title: A preliminary investigation into the ability of three rapid microbiological methods to detect microorganisms in hospital intravenous pharmaceuticals.
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.
  Traditional methods to assure quality and detect any microbial contaminants in intravenous products takes at least 2 weeks to complete. Hospital-prepared intravenous products are often high risk and have short shelf lives. This sometimes means that the traditional quality microbiological results are only available after the product has been administered to the patient. There have been some fatal incidents in which contaminated intravenous products have been used. Rapid microbiological methods have been used in the food, cosmetic, and pharmaceutical industries; however, they have not as yet been used in United Kingdom National Health Service pharmacy manufacturing. Rapid microbiological methods are able to detect contaminants in shortened periods of time. This study investigates the ability of three rapid microbiological methods to detect artificially contaminated, National Health Service-prepared intravenous products and compares the results to those obtained from traditional total aerobic microbial count methodology. The results show that there are differences between the methods; however, generally rapid microbiological methods are able to detect contaminants from pharmacy-prepared intravenous products quicker than current traditional methods.
authors.affiliation: Cardiff & Vale University Health Board, St Mary's Pharmaceutical Unit (SMPU), Llanishen, Cardiff, UK;
authors.forename: Sarah
authors.initials: S
authors.lastname: Hiom
authors.forename: Stephen
authors.initials: S
authors.lastname: Denyer
authors.forename: Catherine
authors.initials: C
authors.lastname: Talbot
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Maillard
authors.forename: Paul
authors.initials: P
authors.lastname: Spark
authors.forename: Julian
authors.initials: J
authors.lastname: Smith
mesh_terms: D001419:Bacteria; D004345:Drug Industry; D006801:Humans; D008828:Microbiological Techniques; D004364:Pharmaceutical Preparations; D010607:Pharmacy Service, Hospital; D006113:United Kingdom
chemical_list: D004364:Pharmaceutical Preparations
keywords: AKuScreen; Aseptic manufacture; BacT/ALERT 3D; BactiFlow ALS; Microbial detection; Quality; Rapid