Learning Objectives
By the end of this lesson, pharmacists and technicians will be able to:
- Explain the purpose of surface sampling and its role in environmental monitoring and contamination control.
- Identify the types of media used in contact plates (e.g., Tryptic Soy Agar, Sabouraud Dextrose Agar, and neutralizers) and their functions.
- Describe USP <797> requirements for the frequency, timing, and locations of surface sampling in classified cleanroom areas.
- Demonstrate the correct technique for collecting a surface sample using contact plates.
- Outline the proper labeling, transport, and incubation conditions for collected plates, including the two-stage incubation method.
- Interpret action levels for ISO 5, ISO 7, and ISO 8 areas, and recognize when results require investigation.
- Apply corrective and preventive actions (CAPA) when surface sampling results exceed action levels.
- Document sampling results accurately, including site, date, operator, media lot, incubation, and final counts.
- Perform post-sampling cleaning of surfaces to restore aseptic conditions.
- Summarize the role of surface sampling in maintaining patient safety and compliance with USP standards.
Lesson Content
