Quality of intravenous infusion fluids manufactured in Kenya.

ABSTRACT

The incidence and nature of microbial contamination of intravenous fluids prepared by four manufacturing establishments in Kenya was evaluated using the European Pharmacopoeia membrane filtration method for sterility testing. The percentage failures were 28.6% for source D, 18.8% for source A, 12.5% for source B and 10.5% for source C. The major contaminant was aspergillus which was isolated from samples from three sources. Candida and Staphylococcus accounted for the contamination of samples from two sources. Failure rates due to the chemical composition of the products was 66.7% for Source A, 60.0% for D, 41.7% for C and 13.3% for B. The experience of the manufacturing sites appeared to correlate with the quality of the products, with the older manufacturing establishments showing lower percentage failures.