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Particulate and microbial contamination in in-use admixed parenteral nutrition solutions
1Department of Pharmacy, Yamaguchi University Hospital, 1-1-1 Minamikogushi, Ube 755-8505, Japan.
Abstract:
We evaluated particulate and microbial contamination in a total of 192 samples of in-use admixed and unadmixed parenteral nutrition solutions remaining in infusion bags in 10 hospitals. The mean numbers (range) of drug glass ampoules, plastic ampoules, and vials used in a total of 192 admixed solutions were 3.38 (1-13), 0.79 (0-7), and 1.2 (0-8), respectively. The mean number of particles (range) contained in the 192 samples according to the particle size (diameter) was 960.9 (30-9,539)/ml for particles >or=1.3 microm, 42.8 (0-587)/ml for those >or=5 microm, 6.4 (0-146)/ml for those >or=10 microm, and 0.09 (0-1)/ml for those >or=50 microm. The number of particles >or=1.3 microm in diameter was significantly higher in the 192 samples than in 7 samples (controls) of solutions not mixed with any ampoule or vial (p<0.0001). In addition, the number of particles >or=1.3 microm in diameter was significantly higher in samples of solutions mixed with 4-13 glass ampoules than in those of solutions mixed with 1-3 glass ampoules (p<0.01). On the other hand, none of the 199 samples showed bacteria or fungi/5 ml residual solution. Measures against particulate contamination of admixed parenteral nutrition solutions are necessary.
Insights
Particulate contamination is a significant issue in parenteral nutrition solutions, with higher particle counts found in solutions mixed with more glass ampoules. Microbial contamination was not detected.
Area of Science:
- Pharmaceutical Science
- Clinical Pharmacy
- Healthcare Quality
Background:
- Parenteral nutrition (PN) solutions are critical for patients unable to receive nutrition orally.
- Admixing multiple drugs into PN solutions can potentially introduce contaminants.
- Assessing contamination in in-use PN solutions is vital for patient safety.
Purpose of the Study:
- To evaluate the levels of particulate and microbial contamination in in-use parenteral nutrition solutions.
- To identify potential sources or contributing factors to contamination in admixed PN solutions.
Main Methods:
- Analysis of 192 samples of in-use PN solutions from 10 hospitals.
- Quantification of particulate contamination based on particle size (≥1.3, ≥5, ≥10, ≥50 micrometers).
- Microbial testing for bacteria and fungi in residual solutions.
Main Results:
- Significantly higher particulate contamination (≥1.3 micrometers) was observed in PN solutions compared to controls.
- Increased particulate load correlated with the number of glass ampoules used in admixing.
- No bacterial or fungal contamination was detected in any of the tested samples.
Conclusions:
- Particulate contamination is a prevalent issue in in-use admixed PN solutions.
- The number of glass ampoules used in admixture is a significant factor contributing to particulate contamination.
- Implementing measures to mitigate particulate contamination in PN solutions is essential.
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