Patent ID: 8214159
Filing Date: 2012-07-03
Classification: G01N

Abstract:
1. A method for an integrated automated quality control analysis of a radioactive tracer compound comprising the following steps: utilizing a single sample injection, the single sample injection being a sample having a particular volume, for a plurality of inline quality control tests being conducted in a single pass; determining a sterility result via a filter membrane integrity test, the filter membrane integrity test being performed without use of the single sample injection and the sterility result being used to confirm filter membrane integrity; conducting a quantitative analysis of the single sample injection via the plurality of quality control tests; determining a measurement value of each of the plurality of quality control parameters; comparing each measurement value of the plurality of quality control parameters with a predetermined corresponding criterion value; determining a cumulative quality rating for the single sample injection based on the plurality of quality control tests and membrane integrity test; generating a quantitative report, that reflects a quantified result of the quality of the single sample injection against predetermined standards for the single sample injection, the report being based on the cumulative quality rating for the single sample injection; and releasing the quantitative report validating the single sample injection based on the quality rating, wherein the single sample injection is used for every control test required for the sample.