EP1860029A1 - Ensemble de distribution de liquide radioactif pour la préparation de produits radioactifs - Google Patents

Ensemble de distribution de liquide radioactif pour la préparation de produits radioactifs Download PDF

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Publication number
EP1860029A1
EP1860029A1 EP06425346A EP06425346A EP1860029A1 EP 1860029 A1 EP1860029 A1 EP 1860029A1 EP 06425346 A EP06425346 A EP 06425346A EP 06425346 A EP06425346 A EP 06425346A EP 1860029 A1 EP1860029 A1 EP 1860029A1
Authority
EP
European Patent Office
Prior art keywords
flask
dispensing
radiofluid
conveying
tube
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP06425346A
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German (de)
English (en)
Inventor
Paolo Bedeschi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Comecer SpA
Original Assignee
Comecer SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Comecer SpA filed Critical Comecer SpA
Priority to EP06425346A priority Critical patent/EP1860029A1/fr
Publication of EP1860029A1 publication Critical patent/EP1860029A1/fr
Withdrawn legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B3/00Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B3/003Filling medical containers such as ampoules, vials, syringes or the like

Definitions

  • the present invention relates to a radiofluid dispensing assembly for the preparation of radioactive products.
  • the dispensing operation for the preparation of disposable containers (flasks or syringes) of radioactive products is particularly complex and delicate. Indeed, given the variable nature of radioactivity, rapid dispensing is required while maintaining possible errors of concentration within negligible limits. In particular, if a high concentration of radioisotope is present, the possibility of concentration errors is very high.
  • the object of the present invention is to make a dispensing assembly of radioactive products whose technical features ensure a rapid dispensing operation, containing concentration errors within negligible limits also from highly concentrated radioisotope solutions.
  • the object of the present invention is a radiofluid dispensing assembly for the preparation of radioactive products, comprising a tank of physiological solution, a first radioactivity calibrator, a first dispensing flask adapted to receive the synthesised radiofluids and accommodated in said first calibrator, and a first conduit for conveying the physiological solution from the tank to the first dispensing flask; said dispensing assembly being characterised in that it comprises an appropriately shielded deposit flask, a second conduit for conveying radiofluids from said first dispensing flask to said deposit flask and vice versa, a second calibrator adapted to accommodate a finished product container, a third conduit for conveying radiofluids appropriately diluted by the first dispensing flask to the finished product container and a fourth conduit for conveying the physiological solution from the tank to said finished product container, at least one pump for allowing the movement of fluids and a control unit adapted to receive information from the first and second calibrators and to control the displacement of the fluids
  • the assembly according to the present invention comprises a plurality of valves, arranged on said conduits and controlled by the control unit.
  • Assembly 1 comprises a physiological solution tank 2, a first calibrator 3 provided with radioactivity sensors (not shown) and in which a first dispensing flask 4 is accommodated, a deposit flask 5 arranged within a shielding casing, and a second calibrator 7 provided with radioactivity sensors (not shown) and in which the finished product container 9, for example a flask or a syringe, is accommodated.
  • Assembly 1 comprises a physiological solution conveying line 8 adapted to connect physiological solution tank 2 either to first dispensing flask 4 or finished product container 9.
  • the physiological solution conveying line 8 consists of a first tube 10 which extends from physiological solution tank 2 to a first T union schematically shown in the figure, of a second tube 12 which extends from the first T union to first dispensing flask 4 and of a third tube 13 which extends from the first T union to finished product container 9.
  • a first peristaltic pump 11 to displace the physiological solution operates on tube 10.
  • a respective valve 14a and 14b of the "normally closed" type is inserted to select the destination of the physiological solution.
  • Assembly 1 comprises a radiofluid conveying line 15 adapted to reciprocally connect the first dispensing flask 4 either to deposit flask 5 or finished product container 9.
  • the radiofluid conveying line 15 consists of a first tube 16 which extends from the first dispensing flask 4 to a second T union schematically shown in the figure, of a second tube 17 which extends from the second T union to deposit flask 5, and of a third tube 18 which extends from the second T union to finished product container 9.
  • a second peristaltic pump 19 operates on the first tube 16 to displace the diluted and undiluted radiofluids.
  • each of the tubes 17 and 18 a respective valve 20a and 20b of the "normally closed" type is inserted to select the connection of flask 4 to deposit flask 5 and to finished product container 9, respectively.
  • the synthesised radioisotope is introduced into flask 4 through a tube 21 connected to first tube 16.
  • a valve 22 of the "normally closed" type is inserted to isolate radiofluid conveying line 15 from introduction of synthesised radioisotope.
  • the tubes included in the conveying line of physiological solution 8 and in the radiofluid conveying line 15 have an internal volume of 0.05 ml for each 100 mm of length.
  • tubes 13 and 18 are connected to the finished product container 9 by two respective dripping needles known and not shown for the sake of simplicity.
  • Assembly 1 comprises a control unit 23 schematically illustrated in figure and connected to the two calibrators 3 and 7, to peristaltic pumps 11 and 19 and to valves 14a, 14b, 20a, 20b and 22.
  • unit 23 detects the concentration of radioactive activity from the two calibrators and controls the pumps and the valves for conveying the physiological solution and the radiofluids.
  • the operations of control unit 23 may be controlled by an operator by means of an interface or be automatically performed once a set of parameters to be respected are entered in the control unit itself.
  • the first dispensing flask 4 receives the synthesised radioisotope through tube 21 and calibrator 3 measures the activity thereof by transferred volume. Once the activity in the first dispensing flask 4 is measured, the operator decides the quantity to be transferred to the deposit flask 5 by controlling the opening of the valve 20a. At this point, the operator decides the dilution value in the first dispensing flask 4 and controls the appropriate introduction of physiological solution opening the valve 14a. Once the required dilution is reached, the operator orders the transfer of solution from the first dispensing flask 4 to the finished product container 9 by opening valve 20b. Finally, after detecting activity by means of calibrator 7, the exact required dilution is obtained by controlling the introduction of more physiological solution in the finished product container 9 by opening the valve 14b.
  • the time for filling a flask or a syringe with 3 ml of product is approximately 40 seconds.
  • the assembly of the present invention allows to prepare radiopharmaceuticals by dispensing radiofluids in an accurate and fast manner.
  • the assembly of the present invention can withhold high concentrations of radioactivity without however causing dispensing errors such as to compromise the preparation of the radiopharmaceutical.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
EP06425346A 2006-05-23 2006-05-23 Ensemble de distribution de liquide radioactif pour la préparation de produits radioactifs Withdrawn EP1860029A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP06425346A EP1860029A1 (fr) 2006-05-23 2006-05-23 Ensemble de distribution de liquide radioactif pour la préparation de produits radioactifs

