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STERILISIERBARER RADIONUKLIDGENERATOR UND VERFAHREN ZU SEINER STERILISIERUNG - Dokument EP0646273
 
PatentDe  


Dokumentenidentifikation EP0646273 21.08.1997
EP-Veröffentlichungsnummer 0646273
Titel STERILISIERBARER RADIONUKLIDGENERATOR UND VERFAHREN ZU SEINER STERILISIERUNG
Anmelder E.I. du Pont de Nemours & Co., Wilmington, Del., US
Erfinder EVERS, John, Henry, Medway, MA 02053, US
Vertreter derzeit kein Vertreter bestellt
DE-Aktenzeichen 69126893
Vertragsstaaten AT, BE, CH, DE, DK, ES, FR, GB, GR, IT, LI, LU, NL, SE
Sprache des Dokument En
EP-Anmeldetag 09.10.1991
EP-Aktenzeichen 929022838
WO-Anmeldetag 09.10.1991
PCT-Aktenzeichen US9107221
WO-Veröffentlichungsnummer 9207365
WO-Veröffentlichungsdatum 30.04.1992
EP-Offenlegungsdatum 05.04.1995
EP date of grant 16.07.1997
Veröffentlichungstag im Patentblatt 21.08.1997
IPC-Hauptklasse G21G 1/00
IPC-Nebenklasse G21H 5/00   

Beschreibung[en]

The present invention relates to a sterilizable radionuclide generator and to a method for sterilizing the same.

United States Patent 3,576,998 (Deutsch et al.) and United States Patent 3,774,035 (Litt) relate to the generation of daughter radionuclide from a relatively longer lived parent radionuclide. The radionuclide generator disclosed in each of these patents comprises a column containing a relatively long lived parent radionuclide. The long lived parent radionuclide is spontaneously decayable into a short lived daughter radionuclide. The column includes an inlet port and an outlet port that are respectively accessible through appropriate respective inlet and outlet connection means.

In use, the short lived daughter radionuclide is selectively removable from the column by passing an eluant liquid through the column. A container of eluant liquid is mounted to the inlet connection means while a receptacle, typically an evacuated vial, for receiving the resulting eluate is directly mounted to the outlet connection means. As the eluant passes through the column daughter radionuclide is drawn into the collection vial.

The manufacture of the radionuclide generator is performed under controlled conditions. The column outlet includes a bacterial retentive filter to assure the sterility of the generator eluate.

Such a radionuclide generator with a removable inlet plug and with a removable outlet cap is described in US-A-3 920 995. The outlet means comprise a filter which is located in the outlet line and serves to insure that the eluate coming from the generator will be sterile and particle free. The filter is provided upstream from the outlet of the needle so that a part of the outlet needle is located downstream of the filter. Therefore, the outer part of the needle is susceptible to contamination from outside. After sterilization of the used generator, the filter does not protect the outside part of the needle against contamination.

It is an object of invention to provide a radionuclide generator with an improved sterility.

This object is achieved, according to the invention, with the features of claim 1 or 7.

The present invention relates to a radionuclide generator of the type having a column having a long lived parent radionuclide and a relatively short lived daughter radionuclide therein. The column has an inlet port and an outlet port with means provided for connecting the inlet port of the column to a source of eluant and means provided for connecting the outlet port of the column to an eluate collection vessel.

In accordance with the present invention a plug is removably mounted to the inlet connecting means to seal the same while a cover is removably mounted to the outlet connecting means. The cover has a vent therein. The vent in the cover permits gases produced during the sterilization of the generator to be vented therethrough. Moreover, the column medium serves as a trap to prevent the escape of the parent radionuclide from the column. A separate, self-sealing inlet tube may be connected to the inlet of the column for loading a parent radionuclide during charging of the column. In addition, a vent needle for venting the source of eluant when the same is connected to the inlet needle may also be provided.

In accordance with the method of the present invention, if the separate self-sealing inlet tube (and vent needle) is (are) provided, the inlet connection means of the column (and vent needle) is (are) sealed by the plug and the column is charged with a parent radionuclide. Charging is effected by connecting the separate inlet tube to a source of parent radionuclide having a predetermined pressure therein while the outlet port of the column is connected to a region having a lower pressure therein. Alternatively, if the separate inlet tube is not provided, charging is effected by connecting the inlet connection means of the column to the source of parent radionuclide and by connecting the outlet port of the column to the lower pressure region.

