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Bacterial contamination of solutions for parenteral administration for single- and multiple-dose vials after multiple
Elisabeth Nogler-Semenitz1, Cornelia Lass-Flörl, Michael Nogler
1Hospital Pharmacy, University Hospital Innsbruck, Innsbruck, Austria. Elisabeth.Nogler-Semenitz@tilak.at
Abstract:
Outbreaks traced to bacterial contamination of multiple-dose vials are reported in the literature. During a four-month period, multi-dose vials (MDVs), single-dose vials (SDVs), and vials containing self-prepared admixtures were collected from various wards to analyse sterility of their contents. We examined 68 commercially available MDVs containing sodium chloride 0.9% or heparin with added preservative and 17 single dose vials (SDVs) containing aqua ad injectionem or sodium chloride 0.9% and 11 vials with admixtures (ADX) of heparin and sodium chloride 0.9%, both without preservative. Four of 96 (4.17%) vials were not sterile: two of them were contaminated with spore-forming bacteria, two with coagulase negative Staphylococci. Three of the samples were MDVs containing a preservative. The date of the first use was not marked on 28% of the vials. Twenty-eight samples were multiply used, although they were SDVs or ADXs without preservative or without an adequate amount of preservative, respectively. In 15 of 68 MDVs, the time limit after the first use was exceeded. On average, the volume of the samples was 80% of the original volume. A proportion of 4% of vials was not sterile. A training programme for health care workers in aseptic techniques and for validation of the preparation of solutions for parenteral use should be installed.
Insights
Bacterial contamination in vials, including multi-dose vials (MDVs), poses a risk. A study found 4.17% of vials were non-sterile, highlighting the need for improved aseptic techniques in healthcare settings.
Area of Science:
- Microbiology
- Healthcare Quality & Safety
- Pharmaceutical Sciences
Background:
- Bacterial contamination of medication vials, particularly multi-dose vials (MDVs), has been linked to outbreaks.
- Ensuring the sterility of injectable medications is critical for patient safety.
Purpose of the Study:
- To assess the sterility of multi-dose vials (MDVs), single-dose vials (SDVs), and self-prepared admixtures (ADX) in a clinical setting.
- To identify potential breaches in aseptic technique and vial handling practices.
Main Methods:
- Sterility testing was performed on 96 vials: 68 MDVs, 17 SDVs, and 11 ADXs.
- Vials contained sodium chloride 0.9%, heparin, or admixtures, with or without preservatives.
- Data on vial usage, labeling, and time since first use were recorded.
Main Results:
- 4.17% (4/96) of the examined vials were non-sterile, with contamination by spore-forming bacteria and coagulase-negative Staphylococci.
- Three non-sterile samples were MDVs that contained preservatives.
- 28% of vials lacked the date of first use; 28 samples were used beyond recommended limits or without adequate preservative.
Conclusions:
- A significant proportion of vials, including those with preservatives, were found to be non-sterile.
- Improper handling, such as exceeding usage limits and inadequate labeling, contributes to contamination risks.
- Implementation of training programs for aseptic techniques and validation of parenteral solution preparation is recommended.
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