JP2018169197A - Quality verification device - Google Patents

Abstract

To provide a quality verification device which drips a liquid with an accurate number of droplets to a verification part.SOLUTION: A quality verification device 1 includes a stock solution vial arranging part 3, a quality verification part 2, a waste liquid part 25 of a radioactive agent R, a syringe S movable to the stock solution vial arranging part 3, the quality verification part 2 and the waste liquid part 25, and a control unit 10 for controlling the operation of the syringe S. The control unit 10 controls the operation of the syringe S to execute a first step of sucking the radioactive agent R from the stock solution vial arranging part 3, a second step of discharging a part of the radioactive agent R sucked in the first step to the waste liquid part 25, a subsequent third step of bringing a side surface of a tip portion of an injection needle into contact with the waste liquid part 25, and a fourth step of dropping the radioactive agent to the quality verification part 2 after the third step.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a quality testing apparatus for performing quality testing of a plurality of items of radiopharmaceuticals.

  Conventionally, as a technique in such a field, as disclosed in Patent Document 1, a quality inspection apparatus is known in which quality inspections for different items are executed in a plurality of quality inspection units. In this apparatus, the radiopharmaceutical contained in the stock solution vial is sucked into the syringe, the syringe is moved, and the necessary amount of radiopharmaceutical is supplied from the syringe to each quality test unit in the apparatus.

JP 2014-182114 A

  In this type of apparatus, depending on the contents of the quality test, it may be required to drop the liquid medicine into the quality test unit with an accurate number of drops. However, as the state of the syringe immediately before dropping, there are also a state where the syringe needle is not sufficiently filled with liquid and a state where extra liquid overflowing from the injection needle is attached to the needle tip part. obtain. As described above, if the liquid state of the injection needle of the syringe immediately before dropping is unstable, it is extremely difficult to control the dropping of the liquid with the correct number of drops to the test unit. In view of this problem, an object of the present invention is to provide a quality verification device that drops liquid with an accurate number of drops to the verification unit.

  The quality verification apparatus of the present invention is a quality verification apparatus for performing a quality test of a radiopharmaceutical, wherein a drug storage section for storing the radiopharmaceutical, a quality verification section for performing a quality test of the radiopharmaceutical, and the radiopharmaceutical are discarded. A syringe part that can be moved to a waste liquid part, a drug storage part, a quality test part, and a waste liquid part, and capable of inhaling and discharging a radioactive medicine with an injection needle, an operation of moving the syringe part, and a syringe part A control unit that controls the operation of inhaling and discharging the radiopharmaceutical, and the control unit includes a first step in which the syringe unit inhales the radiopharmaceutical from the drug storage unit, and a syringe unit in the first step. A second step of discharging a part of the inhaled radiopharmaceutical to the waste liquid part; a syringe part having a third step of bringing the side surface of the needle tip of the injection needle into contact with the waste liquid part after the second step; The third step After flop, it controls the operation of the syringe unit so as to perform their tips reset operation with a fourth step of dropping the radiopharmaceutical to the quality test unit.

  In addition, the waste liquid part includes a container part for storing the radiopharmaceutical to be discarded and a film part that is provided in the opening of the container part and can be penetrated by the injection needle. In the second step, the injection needle penetrates the film part. So that the radiopharmaceutical is discharged from the injection needle into the container portion, and in the third step, the needle is pulled out of the membrane portion, so that the needle is attached to the edge of the through hole formed in the membrane portion. You may make it the side surface of a front part contact.

  Further, the film part may be made of metal.

  The quality verification apparatus of the present invention is a quality verification apparatus for performing a quality test of a radiopharmaceutical, wherein a drug storage section for storing the radiopharmaceutical, a quality verification section for performing a quality test of the radiopharmaceutical, and the radiopharmaceutical are discarded. A waste liquid bottle, a membrane part covered by the opening of the waste liquid bottle, a drug storage part, a quality test part, and a waste liquid part, which can be moved to and inhaled and discharged with the injection needle. And a control unit that controls the operation of moving the syringe unit and the operation of inhaling and discharging the radiopharmaceutical by the syringe unit, and the control unit includes the syringe unit from the drug storage unit. The syringe part descends so that the radiopharmaceutical is inhaled, and the syringe needle is inserted into the waste liquid bottle while penetrating the membrane part, and the syringe part discharges a part of the inhaled radiopharmaceutical to the waste liquid part. Is pulled out of the membrane Syringe portion rises as the syringe unit to control the operation of the syringe unit so as dropping the radiopharmaceutical to the quality assay portion.

