TWI615153B - Kit for radioactive drug manufacturing system and radiopharmaceutical manufacturing system - Google Patents

Abstract

The present invention provides a kit for a radiopharmaceutical manufacturing system and a radiopharmaceutical manufacturing system capable of manufacturing radiopharmaceuticals that improve ease of use and further ensure quality. The kit (10) for a radiopharmaceutical manufacturing system includes an information holding unit of at least one of a substrate (13), a piping (12), and information on the number of times of use of the holder kit (10) and identification information of the kit (10). (11). The radiopharmaceutical manufacturing system (1) includes a fixing unit (4) capable of fixing the radiopharmaceutical manufacturing system cover assembly (10) in a removable manner, and an information reading unit (reading information) 5). Therefore, on the system (1) side, it is possible to easily grasp the usage frequency information and identification information, and it is possible to avoid using a package exceeding a predetermined number of times and perform various processes using the identification information.

Description

Kit for radiopharmaceutical manufacturing system and radiopharmaceutical manufacturing system

The invention relates to a sleeve assembly for a radiopharmaceutical manufacturing system and a radiopharmaceutical manufacturing system.

For example, radioisotope-labeled compounds (RI compounds) used in PET inspections (positron emission tomography) in hospitals and the like are RIs that perform a chemical reaction between a radioisotope (RI: Radio Isotope) and a predetermined raw material reagent. Compound synthesis equipment. Patent Document 1 discloses a radiopharmaceutical manufacturing system having such a synthesis device. The radiopharmaceutical manufacturing system includes a fixed module and a disposable module that fixes a plurality of pipes on a substrate. In this radiopharmaceutical manufacturing system, once the synthesis is completed, the disposable module is replaced with a new one to prepare for the next synthesis.

(Prior technical literature) (Patent Literature)

Patent Document 1: Japanese Patent Publication No. 2004-515330

Here, various problems occur in the above-mentioned radiopharmaceutical manufacturing system. For example, the disposable module may be used up to a predetermined number of times in addition to being replaced each time. However, in the above-mentioned radiopharmaceutical manufacturing system, it takes a lot of time to grasp how many disposable modules are used, and there is a risk that the disposable modules will be used even if it exceeds a predetermined number of times. Therefore, the sterilization performance of the disposable module may be deteriorated, or impurities may be mixed into the radiopharmaceutical, etc., and there are problems in the quality assurance of the radiopharmaceutical. In addition, when multiple radiopharmaceuticals are manufactured using the same system, selecting the corresponding one-time module or setting the corresponding operation is quite laborious, and the selection or the device-side operation setting may be performed by mistake. Therefore, there is a need to manufacture a radiopharmaceutical that improves ease of use and further guarantees quality.

Therefore, an object of the present invention is to provide a kit for a radiopharmaceutical manufacturing system and a radiopharmaceutical manufacturing system capable of manufacturing a radiopharmaceutical with improved ease of use and further guaranteed quality.

The kit for a radiopharmaceutical manufacturing system of the present invention is a kit for a radiopharmaceutical manufacturing system suitable for a radiopharmaceutical manufacturing system for manufacturing a radiopharmaceutical in a replaceable manner, and is characterized by having a substrate, a pipe mounted on the substrate, and a holder. An information holding unit for at least one of the usage frequency information and the identification information regarding the number of uses.

In the kit for a radiopharmaceutical manufacturing system, in the case where the information holding section holds information on the number of uses, the system can easily grasp and release the information on the system side. The number of uses of the kit for a radiopharmaceutical manufacturing system. Therefore, it is possible to avoid using the kit for a radiopharmaceutical manufacturing system exceeding a predetermined number of times. In addition, when the identification information is held by the information holding unit, identification information of the kit for the radiopharmaceutical manufacturing system can be easily obtained on the system side. Thereby, various processes using the identification information can be performed. Therefore, it is possible to manufacture a radiopharmaceutical that improves the ease of use of the radiopharmaceutical manufacturing system and further guarantees the quality.

