Method for multi-batch production of FDG

• US 20040022696A1
• Filed: 04/23/2003
• Published: 02/05/2004
• Est. Priority Date: 05/12/2000
• Status: Active Grant

• Current Assignee: Siemens Medical Solutions USA Incorporated (Siemens AG)
• Original Assignee: CTI Incorporated (Siemens AG)
• Inventors: Matteo, Joseph C., Zigler, Steven S., Mangner, Thomas
• Granted Patent: US 7,718,436 B2
• Time in Patent Office: Days
• US Class Current: 422/159
• CPC Class Codes: G01N 35/1002 Reagent dispensers
• CPC Class Codes: G01N 35/1079 with means for piercing stoppers or septums
• CPC Class Codes: Y10T 436/25625 Dilution
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A method of producing multiple batches of a radiopharmaceutical, such as FDG. The method includes the steps of transferring the appropriate liquids to a production apparatus, processing the liquids to produce the radiopharmaceutical, delivering the radiopharmaceutical to a container, automatically cleaning the apparatus, and repeating the previous steps, as desired. The apparatus for multi-batch production of FDG includes a reagent delivery system, a reaction vessel, a filter assembly, and a control system. The combination of these components provides a method that is capable of producing multiple batches of a radiopharmaceutical with minimal operator intervention and, consequently, minimal radiation exposure.

Claims

1. A method for producing multiple batches of a radiopharmaceutical such as fluorodeoxyglucose, said method comprising the steps of:

(a) manually providing at least one reagent to an apparatus for automatically producing a plurality of batches of a radiopharmaceutical, said apparatus having an accelerator, a target chamber, and a reaction vessel;

(b) transferring said at least one reagent to said apparatus;

(c) processing said at least one reagent wherein said radiopharmaceutical is produced;

(d) delivering said radiopharmaceutical to a container;

(e) cleaning said apparatus, whereby said apparatus is in a condition for preparing another batch of the radiopharmaceutical; and

(f) repeating steps (b) though (e) to produce a selected number of said plurality of batches of said radiopharmaceutical.

2. The method of claim 1 further including a step of initiating production after said step of manually providing said at least one reagent, wherein said step of transferring, said step of processing, and said step of delivering are performed automatically and sequentially upon said step of initiation.

3. The method of claim 2 wherein said step of cleaning is performed automatically after said step of delivering.

4. The method of claim 1 wherein said step of cleaning includes the steps of:

(a) transferring a solvent to said apparatus;

(b) automatically routing said solvent through said apparatus; and

(c) exhausting said solvent from said apparatus.

5. The method of claim 1 wherein said step of processing includes the steps of:

transferring said at least one reagent to said accelerator;

transferring said at least one reagent to said target chamber; and

transferring said at least one reagent to said reaction vessel.

6. The method of claim 1 wherein said step of processing includes the steps of:

transferring said at least one reagent to said accelerator;

transferring said at least one reagent from said accelerator to said target chamber; and

transferring said at least one reagent from said target chamber to said reaction vessel.

7. The method of claim 1 further including the step of filtering said radiopharmaceutical after said step of automatically processing.

8. The method of claim 7 further including the step of pressure integrity testing of a filter assembly after said step of cleaning said apparatus.

9. The method of claim 8 wherein said step of pressure integrity testing includes the steps of:

a) pressurizing a downstream side of a first filter with a gas supply at a specified pressure;

b) isolating said gas supply from said first filter;

c) monitoring a first filter gas pressure on said downstream side of said first filter for a specified time;

d) venting said first filter gas pressure;

e) rejecting said first filter if monitored said first filter gas pressure is not substantially equal to said specified pressure;

f) pressurizing an upstream side of a second filter with said gas supply at said specified pressure, said second filter downstream of said first filter;

g) isolating said gas supply from said second filter;

h) monitoring a second filter gas pressure on said upstream side of said second filter for a specified time;

i) venting said second filter gas pressure; and

j) rejecting said second filter if monitored said second filter gas pressure is not substantially equal to said specified pressure.

10. A method for producing multiple batches of a radiopharmaceutical such as fluorodeoxyglucose, said method comprising the steps of:

(a) manually providing at least one reagent to an apparatus for automatically producing a plurality of batches of a radiopharmaceutical, said apparatus having an accelerator, a target chamber, a reaction vessel, and a filter assembly;

(b) automatically transferring said at least one reagent to said apparatus;

(c) automatically processing said at least one reagent through said accelerator, said target chamber, and said reaction vessel wherein a radiopharmaceutical is produced;

(d) filtering said radiopharmaceutical;

(e) delivering said radiopharmaceutical to a container;

(f) cleaning said apparatus, whereby said apparatus is in a condition for preparing another batch of said radiopharmaceutical;

(g) pressure integrity testing said filter assembly; and

(h) repeating steps (b) though (g).

11. The method of claim 10 wherein said step of filtering is performed automatically after said step of automatically processing.

12. The method of claim 10 wherein said step of delivering is performed automatically after said step of filtering.

13. The method of claim 10 wherein said step of cleaning is performed automatically after said step of delivering.

14. The method of claim 10 wherein said step of pressure integrity testing is performed automatically after said step of cleaning.

15. The method of claim 10 wherein said step of filtering, said step of delivering, and said step of cleaning are performed automatically and sequentially after said step of automatically processing.

16. The method of claim 10 wherein said step of filtering, said step of delivering, said step of cleaning, and said step of pressure integrity testing are performed automatically and sequentially after said step of automatically processing.