USP 797 Sterile Compounding: What Pharmacy Techs Must Know
Understand the fundamentals of USP chapter 797 for sterile compounding, including beyond-use dating, cleanroom classifications, and garbing procedures for the PTCE.
What Is USP 797?
USP chapter 797 sets the standards for preparing compounded sterile preparations (CSPs) in pharmacies. Its goal is to prevent patient harm from contamination, incorrect strength, or ingredient degradation. The 2023 revision tightened requirements around beyond-use dating, environmental monitoring, and personnel competency. These changes frequently appear on PTCE practice questions.
Categories of CSPs
Under the revised USP 797, CSPs are categorized based on preparation conditions and assigned beyond-use dates (BUDs) accordingly:
- Category 1 - Prepared in a segregated compounding area (SCA) or under less controlled conditions. Short BUDs apply: 12 hours at room temperature or 24 hours refrigerated.
- Category 2 - Prepared in a cleanroom suite meeting ISO classification requirements with full environmental monitoring. Longer BUDs are permitted based on sterility testing and stability data.
ISO Classifications
The primary engineering control (PEC), such as a laminar airflow workbench or biological safety cabinet, must provide ISO Class 5 air. The buffer area surrounding the PEC must meet ISO Class 7. The ante area must meet ISO Class 8. Each classification indicates the maximum allowable particle count per cubic meter of air.
Garbing Procedures
Proper garbing is essential to prevent contamination. Personnel must don garments in the correct order: shoe covers, hair cover, face mask, hand washing, non-shedding gown, and sterile gloves. Sterile gloves must be applied with an aseptic technique and wiped with sterile 70% isopropyl alcohol before touching any sterile surfaces.
Media Fill Testing
Every person who compounds sterile preparations must pass an initial media fill test and repeat it at least annually. The media fill simulates the compounding process using a growth medium instead of actual drugs. If microbial growth is detected, the compounder must undergo retraining and retesting before preparing CSPs.
Environmental Monitoring
Viable and non-viable air sampling and surface sampling must be performed regularly. Action levels are defined in USP 797. If microbial counts exceed action levels, an investigation and corrective action are required.
Understanding USP 797 is essential for any technician working in sterile compounding and for passing the patient safety domain of the PTCE.
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