90 MIN vs. 14 DAYS
Results from the conventional compendial sterility test, those approved under the USP or the Ph. Eur. 2.6.1, are mostly released after a 14-day duration. Due to the short shelf-life of some cell products, the sterility test results are released only after the cell therapy product has been administered to the patients. However, our combination of epifluorescence Raman micro-spectroscopy (GRAM RAY) and the adaptable analyzing software allows a breakthrough of 90 MIN sterility tests. Its results could mitigate the risks and ensure the quality of the products before administering them to the patients.
mibic offers validation toolbox, demonstrating the GRAM RAY’s equal or even greater assurance of the test methodology against the compendial method. Our testing methodology complies with the specifications from the USP and the Ph. Eur. 2.6.27. In addition, we provide adequate information on test robustness, specificity and sensitivity.
GRAM RAY’s aseptic sample preparation system handles sample volumes between 0.1 – 200 ml and is fully automated. It performs all handling steps including the centrifugation.
90 M TIME TO RESULT
It takes only 90 MIN time including isolation and 30 mind incubation for GRAM RAY to provide viable microbes (bacteria, yeast, and fungi) enumeration and species identification.
Ensured by a two steps viability measurement only viable microbes are detected and counted by the system. Even viable slow growing or weak bacteria, yeast, and fungi are detected and differentiated from dead microbes.
LIMIT OF DETECTION
A single viable microbe is detected by GRAM RAY. The product-specific sampling procedure ensures high recovery rates.
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