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP06425346A EP1860029A1 (fr) 2006-05-23 2006-05-23 Ensemble de distribution de liquide radioactif pour la préparation de produits radioactifs

Publications (1)

Publication Number Publication Date
EP1860029A1 true EP1860029A1 (fr) 2007-11-28

Family

ID=37440658

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06425346A Withdrawn EP1860029A1 (fr) 2006-05-23 2006-05-23 Ensemble de distribution de liquide radioactif pour la préparation de produits radioactifs

Country Status (1)

Country Link
EP (1) EP1860029A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2179926A1 (fr) * 2008-10-23 2010-04-28 Commissariat A L'energie Atomique Dispositif stérile à usage unique de préparation d'un médicament radiopharmaceutique, système et procédé mettant en oeuvre ce dispositif
ITBO20080762A1 (it) * 2008-12-19 2010-06-20 Comecer Spa Macchina per il dosaggio di flaconi con radiofluidi
FR2956091A1 (fr) * 2010-02-11 2011-08-12 Commissariat Energie Atomique Dispositif sterile a usage unique de mise en seringue de medicaments radiopharmaceutiques, systeme semi-automatique et procede de mise en seringues mettant en œuvre ce dispositif
FR2970703A1 (fr) * 2011-01-25 2012-07-27 Commissariat Energie Atomique Dispositif sterile a usage unique de mise en seringues de medicaments radiopharmaceutiques, systeme automatique et procede de mise en seringues mettant en oeuvre ce dispositif
WO2012092564A3 (fr) * 2010-12-30 2012-10-26 Ge Healthcare Limited Distribution à plusieurs flacons
US11851221B2 (en) 2022-04-21 2023-12-26 Curium Us Llc Systems and methods for producing a radioactive drug product using a dispensing unit

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005002971A1 (fr) * 2003-07-02 2005-01-13 Iphase Technologies Pty. Limited Procede et dispositif de distribution de doses d'une solution radioactive
US20050278066A1 (en) * 2004-06-15 2005-12-15 Kevin Graves Automated dispensing system and associated method of use

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005002971A1 (fr) * 2003-07-02 2005-01-13 Iphase Technologies Pty. Limited Procede et dispositif de distribution de doses d'une solution radioactive
US20050278066A1 (en) * 2004-06-15 2005-12-15 Kevin Graves Automated dispensing system and associated method of use

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2179926A1 (fr) * 2008-10-23 2010-04-28 Commissariat A L'energie Atomique Dispositif stérile à usage unique de préparation d'un médicament radiopharmaceutique, système et procédé mettant en oeuvre ce dispositif
FR2937618A1 (fr) * 2008-10-23 2010-04-30 Commissariat Energie Atomique Dispositif sterile a usage unique de preparation d'un medicament radiopharmaceutique, systeme et procede mettant en oeuvre ce dispositif
ITBO20080762A1 (it) * 2008-12-19 2010-06-20 Comecer Spa Macchina per il dosaggio di flaconi con radiofluidi
FR2956091A1 (fr) * 2010-02-11 2011-08-12 Commissariat Energie Atomique Dispositif sterile a usage unique de mise en seringue de medicaments radiopharmaceutiques, systeme semi-automatique et procede de mise en seringues mettant en œuvre ce dispositif
WO2012092564A3 (fr) * 2010-12-30 2012-10-26 Ge Healthcare Limited Distribution à plusieurs flacons
CN103384510A (zh) * 2010-12-30 2013-11-06 通用电气健康护理有限公司 多管瓶分配
US9433556B2 (en) 2010-12-30 2016-09-06 Ge Healthcare Limited Multi-vial dispensing
CN103384510B (zh) * 2010-12-30 2016-10-19 通用电气健康护理有限公司 多管瓶分配
FR2970703A1 (fr) * 2011-01-25 2012-07-27 Commissariat Energie Atomique Dispositif sterile a usage unique de mise en seringues de medicaments radiopharmaceutiques, systeme automatique et procede de mise en seringues mettant en oeuvre ce dispositif
WO2012101074A1 (fr) 2011-01-25 2012-08-02 Commissariat à l'énergie atomique et aux énergies alternatives Dispositif sterile a usage unique de mise en seringues de medicaments radiopharmaceutiques, systeme automatique et procede de mise en seringues mettant en œuvre ce dispositif
US11851221B2 (en) 2022-04-21 2023-12-26 Curium Us Llc Systems and methods for producing a radioactive drug product using a dispensing unit

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