Once charged, if not previously plugged, the inlet connection means of the column (and vent needle) is (are) sealed by the plug. In addition, the vented cover is disposed over the outlet connection means. The generator is then sterilized, as by the passing of saturated steam under pressure through the fluid pathways within the generator. Gases produced during sterilization are vented through the cover. Venting prevents radionuclide contamination during the sterilization process and allows the sterilization to be the final step of the generator manufacturing process. Therefore no additional manipulations are performed following sterilization which could potentially compromise the sterility of the generator. A bacterial retentive vent filter disposed in the cover prevents microbial ingress and maintains sterility.

The invention will be more fully understood from the following detailed description thereof, taken in connection with the accompanying drawings, which form a part of this application and in which:

  • Figure 1 is a side elevational view of a radionuclide generator in accordance with the present invention with portions thereof shown in section;
  • Figure 2 is a side elevational view, in section, illustrating a cover for the outlet connection means of the radionuclide generator of Figure 1;
  • Figure 3 is a diagrammatic view of the interconnection of a radionuclide generator of Figure 1 with a source of a parent radionuclide and a lower pressure region while the generator is being charged with a parent radionuclide; and
  • Figure 4 is a side elevational view, in section, of a radionuclide generator as shown in Figure 1 mounted in a cannister.

Throughout the following detailed description similar reference numerals refer to similar elements in all Figures of the drawings.

Figure 1 illustrates a radionuclide generator generally indicated by the reference character 10 in accordance with the present invention. The radionuclide generator 10 includes a column 12 surrounded by a cylindrical lead shield 14C. Disposed above the shield 12 is a frustoconical lead shielding plug 14P. The outline of the shield 14C and the plug 14P is indicated in Figure 1 by dashed lines. The details of the structure and operation of the column 12 are fully disclosed in both United States Patent 3,576,998 (Deutsch et al.) and United States Patent 3,774,035 (Litt).

The column 12 is similar to that disclosed in the above-mentioned United States Patent 3,774,035 (Litt), and thus needs to be only briefly discussed. The column 12 is formed of a cylindrical glass housing 12H. The housing is made liquid-tight by the provision of end plugs 12P1 and 12P2. The end plugs 12Pi and 12P2 are typically formed of an elastomeric material, such as silicone. In the preferred instance the end plug 12P1 has a pair of passages 12B1 and 12B2 extending therethrough. The passages 12B1 and 12B2 each open into a relatively enlarged region that defines the inlet port 12I of the column 12. The end plug 12P2 has a passage 12B3 extending therethrough. The passage 12B3 opens into a relatively enlarged region that defines the outlet port 12E of the column. Immediately adjacent to each of the plugs 12P1 and 12P2 is a layer of polyethylene frit 12F. Disposed on a substrate 12S mounted within the housing 12H of the column 12 is a parent radionuclide. The parent radionuclide is spontaneously decayable into a relatively short lived daughter radionuclide.

A support platform 16 having a central reinforcement 16R extending thereunder is secured at a large peripheral flange 16L and at a small peripheral flange 16S to the shielding plug 14P. The platform 16 is preferably molded from polycarbonate plastic material.

Inlet connection means 18 is provided for connecting the inlet port 12I of the column 12 to a source of eluant (not shown). In the preferred instance the inlet connection means 18 comprises an inlet flow line 18F and an associated inlet needle 18N with which it is in fluid communication. The inlet flow line 18F and the inlet needle 18N are typically fabricated from stainless steel tubing. The inlet flow line 18F extends through the plug 14P and the passage 12B1 in the plug 12P1 to its point of communication with the inlet port 12I of the column 12. The inlet needle 18N projects from the support platform 16.

A flow vent needle 20 is mounted on the support platform 16 in the vicinity of the inlet needle 18N. The flow vent needle 20 communicates with a cap 22 that depends from the undersurface of the platform 16. The cap 22 has a vent 22V formed therein.

Means 26 is provided for connecting the outlet port 12E of the column 12 to an eluate connection vessel (also not shown). The outlet connection means 26 includes an outlet flow line 26F (similar to the flow line 18F) and an outlet needle 26N. Both the outlet flow line 26F and the outlet needle 26N are fabricated from stainless steel tubing. The outlet needle 26N projects from the support platform 16. The outlet flow line 26F extends through the plug 14P, the cylindrical shield 14C and the passage 12B3 to the outlet port 12E of the column 12.