  ADVANTAGE OF THE INVENTION According to this invention, the quality verification apparatus which performs the dripping of the liquid with the exact number of drops with respect to a test | inspection part can be provided.

It is a front view which shows the quality verification part of a quality verification apparatus. (A)-(c) is a figure which shows the motion of the injection needle in the waste-liquid bottle vicinity. (A)-(c) is a figure which shows a movement of the injection needle in a waste-liquid bottle vicinity, following FIG.

  Hereinafter, an embodiment of a quality verification apparatus according to the present invention will be described in detail with reference to the drawings.

As shown in FIG. 1, the quality verification apparatus 1 stores a plurality of quality verification units 2 that automatically perform quality verification of predetermined items of a liquid radiopharmaceutical R, and stores quality verification units 2 to shield radiation. The hot cell 4 is provided. Examples of the radiopharmaceutical R targeted by the quality test apparatus 1 include ¹⁵ O-water, ¹¹ C-methionine, ¹⁸ F-FDG (fluorodeoxyglucose) labeled with a relatively short-lived positron radionuclide. Is mentioned. The hot cell 4 suppresses radiation to the outside of the apparatus due to the radionuclide as described above. The hot cell 4 is not a room for people to enter, such as a room covered entirely with a radiation shielding wall, but is provided in the room and is a radiation shielding wall for storing the quality verification unit 2. The radiopharmaceutical R is synthesized by a predetermined synthesizer (not shown), and then introduced into the quality certifier 1 for quality verification.

  As shown in FIG. 2, the quality verification apparatus 1 includes a stock solution vial placement unit 3 (medicine storage unit) in which a stock solution vial 3 a in which a radiopharmaceutical R is accommodated is placed. Moreover, the quality verification apparatus 1 includes a cleaning liquid storage unit 11 that stores a cleaning liquid for cleaning a syringe S (syringe unit), which will be described later, and an extraction vial arrangement unit 12 in which an extraction vial 12a is arranged.

  Furthermore, the quality verification apparatus 1 includes a syringe drive unit 9 for holding the syringe S and moving it in the hot cell 4, and a control unit 10 for controlling the operation of the syringe drive unit 9. The syringe drive unit 9 holds the syringe S for inhaling and discharging the radiopharmaceutical R in an upright posture with the tip of the injection needle facing downward. The syringe drive unit 9 translates the syringe S in a biaxial direction in a plane parallel to the paper surface of FIG. 1 according to a control signal from the control unit 10. Further, the syringe drive unit 9 can pull up and push down the piston of the syringe S by a control signal from the control unit 10, and liquid suction into the syringe S and liquid discharge from the syringe S are executed.

  Based on the control by the control unit 10, the syringe drive unit 9 operates the held syringe S to collect the radiopharmaceutical R in the stock solution vial 3 a, moves the syringe S, and supplies each quality test unit 2 with a necessary amount. The radiopharmaceutical R is dripped or injected. In each quality test part 2, the test | inspection of a different test item is each performed about the radiopharmaceutical R dripped or inject | poured.

  After the dropping or injection of the radiopharmaceutical R to each quality test unit 2 is completed, the syringe drive unit 9 moves the syringe S to the extraction vial placement unit 12 and injects the radiopharmaceutical R into the extraction vial 12a. . The radiopharmaceutical R subdivided into the takeout vials 12a is taken out of the apparatus and used for quality verification of items that cannot be performed by each quality verification unit 2. Thereafter, the syringe drive unit 9 moves the syringe S to the cleaning liquid storage unit 11 and sucks and discharges the cleaning liquid to clean the syringe S. For example, distilled water is used as the cleaning liquid stored in the cleaning liquid storage unit 11.

