Evaluation of microbial contamination associated with different preparation methods for neonatal intravenous fat emulsion infusion.
OBJECTIVE
Microbial contamination associated with different methods of neonatal intravenous fat emulsion (IVFE) preparation and delivery was evaluated.


METHODS
Sterility testing was performed on IVFE dispensed via three different methods: (1) in the original container (n = 60), (2) repackaged into a syringe (n = 90), and (3) drawdown of the original container (n = 60). At the end of each infusion (24 hours for methods 1 and 3, 12 hours for method 2), a sample of the IVFE was withdrawn from the container using a sterile syringe in an International Organization for Standardization class 5 hood and sent to the hospital microbiology laboratory, where the samples were introduced into blood culture bottles and incubated for five days. Each sample was then subcultured on a blood agar plate with olive oil and left for an additional two days in a carbon dioxide incubator to assess for Malassezia furfur.


RESULTS
None of the samples from the original containers showed bacterial or fungal growth. Three of the samples from syringes had bacterial growth (two samples contained coagulase-negative staphylococcus and one contained both Klebsiella oxytoca and Citrobacter freundii), yielding a contamination rate of 3.3%. The number of contaminated samples did not significantly differ among the three preparation methods (p = 0.13).


CONCLUSIONS
Repackaging IVFE into sterile syringes resulted in bacterial contamination and should be avoided in clinical practice. IVFE samples obtained using the drawdown procedure under sterile conditions for infusion over 24 hours revealed no microbial contamination.
Crill
Catherine M
CM
Department of Clinical Pharmacy and Pediatrics, University of Tennessee Health Science Center, Memphis, USA. ccrill@uthsc.edu <ccrill@uthsc.edu>
Hak
Emily B
EB
Robinson
Lawrence A
LA
Helms
Richard A
RA
D001419:Bacteria / Q000302:isolation & purification; D004339:Drug Compounding / Q000379:methods / Q000592:standards*; D004340:Drug Contamination; D004349:Drug Packaging; D004356:Drug Storage; D005217:Fat Emulsions, Intravenous / Q000592:standards*; D006801:Humans; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D010607:Pharmacy Service, Hospital / Q000379:methods*; D013594:Syringes / Q000382:microbiology; D013997:Time Factors
D005217:Fat Emulsions, Intravenous