In the kit for a radiopharmaceutical manufacturing system of the present invention, it is preferable that the piping is mounted on the front surface side of the substrate, and the information holding portion is preferably mounted on the rear surface side of the substrate. With this configuration, the information holding unit can be mounted on a surface where no piping is present, and the information held by the information holding unit can be easily read on the system side.

In addition, the radiopharmaceutical manufacturing system of the present invention includes a fixing unit capable of fixing the above-mentioned radiopharmaceutical manufacturing system cover assembly in a removable manner, and an information reading unit that reads information held by the information holding unit.

This radiopharmaceutical manufacturing system can obtain the same effects as those of the kit for a radiopharmaceutical manufacturing system.

The radiopharmaceutical manufacturing system of the present invention preferably includes a first discrimination unit and a first warning unit. The first discrimination unit judges the number of uses of the kit for the radiopharmaceutical manufacturing system based on the information held by the information holding unit. The first warning The unit issues a warning when the number of uses determined by the first determining unit exceeds the prescribed number of uses. At this time, if the operator intends to use the kit for the radiopharmaceutical manufacturing system more than a predetermined number of times, a warning is issued by the first warning section, which can avoid the use of the kit for more than a predetermined number of times.

The radiopharmaceutical manufacturing system of the present invention includes a second determination unit and a control The second determination unit determines the type of radiopharmaceutical corresponding to the kit for the radiopharmaceutical manufacturing system based on the information held by the information holding unit, and the control unit performs the radiopharmaceutical determination with the second determination unit. The type is controlled accordingly. At this time, the control unit performs control corresponding to the type of the radiopharmaceutical discriminated by the second discriminating unit, so the radiopharmaceutical manufacturing system can perform an operation for manufacturing a radiopharmaceutical related to the discriminated species. Thereby, the operator can produce a desired radiopharmaceutical without any effort in selecting a kit for a radiopharmaceutical manufacturing system and setting a corresponding operation.

It is preferable that the radiopharmaceutical manufacturing system of the present invention includes a third determination unit and a second warning unit. The third determination unit judges the service life of the kit for the radiopharmaceutical manufacturing system based on the information held by the information holding unit, and the second warning The unit issues a warning when the use period judged by the third judging unit exceeds a prescribed use period. At this time, if the operator intends to use the kit that exceeds the prescribed use period, a warning is issued by the second warning section, which can avoid the use of the kit for the radiopharmaceutical manufacturing system that has exceeded the use period.

It is preferable that the radiopharmaceutical manufacturing system of the present invention includes an information storage unit, which is the identification information held by the memory information holding unit and the usage state of the kit for the radiopharmaceutical manufacturing system corresponding to the identification information. At this time, it is possible to obtain a record sheet about the usage state of the kit for the radiopharmaceutical manufacturing system corresponding to the identification information.

According to the present invention, it is possible to manufacture an improved radiopharmaceutical manufacturing system. The radiopharmaceuticals with usability and quality are further guaranteed.

1‧‧‧ Radiopharmaceutical Manufacturing System

4‧‧‧ fixed section

5‧‧‧ Information Reading Department

6‧‧‧Discrimination section (1st discrimination section, 2nd discrimination section, 3rd discrimination section)

7‧‧‧ warning section (1st warning section, 2nd warning section)

8‧‧‧Control Department

9‧‧‧ Information and Memory Department

10‧‧‧ Kit for radiopharmaceutical manufacturing system

11‧‧‧ Information Retention Department

12‧‧‧Piping

13‧‧‧ substrate

FIG. 1 is a block diagram showing a configuration of a radiopharmaceutical manufacturing system according to an embodiment of the present invention.

Fig. 2 is a perspective view showing the configuration of a synthesis unit as an example of the processing unit shown in Fig. 1.

FIG. 3 is a perspective view of the configuration of the solution adjustment unit as an example of the processing unit shown in FIG. 1.

