A New Rapid Microbiology Method based on Measuring Oxygen Depletion: An Assay for Testing Surfaces of Equipment, Facilities, and Personnel in Pharmaceutical Manufacturing Controlled Environments
Claudio Denoya, Ph.D., a Senior Applications Scientist, Life Sciences Division at Particle Measuring Systems, is presenting at the upcoming Europe conference on pharmaceutical microbiology. His current main focus is in Environmental Monitoring to control and improve aseptic processes in the pharmaceutical and related industries. Dr. Denoya has authored more than 80 patents, book chapters, and journal articles and presented more than 200 technical presentations at international scientific meetings.
His presentation will cover the detection, enumeration and identification of microbial contaminants found in drug products and the manufacturing environment. Despite a surge on the number of rapid microbiological methods now available in the market, the use of traditional methodology such as the growth of microorganisms in liquid broth or on agar plates is quite widespread. These methods typically require lengthy incubation times. With the current need to cut costs and increase profit margins, there has been an enhanced need for rapid methods that can improve handling capacity, reduce time delays, and assist in overall optimization of quality control operations.
This study evaluates the feasibility of using an oxygen depletion-based method as a rapid microbiology assay to test raw materials, excipients, drug products, and environmental monitoring applications in the pharmaceutical industry. The system detects microbial contamination based on measurements of oxygen depletion upon time of incubation in a pharmacopoeia recommended liquid broth, such as TSB. The results of this study show that this rapid microbiology technology is reliable, sensitive, and equivalent to standard compendia tests. Validation parameters evaluated according to guidance references show that the limit of detection for this assay is similar to the LOD obtained with the traditional methods. When a sample is contaminated with just one or less than five microbial cells the Time to Result (TTR) with this system is reduced to 24 hours or less, leading to much faster microbiological evaluation of pharmaceutical samples when compared to the traditional methodology. Moreover, the TTR is inversely proportional to the number of microorganisms initially present in the sample. Linearity was observed in a broad range of microorganism concentrations (1 x100 to 1 x 105) and linear regression analysis showed in all cases square of the correlation coefficient (r2) values ≥ to 0.95. In addition, results were automatically read eliminating human reading subjectivity, and showing a high degree of precision. Thus, we conclude that the rapid microbial method presented here represents a valid alternative application for the microbial monitoring of surface pharmaceutical samples. Validation results using a variety of pharmaceutical reference and representative bacterial, yeast and mold cultures as well as results from a surface monitoring application will be discussed.
Date & Time: Tuesday, 23 February 2016, 16:00h
Session 3: Future Trends: Testing
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