1 / 8

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

elpida
Télécharger la présentation

Microbial Limit Testing Technology Overview

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related