A filter arrangement generally indicated by the character 28 may be disposed in the outlet flow line 26F. The filter 28 includes a bacterial retentive filter element (itself not illustrated) that is housed within a polypropylene outer housing 28H. The housing is suggested in full outline. Suitable for use as the filter element is a 0.22 micrometer porous polytetrafluoroethylene (PTFE) membrane that is obtained from Millipore Corporation, Bedford, Massachusetts.

One side of the filter housing 28H is connected to the outlet flow line 26F by a molded silicone connector 29A (shown in section). The opposite side of the housing 28H is connected to the outlet needle 26N by a molded polypropylene hub 29B (shown in section) that extends through the platform 16.

It should be understood that although the inlet connection means 18 and the outlet connection means 26 have been shown as terminating in a needle 18N and 26N, respectively any other form of convenient arrangement whereby the inlet and outlet ports of the column 12 are respectively connected to a source of eluant and to an eluate collection vessel lies within the contemplation of the present invention. For example, needle receiving fittings may be used to terminate the inlet and/or outlet connection means.

In the preferred instance means generally indicated by the reference character 30 connected to the inlet of the column, the means typically being in the form of a charging flow line 30F preferably fabricated from stainless steel, extends through the shielding plug 14P. The charging flow line 30F extends through the passage 12B2 in the end plug 12P1 to its point of communication with the inlet port 12I of the column 12. The charging flow line 30F is thus separate and isolated from fluid communication with the inlet flow line 18F. The means 30 includes a connector fitting 32 terminating the free end of the charging flow line 30F. The fitting 32 is provided with a polycarbonate adapter 32A having a self-sealing pierceable membrane 32M. A suitable adapter is available from Medex Incorporated, Hilliard Ohio, as model B1492. The fitting 32 is connected to the line 30F by a molded silicone inlet connector 32C.

In accordance with the present invention the generator 10 is provided with a plug 36 that is removably mounted to the inlet needle 18N of the inlet connection means 18. When so mounted the plug 36 serves to seal the inlet connection means 18 and thus to prevent fluid flow through the inlet port 12I of the column 12. Moreover, since in the preferred case the flow vent needle 20 is located proximate to the inlet needle 18N, the plug 36 also serves to seal the flow vent needle 20. The plug 36 preferably takes the form of a cylindrical member extruded from an elastomeric material, such as silicone.

Further in accordance with the present ir invention a cover 38 is removably mounted to the outlet connecting means. The structure of the cover 38 is shown in inore detail in Figure 2. The cover 38 includes a generally hollow body member 38B formed from a molded polypropylene plastic material. The lower end of the body member 38B is affixed to a stopper sleeve 38S. The sleeve is closed by a pierceable membrane 38M. The sleeve 38S is formed from an elastomeric material, such as silicone. A suitable sleeve is available from West Company, Phoenixville, PA as model 15. The upper end of the body member 38B receives a cap 38C having a vent 38V therein. The cap 38C is fabricated from polypropylene and has an integral grid 38G that supports a 0.45 micrometer glass matrix bacterial retentive filter 38F thereon. A suitable cap is available from Burron Medical Incorporated, Bethlehem, PA as model S5002300. The vented cap 22 is similar to the vented cap 38 shown in Figure 2.

Having described the structure of the generator 10 in accordance with the present invention the operation thereof may now be discussed. Reference is invited to Figure 3, which is a diagrammatic view of the interconnection of a radionuclide generator 10 as shown in Figure 1 with a source of a parent radionuclide and a lower pressure region while the generator 10 is being charged with a parent radionuclide.

During loading of the radionuclide into the column 12 (and during the subsequent sterilization of the generator 10, as will be discussed) the inlet connection means 18 (specifically, the inlet needle 18N) and the vent flow needle 20 are sealed by the presence of the plug 36 thereon. A needle N coupled to an in-process loading line Lin is inserted through the self-sealing pierceable membrane 32M of the connector fitting 32. The line Lin communicates with a source of parent radionuclide, the same being indicated only diagrammatically by the reference character S. The source S is under a first predetermined pressure, typically atmospheric pressure.

The outlet connection means 26 (specifically, the outlet needle 26N) is inserted into a self-sealing pierceable membrane M of a vacuum line connector C and thus placed in fluid communication with a vacuum line Lvac. The line Lvac communicates with a region shown diagrammatically by the reference character R having a pressure less than the pressure within the parent source S.

