Effect of laminar air flow and clean-room dress on contamination rates of intravenous admixtures.
The effect of laminar air flow conditions and clean-room dress on the microbial contamination rates of intravenous admixtures was investigated. Intravenous admixtures were prepared by one investigator using aseptic technique under four environmental conditions: laminar air flow conditions with clean-room dress; laminar air flow without clean-room dress; clean table top with clean-room dress; and clean table top without clean-room dress. In each environmental condition, 350 admixtures were compounded. Negative-control samples (n = 150) were also tested, as were 10 positive-control samples. Samples were tested in each of two growth media and incubated at 35 degrees C for 14 days or until growth occurred. The incidence of contamination of admixtures compounded in laminar air flow conditions was significantly less than the contamination of those compounded on a clean table top (p less than 0.05) regardless of the operator's dress. The incidence of contamination of admixtures compounded while wearing clean-room dress was not significantly different from those prepared while not wearing clean-room dress regardless of the environment in which the admixture was prepared. The overall low level of contamination [0.79% (11/1400)] was inconclusive regarding the effect of dress on the incidence of contamination when admixtures were prepared under LAF conditions. It is concluded that, when one adheres to aseptic technique, the environment in which admixtures are compounded is the most important variable affecting the microbial contamination rate.
D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination / Q000517:prevention & control*; D005069:Evaluation Studies as Topic; D007263:Infusions, Parenteral; D011481:Protective Clothing; D012996:Solutions; D014691:Ventilation
D012996:Solutions