Apparatus and Method for Automated Quality Control

A method for an automated quality control analysis of a PET tracer comprising determining a measurement value for each of the following quality control parameters:

• particle and color content;
• filter membrane integrity;
• radionuclidic purity;
• radioactive concentration;
• pH of the sample solution;
• Kryptofix concentration;
• radiochemical identity;
• radiochemical purity;
• specific activity of the sample;
• bacterial endotoxin concentration;
• residual solvent concentration;
• comparing each measurement value of the quality control parameters with a predetermined corresponding criterion value;
• determining a cumulative quality rating for the radiopharmaceutical agent;
• and
• releasing a report validating the sample based on the said quality rating.

An apparatus for automated quality control analysis of a PET tracer comprising the following elements:

• an injection valve configured to deliver the sample from a vial via a syringe in to the sample line;
• at least one sample line filled with the sample for a plurality of quality control tests;
• a distribution valve;
• a filter membrane integrity test setup;
• an optical cell for color and/or appearance test connected to a light source and/or a laser and a spectrometer via fiber optics;
• a HPLC column;
• a UV cell connected to a UV light source and a UV detector via fiber optics;
• a radioactivity detection modules;
• a GC column;
• a pH test cell,
• one or more ports to operatively couple the elements to a computer system for quantitative processing of the experimental data and generation of a report reflecting the quality of the sample against the predetermined standards.

A quality control system comprising:

• an apparatus for automated quality control analysis of a sample;
• and
• a synthesis module for originating the sample,
• wherein the apparatus comprises the following elements:
• an introduction module configured to deliver the sample from a vial;
• at least one sample line filled with the sample for a plurality of quality control tests;
• a distribution valve;
• a filter membrane integrity test setup;
• an optical cell for color and/or appearance test connected to a light source and/or a laser and a spectrometer via fiber optics;
• a HPLC column;
• a UV cell connected to a UV light source and a UV detector via fiber optics;
• a radioactivity detection module;
• a GC column;
• a pH test cell;
• one or more ports to operatively couple the elements to a computer system for quantitative processing of the experimental data and generation of a report reflecting the quality of the sample against the predetermined standards.