With the generator 10 connected to the source S and to the evacuated region R via the line Lin and the line Lvac, respectively, and with the inlet needle 18N and the flow vent 20 sealed by the plug 36, parent radionuclide is drawn through the separate inlet flow line 30F into the column 12. In practice the column 12 of an individual generator or the column 12 in each of a plurality (e. g., on the order of one hundred or more) generators may be charged at one time.

As an alternative, if the separate charging flow line 30F is not provided, the column 12 may be charged using the inlet connection means 18, viz., the inlet needle 18N and its associated the inlet flow line 18F. Once charging is completed, the plug 36 is affixed to the needle 18N and the vent needle 20 (Figure 1).

However charging is accomplished, once the column is charging the vacuum line Lvac is removed from the outlet needle 26N and the cover 38 inserted thereon. Since the plug 36 is also in place the entire fluid path of the generator 10 may then be sterilized. Any suitable sterilization technique may be used, such as the application of saturated steam under pressure through the entire fluid path of the generator 10. The entire fluid path of the generator 10 includes the outlet connection means 26, the inlet connection means 18, the separate charging line 30F (if provided), and the column 12 itself.

Although the inlet port 121 of the column 12 is closed to the atmosphere by the self-sealing membrane 32M of the fitting 32 and by the plug 36 over the inlet needle 18N, the outlet port 12E of the column 12 is nevertheless open to atmosphere through the vent 38V of the outlet needle cover 38.

The hereinabove described structural arrangement of the generator 10 in accordance with the present invention, utilizing as it does the removable inlet plug 36 on the inlet connection means 18 and the vented outlet cover 38 on the outlet connection means 26, allows venting of the generator fluid path through the outlet cover 38. Venting of the fluid path permits the exchange of gases developed within the fluid path by the sterilizing medium (saturated steam) during the sterilization process. Further, the arrangement of the sealed inlet means and the vented outlet means directs the flow of gases and entrained particles developed within the generator fluid path during sterilization through the column 12. The column medium selectively traps residual parent radionuclide, preventing the escape of the same from the generator during sterilization, and thus, preventing any subsequent contamination of the external surfaces of the generator and surroundings.

It may be appreciated that utilizing a generator 10 having the structure in accordance with the present invention sterilization may be the final step of the generator manufacturing process in which the ports 12I, 12E of the column 12 are accessed. Therefore, no additional manipulations need be performed following sterilization which could potentially compromise the sterility of the generator 10. The bacterial retentive filter 38F, disposed in the outlet cover prevents microbial ingress and thus maintains sterility of the generator 10.

With reference now to Figure 4, following sterilization the radionuclide generator 10 is inserted into a cannister 42. The cannister 42 includes a spacer 44 that supports a shielding lead base 46. The base 46 has a recess 48 shaped in correspondence with the outer configuration of the generator 10 and a portion of the plug 14P. A lid 52 having a charge well 54 and a collection well 56 formed therein is secured onto the open upper end of the cannister 42. The inlet needle 18N and the vent flow needle 20 (each still sealed by the plug 36) project into the charge well 54 through an aperture 54A provided therein. Similarly, the outlet needle 26N (itself still covered by the cover 38) projects into the collection well 56 through an aperture 56A provided therein. A dust cover 58 is secured to the cannister 42. A carrying strap 60 may also be provided.

Prior to generating and collecting the radionuclide eluate from the sterilized generator by a user, the dust cover 58 is detached, and the cap 36 and the vented outlet needle cover 38 are removed. The generation and collection of a radionuclide eluate is thereafter effected as described fully in the hereinabove incorporated United States Patent 3,774,035.


