Preservative Efficacy Screening of Pharmaceutical Formulations Using ATP Bioluminescence

Abstract

The preservative challenge test is a method used to determine the efficacy of a preservation system in a pharmaceutical or cosmetic formulation. However, such testing is a labor-intensive, repetitive task often requiring days before results can be generated. Several alternatives to traditional colony-count techniques have been developed. A study using pure suspensions of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Bacillus subtilis, Candida albicans, and Aspergillus niger showed that the accuracy, repeatability, and linearity of the Pallchek™ luminometer ATP bioluminescence (ATP-B) system was equivalent to the traditional colony-count method. In any case, the method proved sensitive enough to follow the effect of preservatives on a number of test microorganisms, indicating the applicability of the ATP-B method for preservative screening studies in various pharmaceutical formulations.

Validation of constitutively expressed bioluminescent Pseudomonas aeruginosa as a rapid microbiological quantification tool

“…Accuracy was measured as defined by Parenteral Drug Association (PDA) and International Organisation of Standardisation (ISO) as closeness of the true results obtained by the test method to that of the current method (ISO, 1994a(ISO, , 1994bKramer et al, 2008;Krouse, 2005;PDA, 2000). Precision, defined as the level of agreement between individual test results when the method is applied to samples in replicate, was analysed by determining the bioluminescence and plate count for ten replicates of all serially diluted samples.…”

“…Limit of detection (LOD), defined as the detection of smallest and greatest number of microorganisms in a sample (Kramer et al, 2008;Krouse, 2005;PDA, 2000) was determined by measuring bioluminescence of various concentrations of microorganisms in triplicate. Limit of quantification (LOQ) is defined as the accurate and precise quantification of the least and greatest number of microorganisms in a sample (Krouse, 2005;PDA, 2000).…”

“…Various instruments have been used to detect minute concentrations of microbes in clinical samples, food and water, such as flow cytometry (Perez et al, 1998), impedimetry, chromatography, infrared and fluorescence spectroscopy and bioluminescence (Ivnitski et al, 1999). Adenosine triphosphate (ATP) bioluminescence has also been utilised to determine intracellular levels of ATP in microbial cells (Kramer et al, 2008). The ATP bioluminescence assay is a sensitive assay that requires a few minutes.…”

“…This obviously has an effect on the time of release of products and therefore a cost implication. There is also a requirement for skilled personnel able to operate under the time constraints that the pharmaceutical, food and cosmetics industries currently face (Kramer et al, 2008).…”

Bioluminescent assay of microbial ATP in postmortem tissues for the estimation of postmortem interval

“…The intensity of the emission is proportional to the initial concentration of Qian ATP and the measurements can be made by using luminometer. BLA is widely used in various fields, such as microbiology [4][5][6] , food industry [7][8][9][10] , environmental monitoring [11][12][13][14][15] and mass detection of chemical and pharmaceutical products [16][17][18][19][20] , because of the simplicity and rapidity of the method. But few reports concerning its use in forensic medicine are available.…”