title: 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.
authors.affiliation: Quality Assurance, Lek Pharmaceuticals d.d., Ljubljana, Slovenia. mateja.kramer @siol.net
authors.forename: Mateja
authors.initials: M
authors.lastname: Kramer
authors.forename: Helena
authors.initials: H
authors.lastname: Suklje-Debeljak
authors.forename: Vojko
authors.initials: V
authors.lastname: Kmetec
mesh_terms: D000255:Adenosine Triphosphate / Q000032:analysis*; D001234:Aspergillus niger; D001412:Bacillus subtilis; D002176:Candida albicans; D004340:Drug Contamination; D004926:Escherichia coli; D008163:Luminescent Measurements; D008828:Microbiological Techniques / Q000379:methods*; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011310:Preservatives, Pharmaceutical / Q000032:analysis*; D011550:Pseudomonas aeruginosa; D013211:Staphylococcus aureus; D013242:Sterilization
chemical_list: D004364:Pharmaceutical Preparations; D011310:Preservatives, Pharmaceutical; D000255:Adenosine Triphosphate