Anspruch[de]
  1. Radionuklidgenerator (10) mit
    • einer Säule (12), die ein langlebiges Ausgangs-Radionuklid und ein relativ kurzlebiges Folge-Radionuklid enthält,
    • wobei die Säule (12) einen Einlaß-Port (12I) und einen Auslaß-Port (12E), eine Einrichtung (18) zum Verbinden des Einlaß-Ports (12I) der Säule (12) mit einer Eluant-Quelle und eine Einrichtung (12B3,26F,26N) zum Verbinden des Auslaß-Ports (12E) mit einem Eluat-Sammelbehälter aufweist,
    • einem Stopfen (36), der abnehmbar an der Einlaßverbindungseinrichtung (18) angeordnet ist, um diese zu verschließen,
    • einer abnehmbar an der Auslaßverbindungseinrichtung (26N) angeordneten Abdeckung (38C), und
    • einem stromabwärts von dem Auslaß-Port (12E) angeordneten Filter (38F),
    dadurch gekennzeichnet,
    • daß die Abdeckung (38C) einen Entlastungsauslaß (38V) aufweist und das Filter (38F) stromabwärts von der Auslaßverbindungseinrichtung (12B3,26F,26N) in dem Entlastungsauslaß (38V) angeordnet ist,
    • wodurch während der Sterilisierung des Generators (10) erzeugte Gase durch die Abdeckung (38C) entlüftet werden.
  2. Radionuklidgenerator nach Anspruch 1, gekennzeichnet durch eine Fülleinrichtung (12B2,30F,32), die mit dem Einlaß-Port (12I) der Säule (12) verbunden ist, um die Säule (12) mit einem Ausgangs-Radionuklid zu beschicken, wobei die Fülleinrichtung (12B2,30F,32) von der Einlaßverbindungseinrichtung (18) getrennt ist.
  3. Radionuklidgenerator nach Anspruch 2, dadurch gekennzeichnet, daß die Fülleinrichtung (12B2,30F,32) eine Füllströmungsleitung (30F) aufweist, die mit dem Einlaß-Port (12I) der Säule (12) verbunden ist.
  4. Radionuklidgenerator nach einem der Ansprüche 1-3, gekennzeichnet durch ein Strömungsentlastungsauslaß (20,22) zum Entlasten der Eluant-Quelle, wenn diese mit der Einlaßverbindungseinrichtung (18N,18F,12B1) verbunden ist, wobei der Stopfen (36) ferner abnehmbar mit dem Strömungsentlastungsauslaß (20,22) verbunden ist, um diese zu verschließen.
  5. Radionuklidgenerator nach Anspruch 4, dadurch gekennzeichnet, daß der Strömungsentlastungsauslaß (20,22) eine Ventilnadel (20) aufweist, um die Eluant-Quelle zu entlasten, wenn diese mit der Einlaßnadel (18N) verbunden ist.
  6. Radionuklidgenerator nach einem der Ansprüche 1-5, dadurch gekennzeichnet, daß die Einlaßverbindungseinrichtung (18) eine in einer Einlaßnadel (18N) endende Einlaßströmungsleitung (18F) aufweist, um den Einlaß-Port (12I) mit einer Eluant-Quelle zu verbinden, und die Auslaßeinrichtung (12B3,26F,26N) eine in einer Auslaßnadel (26N) endende Auslaßströmungsleitung (26F) aufweist, um den Auslaß-Port (12E) mit einem Eluat-Sammelbehälter zu verbinden.
  7. Verfahren zum Herstellen eines Radionuklidgenerators (10) des Typs mit einer Säule (12), die einen Einlaß-Port (12I) und einen Auslaß-Port (12E) aufweist, wobei der Einlaß-Port (12I) eine Einlaßverbindungseinrichtung (18) aufweist und der Auslaß-Port (12E) eine Auslaßverbindungseinrichtung (26F,26N) aufweist, mit den folgenden Schritten:
    • (a) Verstopfen der Einlaßverbindungseinrichtung (18) mit einem abnehmbaren Stopfen (36), um diese zu verschließen, und
    • (b) Eingeben eines langlebigen Ausgangs-Radionuklids, das spontan zu einem relativ kurzlebigen Folge-Radionuklid verfallen kann, in die Säule (12), indem der Einlaß-Port (12I) der Säule (12) mit einer einem ersten Druck ausgesetzten Quelle des Ausgangs-Radionuklids verbunden wird, und indem gleichzeitig der Auslaß-Port (12E) der Säule (12) durch die Auslaßverbindungseinrichtung (26F,26N) mit einem Bereich verbunden wird, der einem zweiten, niedrigeren Druck ausgesetzt ist,
    gekennzeichnet durch die folgenden Schritte:
    • (c) Verschließen der Auslaßverbindungseinrichtung mit einer abnehmbaren Abdeckung (38), die einen Entlastungsauslaß (38V) und ein darin stromabwärts von der Auslaßverbindungseinrichtung (26F,26N) angeordnetes Filter (38F) aufweist,
    • (d) Sterilisation des Generators (10), wobei sämtliche während der Sterilisation erzeugten Gase durch den in der Abdeckung (38C) angeordneten Entlastungsauslaß (38V) entlüftet werden.
  8. Verfahren nach Anspruch 7, bei dem an den Einlaß-Port (12I) ferner eine separate Einlaßströmungsleitung (18F) angeschlossen ist und in Schritt (b) der Einlaß-Port (12I) durch die separate Einlaßströmungsleitung (18F) mit der Quelle des Ausgangs-Radionuklids verbunden ist.
