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New Paper on Rapid Sterility Testing

Scientists at Alcon Laboratories have recently published a paper on the use of the Chemunex ScanRDI as a rapid alternative to the pharmacopoeial sterility test. Two sterility test methods, the ScanRDI rapid sterility test and the United States Pharmacopeia/European Pharmacopoeia/Japanese Pharmacopoeia (USP/EP/JP) compendial sterility test, were compared withrespect to the limits of detection for the presence of viable microorganisms in aqueous solutions at low inoculation levels. Eight microorganisms were evaluated, seven compendial microorganisms (Clostridium sporogenes, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Aspergillus niger, Candidaalbicans) and the Gram-positive anaerobe Propionibacterium acnes. The number of viable organisms was estimated using the ScanRDI method and the conventional sterility test method using most probable number methodology. The mean difference between the methods was computed and 95% confidence intervals around the mean difference were estimated. The ScanRDI method was found to be numerically superior and statistically non-inferior to the compendial (USP/EP/JP) sterility test with respect to the limits of detection for all organisms tested.

PDA members may download the article for free from the PDA Journal website. The full reference is provided below. For a comprehensive list of rapid method published papers, please visit our Reference Page.

2010. Smith, R.; Von Tress, M.; Tubb, C.; Vanhaecke, E. Evaluation of the ScanRDI as a Rapid Alternative to the Pharmacopoeial Sterility Test Method: Comparison of the Limits of Detection. PDA Journal of Pharmaceutical Science and Technology. 64(4): 356-363.

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