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Microbial Limit Testing Technology Overview

Microbial Limit Testing Technology Overview. Advisory Committee for Pharmaceutical Science July 19, 2001. Compendial Methods USP. Plate Counts- Colony Forming Units Growth of microorganisms on solid medium Count visible colonies MPN- Most Probable Number

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Microbial Limit Testing Technology Overview

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  1. Microbial Limit TestingTechnology Overview Advisory Committee for Pharmaceutical Science July 19, 2001

  2. Compendial MethodsUSP • Plate Counts- Colony Forming Units • Growth of microorganisms on solid medium • Count visible colonies • MPN- Most Probable Number • Multiple serial dilutions of sample • Based on statistical distribution of organisms in a sample ACPS

  3. ADVANTAGES Simple Counts only viable organisms DISADVANTAGES Incubation time (48-72 hours) Not all organisms will grow on a single medium Compendial Methods ACPS

  4. Microbial Viability • Only interested in viable microorganisms • “New” methods must only count viable organisms • Viability indicators needed ACPS

  5. Esterase DetectionChemScan®, Chemunex • Enzyme ubiquitous in microorganisms • Chem-Chrome, a non-fluorescent fluorescein derivative cleaved by esterase to fluorescein ACPS

  6. ChemScan® Procedure • Filter Sample • Expose membrane to reagent • Membrane analyzed by laser-scanning ACPS

  7. ATP BioluminescenceMicroStar(TM) & MicroCount(TM), Millipore • ATP- Primary energy source for all organisms • Luciferin/luciferase (reagent) reacts with ATP to produce light ACPS

  8. MicroStar(TM) Procedure • Filter Sample • Place membrane on solid medium for brief incubation • Disrupt cells to release ATP • Add bioluminescence reagent to membrane • Detect light with CCD and computer analysis ACPS

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