Anspruch[en]
  1. A radionuclide generator (10) having
    • a column (12) having a long-lived parent radionuclide and a relatively short-lived daughter radionuclide therein,
    • the column (12) having an inlet port (12I) and an outlet port (12E), means (18) for connecting the inlet port (12I) of the column (12) to a source of eluant, and means (12B3, 26F, 26N) for connecting the outlet port (12E) to an eluate collection vessel,
    • a plug (36) removably mounted to the inlet connecting means (18) to seal the same,
    • a cover (38C) removably mounted to the outlet connecting means (26N), and
    • a filter (38F) being arranged downstream of the outlet port (12E),
    characterized by
    • the cover (38C) having a vent (38V) and the filter being (38F) disposed therein downstream of the outlet connection means (12B3, 26F, 26N),
    • whereby gases produced during sterilization of the generator (10) are vented through the cover (38C).
  2. The radionuclide generator of claim 1, characterized by charging means (12B2,30F,32) connected to the inlet port (12I) of the column (12) for charging the same with a parent radionuclide, the charging means (12B2,30F,32) being separate from the inlet connecting means (18).
  3. The radionuclide generator of claim 2, characterized by the charging means (12B2,30F,32) comprising a charging flow line (30F) being connected to the inlet port (12I) of the column (12).
  4. The radionuclide generator of one of claims 1-3, characterized by a flow vent (20,22) for venting the source of eluant when the same is connected to the inlet connecting means (18N,18F,12B1,), the plug (36) also being removably mounted to the flow vent (20,22) to seal the same.
  5. The radionuclide generator of claim 4, characterized in that the flow vent (20,22) comprises a vent needle (20) for venting the source of eluant when the same is connected to the inlet needle (18N).
  6. The radionuclide generator of one of claims 1-5, characterized in that the inlet connecting means (18) comprises an inlet flow (18F) line terminating in an inlet needle (18N) for connecting the inlet port (12I) to a source of eluant, and the outlet means (12B3,26F,26N) comprises an outlet flow line (26F) terminating in an outlet needle (26N) for connecting the outlet port (12E) to an eluate collection vessel.
  7. A method of manufacturing a radionuclide generator (10) of the type having a column (12) having an inlet port (12I) and an outlet port (12E), the inlet port (12I) having inlet connection means (18) while the outlet port (12E) has outlet connection means (26F,26N) connected thereto, the method comprising the steps of
    • (a) plugging the inlet connection means (18) with a removable plug (36) to seal the same, and
    • (b) charging the column (12) with a long-lived parent radionuclide spontaneously decayable into a relatively short-lived daughter radionuclide by connecting the inlet port (12I) of the column (12) to a source of the parent radionuclide at a first pressure and by simultaneously connecting the outlet port (12E) of the column (12) through the outlet connection means (26F,26N) to a region having a second, lower pressure,
    characterized by the steps of
    • (c) covering the outlet connection means with a removable cover (38) having a vent (38V) and a filter (38F) disposed therein downstream of the outlet connection means (26F,26N), and
    • (d) sterilizing the generator (10), whereby any gases produced during sterilization are ventable through the vent (38V) in the cover (38).
  8. The method of claim 7, wherein the inlet port (12I) further has a separate inlet flow line (18F) connected thereto, and in step (b) the inlet port (12I) is connected to the parent radionuclide source through the separate inlet flow line (18F).
Anspruch[fr]
  1. Un générateur de radionucléide (10) comportant :
    • une colonne (12) renfermant un radionucléide père de période longue et un radionucléide descendant de période relativement courte, la colonne (12) comportant une ouverture d'entrée (12I) et une ouverture de sortie (12E), des moyens (18) de raccordement de l'ouverture d'entrée (12I) de la colonne (12) à une source d'éluant et des moyens (12B3, 26F, 26N) de raccordement de l'ouverture de sortie (12E) à un récipient de collecte de l'éluat ;