  The quality test unit 2 to which the radiopharmaceutical R is dropped or injected as described above includes, for example, an HPLC analysis unit 21, an endotoxin measurement unit 22, a sterility test unit 23, and a dropping table 24. Various test papers 24a are set on the upper surface of the dropping table 24, and the radiopharmaceutical R from the syringe S is dropped onto each of the test papers 24a. For example, the test paper 24a includes a TLC test paper for a TLC (thin layer chromatograph) test, which is one of the test items.

  Some of the tests executed by the quality test unit 2 require that the radiopharmaceutical R be dropped into the quality test unit 2 with an accurate number of drops due to the nature of the test. For example, in the TLC test, it is necessary to reliably drop one drop of the radiopharmaceutical R onto the TLC test paper on the dropping table 24. However, as a state of the syringe S immediately before dropping, a state in which the radiopharmaceutical R is not sufficiently filled in the injection needle of the syringe S, or an extra droplet overflowing from the injection needle adheres to the needle tip. There may be a state of being. Thus, if the liquid state of the injection needle of the syringe S immediately before dropping is unstable, it is very difficult to control the dropping of the radiopharmaceutical R having the exact number of drops to the quality test unit 2. 2A, the tip 15a of the syringe 15 of the syringe S is sharpened by forming the tip surface 15a obliquely with respect to the direction in which the syringe 15 extends. A needle tip is formed.

  As a countermeasure against the above problems, the quality verification apparatus 1 has a mechanism described below. The quality test apparatus 1 has a waste liquid section 25 for storing the radiopharmaceutical R to be discarded at any position within the movement range of the syringe S (here, a position adjacent to the cleaning liquid storage section 11). Is provided. The waste liquid part 25 includes a waste liquid bottle 13 (container part) and a film part 14. The waste liquid bottle 13 is a bottomed container having an opening 13a at the upper end, and stores the radiopharmaceutical R to be discarded. The film part 14 is put on the upper part of the waste liquid bottle 13 so as to close the opening 13 a of the waste liquid bottle 13. The membrane part 14 is made of a material that can be penetrated relatively easily by the injection needle of the syringe S. For example, here, description will be made assuming that an aluminum foil 14 is used as the film part 14.

  When dropping the radiopharmaceutical R to the quality test unit 2 (for example, TLC test paper) that requires the accurate drop number drop, the control unit 10 performs the operations of the first to fourth steps described below. Thus, the syringe drive unit 9 is controlled. Among these operations, the operations of the first to third steps are executed as pre-processing immediately before dropping the radiopharmaceutical R to the quality testing unit 2, and the operations of the first to third steps are hereinafter referred to as “needle tips”. This is called “reset operation”.

(First step)
First, the control unit 10 moves the syringe S to the stock solution vial placement unit 3 and inhales the radiopharmaceutical R in the stock solution vial 3a into the syringe S.

(Second step)
Next, as shown in FIG. 2A, the syringe S is moved immediately above the waste liquid bottle 13. 2 to 3 show only the injection needle 15 of the syringe S in an enlarged manner. Next, as shown in FIG. 2B, the control unit 10 lowers the syringe S and inserts the injection needle 15 into the waste liquid bottle 13. For example, the syringe S may be lowered vertically below here. When the syringe S is lowered, the injection needle 15 passes through the aluminum foil 14 placed on the opening 13 a of the waste liquid bottle 13 and is inserted to a depth in the middle of the waste liquid bottle 13. Through the penetration of the injection needle 15, a through hole 14a is formed in the aluminum foil 14, and the injection needle 15 is inserted into the through hole 14a. Next, the control unit 10 pushes down the piston of the syringe S to discharge a part of the radiopharmaceutical R inhaled in the first step. Thereby, for example, several drops of the radiopharmaceutical R are dropped from the injection needle 15 into the waste liquid bottle 13. After the radiopharmaceutical R is discharged from the injection needle 15 in this way, the droplet R1 of the radiopharmaceutical R remains in the needle tip portion of the injection needle 15 as shown in FIG.

