PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Regular Articles
Study of Adaptability and Precision on Rapid Microbe Detection System
Yoshio MONJI
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2000 Volume 2 Issue 1 Pages 40-46

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Abstract
  Detection method of microorganisms which has long been used, is one by counting the unit of colonies formed through naked eye or low magnified scope. On the other hand, there has been developed several rapid detection of microorganisms based on requirements various fields. Those developed methods including bioluminescence method are listed as impedance one, fluorescence one and fluorescence-laser scan one, etc. These methods are useful for specified market, but there has some issues to be resolved, for instance, necessity of increase sensitivity, elimination of false positive incidence and making brief sample preparation. This study was performed to establish a new rapid detection of microorganisms combined with specially modified membrane filter, gene engineering bioluminescence reagent and ultra low light detection equipment. This system: RMDS accord with end user's requirements that are rapid detection and elimination of false positive possibility and easy sample preparation. RMDS method was validated to produce reliability through the control of several elements, factors and so could produce quantitative function also. The test of high purity water by RMDS method has shown good recovery to conventional MF method with rapidity of microorganisms detection. Judging from evaluation results, this system is found to be applicable for monitoring process water and also monitoring of microorganism in the air and from solid surface.
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© 2000 Parenteral Drug Association Japan Chapter
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