Abstract
A practical procedure for sterility testing of intravenous admixtures contained in plastic bags using membrane filtration was developed. This technique was then evaluated in a pilot study involving 140 (18 percent) of the large volume intravenous admixtures prepared during June, 1972, by a central pharmacy admixture program. The technique was effective in detecting all of the positive controls, intentionally contaminated, in the pilot study.
The pilot study furnished the necessary data to statistically determine a monthly sample size of intravenous admixtures to be cultured, which would represent the entire population at a 95 percent confidence level with a 5 percent allowable error of the mean, and to implement a program of routine sterility monitoring by the hospital's Epidemiology Department.
Procedures involved in maintaining sterility in a centralized intravenous admixture program were also implemented and are discussed.
Results of this study indicate that a program of routine sterility monitoring of a hospital pharmacy intravenous admixture program can be implemented simply and practically. The program would monitor potential contamination from both the pharmacy and pharmaceutical manufacturers.
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