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Quality of intravenous infusion fluids manufactured in Kenya
J A Aluoch-Orwa1, C O Ondari, I O Kibwage
1University of Nairobi, Faculty of Pharmacy.
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.
Insights
Microbial contamination and chemical failures were found in Kenyan intravenous fluids. Older manufacturing sites demonstrated better product quality, indicating experience is key to reducing intravenous fluid contamination.
Area of Science:
- Microbiology
- Pharmaceutical Science
- Public Health
Background:
- Intravenous (IV) fluids are critical for patient care.
- Ensuring the sterility and chemical integrity of IV fluids is paramount to prevent healthcare-associated infections and adverse events.
- Previous assessments of IV fluid quality in Kenya indicated variability.
Purpose of the Study:
- To evaluate the microbial contamination and chemical composition of intravenous fluids from four manufacturing establishments in Kenya.
- To identify the types of microbial contaminants present and assess failure rates related to chemical quality.
- To explore the correlation between manufacturing site experience and product quality.
Main Methods:
- Sterility testing of IV fluids using the European Pharmacopoeia membrane filtration method.
- Microbial identification of isolated contaminants, including Aspergillus, Candida, and Staphylococcus.
- Chemical analysis to determine failure rates related to product composition.
Main Results:
- Significant microbial contamination was detected, with failure rates ranging from 10.5% to 28.6% across the four sources.
- Aspergillus was the predominant contaminant, followed by Candida and Staphylococcus.
- High failure rates due to chemical composition were observed, particularly for sources A (66.7%) and D (60.0%).
- Older manufacturing establishments exhibited lower contamination and chemical failure rates, suggesting a correlation with experience.
Conclusions:
- The study highlights significant quality control issues in Kenyan IV fluid manufacturing, posing risks to patient safety.
- Experience in manufacturing appears to be a critical factor in ensuring the quality and safety of intravenous fluids.
- Recommendations for improved manufacturing practices and regulatory oversight are warranted to enhance IV fluid quality in Kenya.