Clinical Microbiology Procedures Handbook

Section 15: Epidemiologic and Infection Control Microbiology

15.3 Microbiological Sampling for Pharmacies that Compound Sterile Preparations

Last Updated:2023

Over 100 years have passed since the 1906 Pure Food and Drug Act led to the creation of the U.S. Food and Drug Administration (FDA), which established the United States Pharmacopeia (USP) as the official standard for drugs in…

15.3.1 Environmental Monitoring by Viable Air Sampling

The environmental monitoring (EM) program is designed to determine whether the primary engineering controls (PECs) are maintaining an environment within the compounding area of the pharmacy that consistently ensures…

15.3.2 Surface Sampling

Although the CDC has long advised against surface sampling in hospitals, the United States Pharmacopeia (USP) has made surface sampling of primary and secondary engineering controls a requirement…

15.3.3 Gloved Fingertip Testing

The easiest way to contaminate compounded sterile preparations is by direct contact with contaminated gloves. Gloved fingertip testing is designed to evaluate whether pharmacy personnel are washing their hands and donning garb with care…

15.3.4 Media Fill Test Procedure

This procedure checks the aseptic technique of individuals performing low‐, medium‐, and high‐risk sterile compounding. Two individuals must be involved: the operator/compounder, who is performing the procedure…

15.3.5 USP <71> Sterility Testing

The sterility test is performed on compounded sterile preparations (CSPs) to ensure that a product is free of microbial contaminants and safe for patients to use. A specific number of containers of the product and a specific…

15.3.6 Endotoxin Testing

Pharmaceutical products compounded from nonsterile components requiring end‐product sterilization, and products classified by United States Pharmacopeia (USP) as high risk, must be tested for the presence of endotoxin…


Section Editor: J. Kristie Johnson

Editors in Chief: Amy L. Leber and Carey-Ann D. Burnham

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