Microbial contamination of syringes during preparation: The direct influence of environmental cleanliness and risk manipulations on end-product quality

PURPOSE: The direct influence of environmental cleanliness and risk manipulations on prepared syringes was evaluated. METHODS: Media-fill testing was used to estimate potential microbial contamination. Syringes were prepared in three different environments using four different uncontrolled high-risk manipulations. The three environments included an International Organization for Standardization (ISO) class 5 horizontal laminar-airflow hood in an ISO class 6 cleanroom (in accordance with United States Pharmacopeia [USP] chapter 797), an ISO class 7 drug preparation area of an operating room, and an uncontrolled decentralized pharmacy in a ward. For each combination of environment and manipulation, 100 syringes were filled by a single operator. The four high-risk manipulations used included simple filling of syringes with trypticase soy broth, three-second contact by the ungloved fingers of the operator with the hub of the syringe, three-second contact between an object and the hub of the syringe, and exposure of the filled syringes to ambient air for 10 minutes. RESULTS: Of the 1500 syringes prepared in three different environments, none produced within the cleanroom contained microorganisms, 6% were contaminated in the operating room, and 16% were contaminated in the ward (p < 0.0001). Certain high-risk manipulations were associated with a significant increase in the contamination of the surrogate syringes, including exposure to nonsterile ambient air and nonsterile objects or fingers (p < 0.0001). CONCLUSION: High contamination rates were measured when the hub of syringes touched nonsterile environmental surfaces and fingers, whereas the drawn-air manipulation was associated with a lower risk of contamination. Working within a properly operating unidirectional airflow primary engineering control in an ISO class 5 cleanroom in accordance with USP chapter 797 requirements was demonstrated to be the best way to avoid bacterial or fungal contamination of injectable drugs directly resulting in patient infections.