(Third step)
Thereafter, as shown in FIGS. 3B and 3C, the control unit 10 raises the syringe S and pulls out the injection needle 15 from the waste bottle 13 and the aluminum foil 14. For example, here, the syringe S may be raised vertically upward. In the middle of the raising of the injection needle 15, the side surface of the needle tip portion of the injection needle 15 moves so as to contact and rub the edge portion of the through hole 14 a of the aluminum foil 14. As a result, as shown in FIG. 3B, the droplet R1 at the tip of the needle is separated from the injection needle 15 so as to be wiped off at the edge of the through-hole 14a of the aluminum foil 14, and inside the waste bottle 13 Fall into. As a result, when the injection needle 15 is completely pulled out from the aluminum foil 14, as shown in FIG. 3C, the injection needle 15 is filled with the radiopharmaceutical R without excess or deficiency, and the needle tip. The droplet R1 adhering to the part does not exist. In order to ensure that the side surface of the needle tip of the injection needle 15 is brought into contact with the edge of the through-hole 14a while the injection needle 15 is being raised, the syringe S is slightly moved in the horizontal direction before the syringe S is raised. It may be moved. This completes the needle point reset operation.

(4th step)
After the above-described needle tip reset operation, the control unit 10 moves the syringe S directly above the quality verification unit 2 that requires the dropping of the correct number of drops, while controlling the push-down amount of the piston of the syringe S. Then, the radiopharmaceutical R having the required number of drops is dropped onto the quality test unit 2.

  The effect by performing the above-mentioned needle tip reset operation is explained. Regardless of the state of the injection needle 15 before the needle tip reset operation (the state shown in FIG. 2A), the state shown in FIG. 3C appears with high reproducibility when the needle tip reset operation is completed. it is conceivable that. That is, according to the above-described needle point reset operation, the syringe S is filled with the radiopharmaceutical R up to the needle point of the injection needle 15 and there is no droplet R1 attached to the needle point part. Can do. Therefore, immediately after the needle tip reset operation, the control unit 10 can drop the radiopharmaceutical R having the exact number of drops into the quality test unit 2 by controlling the amount of depression of the piston of the syringe S.

  In the third step described above, it is not essential for the injection needle 15 to come into contact with the edge of the through hole 14a during the ascent. Even when the injection needle 15 moves up without contacting the edge of the through hole 14a, the side surface of the injection needle 15 passes through a position very close to the edge of the through hole 14a. The liquid droplet R1 itself that protrudes in the horizontal direction from the side surface of the liquid crystal contacts the edge of the through hole 14a with a high probability, and the liquid droplet R1 is removed from the injection needle 15.

  The present invention can be implemented in various forms including various modifications and improvements based on the knowledge of those skilled in the art including the above-described embodiments. Moreover, it is also possible to configure a modification of the example using the technical matters described in the above-described embodiment. You may use combining the structure of each embodiment suitably.

  For example, the film part that covers the opening 13 a of the waste liquid bottle 13 is not limited to the aluminum foil 14, and various film parts can be used as long as the injection needle 15 is strong enough to penetrate. be able to. For example, a metal film (metal foil) made of various materials, typically the aluminum foil 14, may be used as the film portion. Generally, before installing the waste liquid bottle 13 in the quality verification apparatus 1, it is necessary to sterilize the waste liquid bottle 13. In such a case, it is preferable to employ a metal film as the film part because the waste liquid bottle 13 can be sterilized by dry heat with a high-temperature sterilizer while the metal film is covered. Moreover, since it is preferable that the magnitude | size of the through-hole 14a does not change during needle-tip reset operation | movement, it is preferable that a film | membrane part consists of a non-stretchable material. The film portion is not limited to a metal film, and may be a film made of another material such as a resinous film.

  In order to remove the droplet R1, it is also conceivable to employ a film part (for example, a film part made of nonwoven fabric) having a characteristic of absorbing liquid. However, in this case, the radiopharmaceutical R inside the injection needle 15 may be sucked out together, and there is a possibility that the amount of the radiopharmaceutical R filled in the injection needle 15 may vary. Therefore, it is preferable to employ a material that does not absorb liquid as the material of the film part.

