
- Labeling, verification, and BUD assignment
- Audit and inspection readiness
Professionalism and Collaboration
- Team communication in sterile environments
- Ethical conduct and precision in aseptic work