Abstract
The effect of sterilization temperature and sterilization efficacy (F0) on the amount of 5-hydroxymethyl-2-furaldehyde (5-HMF) and glucose, number of particles generated and color of Ringers/glucose infusion solution is described. The infusion solution was a 5% glucose solution containing Ringer-type electrolytes. The solutions were autoclaved in a pilot scale autoclave using different temperature/time combinations to produce the target F0 values of 10, 15, 20 and 25 minutes. The amounts of 5-HMF and glucose were determined by HPLC. The use of the shortest possible sterilization cycle to yield the target F0 resulted in the lowest 5-HMF concentrations in the Ringers/glucose infusion solutions studied. The spectrochromatograms of the sterilized solutions showed that glucose is degraded into various degradation products in the presence of Ringer-type electrolytes. It was also demonstrated by SEM/EDX that a significant part of the particles result from the leaching of the silicon oil used in the manufacture of rubber stoppers for LVP solutions. The number of particles generated in different solutions and the particle size distributions were determined with a Coulter-Counter. The particle size distributions show no clear correlation between sterilization process conditions and the number of particles. The results show that it is possible to minimize the amount of 5-HMF generated even when the same F0 is used, by choosing the highest sterilization temperature possible. This also leads in practice to the shorter sterilization processes, saving both process time and energy.
- Received September 30, 1991.
- Accepted May 20, 1992.
- Copyright © Parenteral Drug Association. All rights reserved.
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