Heatseal

Patent metadata

Field	Value
Publication number	US-10532115-B2
Application number	US-201515117847-A
Country	US
Kind code	B2
Filing date	Mar 30, 2015
Priority date	Mar 28, 2014
Publication date	Jan 14, 2020
Grant date	Jan 14, 2020

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.

First claim

The invention claimed is:

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, wherein a shielded enclosure contains the radiosynthesis device;
(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, wherein the heat sealing and cutting said one or more sections of thermoplastic tubing takes place within the shielded enclosure containing the radiosynthesis device.

2. The method as defined in claim 1 wherein the radiolabeled product is transferred from said kit to the product collection device in step (iv), and said product collection device is a product collection vial.

3. The method as defined in claim 1 wherein the radiolabeled product is transferred from said kit to the product processing device in step (iv), and said product processing device is a chromatography device, a dispensing device or a quality control device.

4. The method as defined in claim 1 wherein each of said radiosynthesis device, and product collection device and/or 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 18 O 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; or,
(e) tubing connecting the kit to a waste container.

9. The method as defined in claim 8 wherein said one or more sections of thermoplastic tubing comprise (c) tubing comprised in a product outlet line, and 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 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).

16. The method as defined in claim 15 wherein said thermoplastic tubing is made from polypropylene (PP), polyethylene (PE), polyvinyl chloride (PVC), nylon, polytetrafluoroethylene (PTFE) or polyether ketone (PEEK).

17. The method as defined in claim 16 wherein said thermoplastic tubing is made from polypropylene (PP) or polyethylene (PE).

18. The method as defined in claim 17 wherein said PET isotope is 68 Ga.

19. The method as defined in claim 17 wherein said PET isotope is 11 C.

20. The method as defined in claim 17 wherein said PET isotope is 18 F.

21. The method as defined in claim 20 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.

22. The method as defined in claim 21 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.

23. An apparatus comprising:
(i) an automated radiosynthesis device, wherein a shielded enclosure contains the 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, wherein the heat sealing and cutting said one or more sections of thermoplastic tubing takes place within the shielded enclosure containing the radiosynthesis device.

24. The apparatus as defined in claim 23 wherein said one or more sections of thermoplastic tubing comprise one or more of:
(a) tubing connecting the kit to an enriched 18 O 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.

25. The apparatus as defined in claim 24 wherein said one or more sections of thermoplastic tubing comprise (c) tubing comprised in a product outlet line, and said product outlet line is extended by means of an extension line.

26. The apparatus as defined in claim 25 wherein said extension line is connected via screw-type connectors.

27. The apparatus as defined in claim 26 wherein said screw-type connectors are Luer connectors.

28. The apparatus as defined in claim 27 wherein said kit comprises a precursor compound contained in a vial.

29. The apparatus as defined in claim 24 wherein said tubing fluidly connecting said reaction vessel comprises one or more reaction vessel lines.

30. The method as defined in claim 29 wherein said thermoplastic tubing is made from polypropylene (PP), polyethylene (PE), polyvinyl chloride (PVC), nylon, polytetrafluoroethylene (PTFE) or polyether ketone (PEEK).

31. The apparatus defined in claim 30 wherein said thermoplastic tubing is made from polypropylene (PP) or polyethylene (PE).

Assignees

• Ge Healthcare Ltd

Inventors

• Mosdzianowski Christoph
• Dumont Philippe
• Kuci Sali

Classifications

• B65B5/04

  Packaging single articles · CPC title

• C07B2200/05

  Isotopically modified compounds, e.g. labelled · CPC title

• B29L2023/00

  Tubular articles (B29L2024/00 takes precedence {; catheters B29L2031/7542}) · CPC title

• A61K51/1286 Primary

  Ampoules, glass carriers carrying the therapeutic or in vivo diagnostic agent · CPC title

• B01J19/004

  Multifunctional apparatus for automatic manufacturing of various chemical products (sequential reactions B01J19/0046) · CPC title