HEATSEAL

Abstract

The present invention relates to systems and methods to facilitate replacement between runs of a kit or cassette from an automated radiosynthesis device located in a hot cell. The method and apparatus of the invention enable automated disconnection of the outlet line by sealing the tubing hermetically by means of heat and by cutting the tubing where it is sealed in such a way that there is no risk of environmental contamination with radioactive material. The invention enables disconnection of the outlet line without manual intervention before opening the shielded enclosure.

Claims

1. A method comprising: (i) providing a kit that can be fitted to an automated radiosynthesis device in order to synthesise a positron emission tomography (PET) tracer and one or more sections of thermoplastic tubing; (ii) fitting said kit and said one or more sections of thermoplastic tubing to the automated radiosynthesis device; (iii) introducing a PET isotope into said kit to carry out a radiochemical process to form a radiolabelled product; (iv) transferring said radiolabelled product from said kit to a product collection device and/or a product processing device; and, (v) heat sealing and cutting said one or more sections of thermoplastic tubing.

2. The method as defined in claim 1 wherein said product collection device is a product collection vial.

3. The method as defined in claim 2 wherein said product processing device is a chromatography device, a dispensing device or a quality control device.

4. The method as defined in claim 3 wherein each of said radiosynthesis device, product collection device and product processing device is contained within a shielded enclosure.

5. The method as defined in claim 4 wherein said shielded enclosure is a hot cell.

6. The method as defined in claim 5 wherein said automated radiosynthesis device is contained within a first shielded enclosure and said product collection device and/or said product processing device are contained within a second shielded enclosure.

7. The method as defined in claim 5 wherein said automated radiosynthesis device and said product collection device and/or said product processing device are contained within the same shielded enclosure.

8. The method as defined in claim 7 wherein said one or more sections of thermoplastic tubing comprise one or more of: (a) tubing connecting the kit to an enriched .sup.18O water vial; (b) tubing fluidly connecting a reaction vessel within said kit; (c) tubing comprised in a product outlet line; (d) tubing comprised in a product outlet extension line; and, (e) tubing connecting the kit to a waste container.

9. The method as defined in claim 8 wherein said product outlet line is heat sealed in the shielded enclosure containing the radiosynthesis device.

10. The method as defined in claim 9 wherein said product outlet line is extended by means of an extension line.

11. The method as defined in claim 10 wherein said extension line is connected via screw-type connectors.

12. The method as defined in claim 11 wherein said screw-type connectors are Luer connectors.

13. The method as defined in claim 12 wherein said kit comprises said precursor compound contained in a vial.

14. The method as defined in claim 8 wherein said reaction vessel is fluidly connected within said kit by means of one or more reaction vessel lines wherein said reaction vessel lines comprise thermoplastic tubing.

15. The method as defined in claim 14 comprising the additional step carried out either before or after step (v) of heat sealing and then cutting said thermoplastic tubing of said one or more reaction vessel lines.

16. The method as defined in claim 15 wherein said kit is a cassette.

17. The method as defined in claim 16 wherein said heat sealing and cutting is carried out by: (a) placing a portion of said thermoplastic tubing in a press; (b) activating said press to compress said portion of tubing; (c) heating said press to seal said portion of tubing by heat welding; and, (d) cutting said sealed tubing within the portion of tubing sealed by step (c).

18. The method as defined in claim 17 wherein said thermoplastic tubing is made from polypropylene (PP), polyethylene (PE), polyvinyl chloride (PVC), nylon, polytetrafluoroethylene (PTFE) or polyether ketone (PEEK).

19. The method as defined in claim 18 wherein said thermoplastic tubing is made from polypropylene (PP) or polyethylene (PE).

20. The method as defined in claim 19 wherein said PET isotope is .sup.68Ga.

21. The method as defined in claim 19 wherein said PET isotope is .sup.11C.

22. The method as defined in claim 19 wherein said PET isotope is .sup.18F.

23. The method as defined in claim 22 wherein, prior to said transferring step (iv), one or more of the following steps is carried out on said radiolabelled product: (a) removing any protecting groups where these are present; (b) removing excess PET isotope; (c) removing one or more impurities from said radiolabelled product.

24. The method as defined in claim 23 which comprises the subsequent steps of: (vi) removing said kit from said automated radiosynthesis device; and then, (vii) disposing of said kit into a shielded waste container.

25. An apparatus comprising: (i) an automated radiosynthesis device; (ii) a kit that can be fitted to an automated radio synthesis device in order to synthesise a PET tracer; (iii) one or more sections of thermoplastic tubing; (iv) a heat sealing and cutting device located proximal to said one or more sections of thermoplastic tubing.

26. The apparatus as defined in claim 25 wherein said one or more sections of thermoplastic tubing comprise one or more of: (a) tubing connecting the kit to an enriched .sup.18O water vial; (b) tubing fluidly connecting a reaction vessel within said kit; (c) tubing comprised in a product outlet line; and, (d) tubing connecting the kit to a waste container.

27. The apparatus as defined in claim 26 wherein said product outlet line is extended by means of an extension line.

28. The apparatus as defined in claim 27 wherein said extension line is connected via screw-type connectors.

29. The apparatus as defined in claim 28 wherein said screw-type connectors are Luer connectors.

30. The apparatus as defined in claim 29 wherein said kit comprises a precursor compound contained in a vial.

31. The apparatus as defined in claim 26 wherein said tubing fluidly connecting said reaction vessel comprises one or more reaction vessel lines.

32. The apparatus as defined in claim 31 wherein said kit is a cassette.

33. The apparatus as defined in claim 32 wherein said thermoplastic tubing is made from polypropylene (PP), polyethylene (PE), polyvinyl chloride (PVC), nylon, polytetrafluoroethylene (PTFE) or polyether ketone (PEEK).

34. The apparatus defined in claim 33 wherein said thermoplastic tubing is made from polypropylene (PP) or polyethylene (PE).

Description

BRIEF DESCRIPTION OF THE FIGURES

[0062] FIG. 1 shows an example of a commercially-available automated radiosynthesis device showing the product outlet line.

[0063] FIGS. 2 and 3 show examples of a heat sealing arrangements suitable for use in the present invention.