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A preliminary investigation into the ability of three rapid microbiological methods to detect microorganisms in hospital intravenous pharmaceuticals

Hiom, Sarah, Denyer, Stephen, Talbot, Catherine, Maillard, Jean-Yves, Spark, Paul and Smith, Julian 2013. A preliminary investigation into the ability of three rapid microbiological methods to detect microorganisms in hospital intravenous pharmaceuticals. PDA Journal of Pharmaceutical Science and Technology 67 (4) , pp. 376-386. 10.5731/pdajpst.2013.00928

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Abstract

This study investigated the capability of three rapid microbiological methods to detect microorganisms in aseptically prepared pharmacy preparations at National Health Service hospitals in the United Kingdom. BacT/ALERT 3D (bioMerieux), AKuScreen (Celsis), and BactiFlow ALS (AES Chemunex) technologies were used to detect levels of microorganisms in pharmaceutical products. Four products selected to represent the range of pharmaceuticals prepared in National Health Service hospital pharmacy departments were spiked with known levels of microorganisms. The presence of microorganisms in these products was then determined using each of the rapid microbiological methods and compared to the number determined by traditional total aerobic microbial count methodology. An evaluation of the performance parameters associated with each of the methods, including cost analysis, was also undertaken. There was good correlation between rapid microbiological methods and total aerobic microbial count for heparin and parenteral nutrition products. The rapid microbiological methods had difficulty recovering Gram-positive organisms from vancomycin and methotrexate products; however, protocol developments demonstrated that this was surmountable. The main differences between the rapid microbiological method systems were time-to-result, the initial equipment cost, and the skill required to operate the instruments. The main finding from this work is that rapid microbiological methods can detect microbial contamination of hospital pharmaceutical products in a reduced time when compared to traditional microbiological techniques. The instrument comparison showed that Celsis AKuScreen provided the most rapid result for detecting bacteria; BacT/ALERT was the least expensive instrument and the simplest system to use; and BactiFlow ALS was the most expensive and more complex to use and gave intermediate time to results.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Pharmacy
Subjects: R Medicine > RS Pharmacy and materia medica
Uncontrolled Keywords: BacT/ALERT 3D; AKuScreen; BactiFlow ALS; microbial detection; Aseptic manufacture; quality; rapid.
Publisher: Parenteral Drug Association
ISSN: 1079-7440
Last Modified: 16 Apr 2019 20:19
URI: http://orca.cf.ac.uk/id/eprint/60663

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