Rapid Scan RDI Microbial Detection Test (filterable samples only). Rapid microbiological test with direct cell count, down to a single microbial cell, without the need for cell growth. Procedure utilizes fluorescent labeling and laser scanning technologies for the detection of bacteria, mold, yeast, and fungi. Results usually available within 48 hours after receipt of sample. (Method independently verified to USP standards – references upon request.)
The Chemunex Scan RDI™ is a state-of-the-art instrument that allows microbial cell counts in one to two business days. It combines speed with sensitivity to allow direct counts of bacteria, molds, and fungi down to one colony-forming unit. Eagle Analytical Services is very proud to have this exclusive piece of equipment in their laboratory. There are less than 40 Scan RDIs in the United States. Some of the biggest pharmaceutical companies received their local authority approval for the use of the sterility test using the Scan RDI.
The Scan RDI is an automated system that directly distinguishes individual cells without requiring a time-consuming growth stage. It utilizes a four-step protocol. The first step is membrane filtration through a 25mm membrane. The second step includes cell labeling with a fluorescent dye. During the third step, the membrane is placed in the Scan RDI instrument and is scanned with a laser. Within three minutes, all viable microorganisms are detected and counted. The fourth step is visual confirmation of the microorganisms with a fluorescent microscope.
The Scan RDI does have its limits. Only aqueous samples can be filtered through the 25mm membrane. On the other hand, the speed of the test allows the compounding pharmacist to know in a few days, rather than fourteen (14) days, if their samples are grossly contaminated. This allows remedial action to be taken immediately, without waiting for a USP <71> sterility test.
Eagle Analytical Services only permits degreed personnel properly trained in microbiology to perform the procedures for the Scan RDI. Sample preparation is performed in our certified Class 100 biological safety cabinet, located in our certified Class 100 clean room. The Scan RDI test procedure is a very exacting procedure, where asepsis of the procedure must be ensured for a correct interpretation of the results.
For more information on ScanRDI technology and its suitability for the Eagle Sterility Test, see our white paper click here.
For USP <71> Sterility Test details, please call 1.800.745.8916