Method of operating an automated radiopharmaceutical synthesizer

Patent metadata

Field	Value
Publication number	US-10029228-B2
Application number	US-201214348690-A
Country	US
Kind code	B2
Filing date	Sep 24, 2012
Priority date	Sep 30, 2011
Publication date	Jul 24, 2018
Grant date	Jul 24, 2018

Abstract

The present invention relates to calibration and normalization systems and methods for ensuring the quality of radiopharmaceuticals during the synthesis thereof, such as radiopharmaceuticals used in Positron Emission Tomography (PET) and Single-Photon Emission Computed Tomography (SPECT).

First claim

What is claimed is:

1. A method of monitoring a radiopharmaceutical synthesis process, comprising:
configuring a radiopharmaceutical synthesizer and conducting a first radiopharmaceutical synthesis process and to generate a first set of data including at least a) a first activity measurement obtained at a first time point in the first radiopharmaceutical synthesis process by at least one of a first radioactivity detector or a first sensor and b) a second activity measurement obtained at a second time point in the first radiopharmaceutical synthesis process by at least one of a second radioactivity detector or a second sensor, wherein i) the at least one of a first radioactivity detector or a first sensor and ii) the at least one of a second radioactivity detector or a second sensor are located at different components in the radiopharmaceutical synthesizer;
generating, based on the first set of data, a diagnostic fingerprint indicating activity measured with respect to time for a successful synthesis process execution;
conducting a second radiopharmaceutical synthesis process to generate a second set of data;
comparing the second set of data to the diagnostic fingerprint to evaluate the second radiopharmaceutical synthesis process by at least:
processing the first set of data and the second set of data to generate a first extracted data and a second extracted data, respectively, wherein processing the first set of data further includes applying a first correlation factor to the first set of data to normalize the first set of data and wherein processing the second set of data further includes applying a second correlation factor to the second set of data to normalize the second set of data; and
determining deviation of the second extracted data from the first extracted data to assess performance of the second radiopharmaceutical synthesis process; and

when the deviation indicates a correction for the second radiopharmaceutical synthesis process, adjusting a subsequent radiopharmaceutical synthesis process by at least:
determining a third correlation factor based on the determined deviation of the second extracted data from the first extracted data, the third correlation factor forming a correction factor; and
implementing the correction factor to adjust the subsequent radiopharmaceutical synthesis according to the diagnostic fingerprint of the first radiopharmaceutical synthesis process.

2. The method of claim 1 , further comprising:
configuring the radiopharmaceutical synthesizers to transmit the first set of data and the second set of data electronically.

3. The method of claim 1 , further comprising:
configuring a plurality of radioactivity detectors located in the radiopharmaceutical synthesizer for providing the radioactivity detector measurements.

4. The method of claim 1 , wherein the first set of data comprises a data collection file.

5. The method of claim 1 , wherein the first set of data comprises data points measured and recorded at a predefined interval during the first radiopharmaceutical synthesis process.

6. The method of claim 1 , further comprising:
configuring the radiopharmaceutical synthesizer to automatically implement the correction factor.

7. The method of claim 1 , wherein the radiopharmaceutical synthesizer is configured to produce a radiopharmaceutical.

Assignees

• Ge Healthcare Ltd

Inventors

• Engell Torgrim
• Grigg Julian
• Gausemel Ingvil
• Dyrstad Knut
• Shales Jonathan R

Classifications

• G21G1/0005

  Isotope delivery systems (use of radioisotopes as tracers G21H5/02) · CPC title

• B01J19/0046 Primary

  Sequential or parallel reactions, e.g. for the synthesis of polypeptides or polynucleotides; Apparatus and devices for combinatorial chemistry or for making molecular arrays (synthesis methods per se C40B50/00) · CPC title

• G16H40/40

  for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades · CPC title