Assessment of potential particulate contamination in intravenous solutions in an adult intensive care unit: a targeted correlation analysis.

Abstract

Background: Intravenous drug administration is essential in intensive care treatment. However, the risk of particulate contamination in infusion solutions during treatment is often underestimated.

Methods: Residual amounts of infusion solutions prepared and administered at the adult intensive care unit were examined for visible and subvisible particles according to the recommendations of the European Pharmacopoeia monographs 2.9.19 and 2.9.20.

Results: Samples from 169 infusion solutions were collected, 149 of which could be analysed. The Pharmacopoeia requirements for visible particles were not fulfilled in 42.9% (n=64/149) of the samples, while the requirements for subvisible particles were not met in 4.7% (n=7/149). A specific correlation between the pharmaceutical drugs or within the infusion set (bottle vs connected infusion line) and particulate contamination was not possible as the sample was too small for a correlation analysis. A Spearman rho analysis showed no correlation between particle contamination and administration mode (subvisible (10 µm): p=0.969, r=-0.005; subvisible (25 µm): p=0.834, r=-0.026; visible: p=0.711, r=-0.047) and particle contamination and dosage form (subvisible (10 µm): p=0.291, r=-0.092; subvisible (25 µm): p=0.513, r=0.057; visible: p=0.415, r=0.071).

Conclusions: This study showed that residuals of intravenously administered solutions have particulate contaminations. A specific causal factor was not identified.