  Also, as shown in FIG. 3A, the droplet R1 remaining at the tip of the injection needle 15 tends to swell in the direction of the opening of the needle tip (to the right in the example of FIG. 3A). Therefore, in order to remove such a droplet R1, of the side surfaces of the injection needle 15, one side surface (the right side surface in the example of FIG. 3A) contacts the waste liquid portion 25. do it. Therefore, it is not essential that the waste liquid part 25 includes the film part 14. That is, for example, in the needle tip reset operation, control is performed so that one side surface of the needle tip portion of the injection needle 15 in which the droplet R1 is generated is brought into contact with the inner wall surface of the waste liquid bottle 13 or the edge portion of the opening 13a of the waste liquid bottle 13. May be. Further, a detection means for detecting the direction of the opening of the needle tip of the injection needle 15 is prepared, and the injection needle 15 is applied to the inner wall surface of the container of the waste liquid bottle 13 from any direction based on the detected direction of the opening of the needle tip. You may control to contact.

  DESCRIPTION OF SYMBOLS 1 ... Quality verification apparatus, 3 ... Stock solution vial arrangement | positioning part (medicine storage part), 9 ... Syringe drive part, 10 ... Control part, 13 ... Waste liquid bottle (container part), 14 ... Aluminum foil (film | membrane part), 14a ... Through Hole: 15 ... Injection needle, 24 ... Dropping table, 25 ... Waste liquid part, S ... Syringe, R ... Radiopharmaceutical.

Claims (4)

A quality test apparatus for performing a quality test of a radiopharmaceutical,
A drug reservoir in which the radioactive drug is stored;
A quality tester for performing a quality test of the radiopharmaceutical,
A waste liquid part where the radiopharmaceutical is discarded;
A syringe part that is movable to the drug storage part, the quality verification part and the waste liquid part, and capable of inhaling and discharging the radioactive medicine with an injection needle;
A control unit for controlling the movement of the syringe unit and the operation of inhaling and discharging the radiopharmaceutical by the syringe unit;
The controller is
A first step in which the syringe unit inhales the radiopharmaceutical from the drug reservoir;
A second step in which the syringe part discharges a part of the radiopharmaceutical inhaled in the first step to the waste liquid part;
A third step in which, after the second step, the syringe part makes the side surface of the needle tip part of the injection needle contact the waste liquid part;
The quality verification apparatus which controls operation | movement of the said syringe part so that the said syringe part may perform the 4th step which dripping the said radiopharmaceutical to the said quality verification part after the said 3rd step. The waste liquid part includes a container part that stores the radiopharmaceutical to be discarded, and a film part that is provided in an opening of the container part and through which the injection needle can pass.
In the second step,
The injection needle is inserted into the container part so as to penetrate the membrane part, and the radiopharmaceutical is discharged from the injection needle into the container part,
In the third step,
The quality tester according to claim 1, wherein a side surface of the needle tip part comes into contact with an edge part of a through hole formed in the film part by pulling out the injection needle from the film part.   The quality inspection apparatus according to claim 2, wherein the film part is made of metal. A quality test apparatus for performing a quality test of a radiopharmaceutical,
A drug reservoir in which the radioactive drug is stored;
A quality tester for performing a quality test of the radiopharmaceutical,
A waste liquid part having the waste liquid bottle in which the radiopharmaceutical is discarded, and a film part placed on the opening of the waste liquid bottle;
A syringe part that is movable to the drug storage part, the quality verification part and the waste liquid part, and capable of inhaling and discharging the radioactive medicine with an injection needle;
A control unit for controlling the movement of the syringe unit and the operation of inhaling and discharging the radiopharmaceutical by the syringe unit;
The controller is
The syringe part inhales the radiopharmaceutical from the drug reservoir, the syringe part descends so that the injection needle is inserted into the waste bottle while penetrating the membrane part, and the syringe part is the radiopharmaceutical. The syringe part is discharged so that the syringe needle is pulled out from the membrane part, and the syringe part drops the radiopharmaceutical on the quality test part. Quality verification device that controls the operation of

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