    • un bouchon (36) démontable installé sur les moyens de raccordement d'entrée (18) pour l'obturer ;
    • un couvercle (38C) démontable installé sur les moyens de raccordement de sortie (26N) ; et
    • un filtre (38F) disposé en aval de l'ouverture de sortie (12E),
    caractérisé en ce que :
    • le couvercle (38C) comportant une soupape (38V) et un filtre (38F) est disposé en aval des moyens de raccordement de sortie (12B3, 26F, 26N),
    • et par lequel les gaz libérés au cours de la stérilisation du générateur (10) sont dégazés à travers le couvercle (38C).
  2. Le générateur de radionucléide selon la revendication 1, caractérisé en ce que des moyens de chargement (12B2, 30F, 32) raccordés à l'ouverture d'entrée (12I) de la colonne (12) pour le chargement de celle-ci avec un radionucléide père, les moyens de chargement (12B2, 30F, 32) étant distincts des moyens de raccordement d'entrée (18).
  3. Le générateur de radionucléide selon la revendication 2, caractérisé en ce que les moyens de chargement (12B2, 30F, 32) comprennent une conduite de chargement (30F) raccordée à l'ouverture d'entrée (12I) de la colonne (12).
  4. Le générateur de radionucléide selon l'une quelconque des revendications 1 à 3, caractérisé en ce qu'il existe une soupape de sortie (20, 22) pour le dégazage de la source d'éluant lorsque celle-ci est raccordée aux moyens de raccordement d'entrée (18N, 18F, 12B1), le bouchon (36) étant également installé de manière amovible sur la soupape de sortie (20, 22) afin de l'obturer.
  5. Le générateur de radionucléide selon la revendication 4, caractérisé en ce que la soupape de dégazage (20, 22) comprend une aiguille de dégazage (20) pour le dégazage de la source d'éluant lorsque celle-ci est raccordée à l'aiguille d'entrée (18N).
  6. Le générateur de radionucléide selon l'une quelconque des revendications 1 à 5, caractérisé en ce que le moyen de raccordement d'entrée (18) comprend une conduite d'introduction (18F) se terminant par une aiguille d'entrée (18N) pour raccorder les ouvertures d'entrée (12I) à une source d'éluant, et en ce que les moyens de sortie (12B3, 26F, 26N) comprennent une conduite de sortie (26F) se terminant en une aiguille de sortie (26N) pour raccorder l'ouverture de sortie (12E) à un récipient de collecte de l'éluat.
  7. Un procédé de fabrication d'un générateur de radionucléide (10) du type ayant une colonne (12) comportant une ouverture d'entrée (12I) et une ouverture de sortie (12E), l'ouverture d'entrée (12I) comportant des moyens de raccordement d'entrée (18) tandis que l'ouverture de sortie (12E) comporte des moyens de raccordement de sortie (26E, 26N) qui lui sont associés, la méthode comprenant les étapes de:
    • (a) obturation des moyens de raccordement d'entrée (18) par un bouchon démontable (36) pour obturer celui-ci, et
    • (b) chargement de la colonne (12) avec un radionucléide père de période longue spontanément désintégrable en radionucléide descendant de période relativement courte, en raccordant l'ouverture d'entrée (12I) de la colonne (12) à une source de radionucléide père à une première pression et simultanément en raccordant l'ouverture de sortie (12E) de la colonne (12) par l'intermédiaire des moyens de raccordement de sortie (26F, 26N) à une région se trouvant sous une seconde pression plus basse,
    caractérisées par les étapes de :
    • (c) recouvrement des moyens de raccordement de sortie par un couvercle démontable (38) comportant une soupape (38V) et un filtre (38F) disposé en son sein en aval des moyens de raccordement de sortie, et
    • (d) stérilisation du générateur (10), dans lequel tout gaz produit au cours de la stérilisation est dégazable par les soupapes (38V) dans le couvercle (38).
  8. Le procédé selon la revendication 7, dans lequel l'ouverture d'entrée (12I) comporte en outre une conduite d'introduction séparée (18F) qui est raccordée à elle et, dans l'étape (b), l'ouverture d'entrée (12I) est raccordée à la source de radionucléide père par l'intermédiaire d'une conduite d'introduction séparée (18F).






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