Fig. 4 is a rear view of a configuration example of a sleeve assembly for a radiopharmaceutical manufacturing system according to an embodiment of the present invention.

Fig. 5 is a flowchart showing an example of processing contents of the radiopharmaceutical manufacturing system according to the embodiment of the present invention.

Hereinafter, an embodiment of the radiopharmaceutical manufacturing system kit and the radiopharmaceutical manufacturing system according to the present invention will be described in detail with reference to the drawings. In addition, the same elements are assigned the same elements in the description of the drawings, and redundant descriptions are omitted.

FIG. 1 is a block diagram showing the configuration of a radiopharmaceutical manufacturing system 1 according to this embodiment. The radiopharmaceutical manufacturing system 1 is a system for manufacturing radiopharmaceuticals (for example, ¹⁸ F-FDG, ¹¹ C-methionine, etc.) used in nuclear medicine inspections such as PET and SPECT. However, the radiopharmaceutical manufacturing system 1 may not include a process for generating a radioisotope from irradiation of a charged particle beam to a target, and the entire process until the radiopharmaceutical process is finally completed. It is constituted by the constituent elements of the manufacturing process. For example, the radiopharmaceutical manufacturing system 1 may be a system that proceeds until the radioisotope is refined, a system that synthesizes only the refined radioisotope, or a system that combines the two. As shown in FIG. 1, the radiopharmaceutical manufacturing system 1 includes a processing unit 2 and an information processing unit 3.

The processing unit 2 is used for the manufacturing process of the radiopharmaceuticals, and corresponds to the respective processes of the radiopharmaceuticals by applying the cover packs 10 for the radiopharmaceutical manufacturing system (hereinafter referred to as "cover packs 10") in a replaceable manner. Various units of processing. Examples of the processing unit 2 include a solution adjustment unit, a purification unit, and a synthesis unit. The solution adjusting unit is a person who adjusts the concentration of a solution in order to refine the radioisotope from a solution containing the radioisotope, and the refining unit is a person who refines the radioisotope from a solution. In addition, the synthesis unit is a person who chemically reacts a radioisotope with a predetermined raw material reagent. The radiopharmaceutical manufacturing system 1 includes one or a plurality of these various units. In addition, equipment, components, piping, and the like for manufacturing a radiopharmaceutical are provided on the upstream side and the downstream side of the processing unit 2. However, it is omitted in FIG. 1.

The processing unit 2 includes a fixing unit 4 for fixing the cover assembly 10 and an information reading unit 5 that reads information held by the information holding unit 11 of the cover assembly 10. In addition, the kit 10 includes an information holding unit 11 that holds various kinds of information.

The fixed part 4 of the processing unit 2 can be based on the manufactured radiopharmaceutical The various types of sleeve assemblies 10 are fixed in a removable manner. For example, the fixing unit 4 is a sleeve assembly 10A for fixing the radiopharmaceutical A when manufacturing the radiopharmaceutical A, and a sleeve assembly 10B for fixing the radiopharmaceutical B when manufacturing the radiopharmaceutical B. The detailed configuration of the fixing portion 4 will be described later.

The information holding unit 11 of the kit 10 holds at least one of the usage frequency information on the number of uses of the kit 10 and the identification information of the kit 10. The usage frequency information is information indicating how many times the kit 10 has been used, as long as it is related to the usage frequency, its appearance is not particularly limited. For example, it can be numerical information indicating the number of uses itself (count each time and keep the so-called "10" value information when used 10 times), or it can be information other than a value (for example, the so-called "used a specified number of times "). Alternatively, it can also be an indirect expression. For example, a certain mark is added each time it is used (for example, the punching hole 11C shown in FIG. 4 (c)), and the number of uses is expressed by the number of the mark.

The identification information is information for identifying the package 10, for example, identification information unique to the package 10 indicating the ID or number of each package 10 itself. In addition, the identification information may be, for example, the type of the radiopharmaceutical that can be manufactured by the kit 10 or the type of the kit 10, such as information indicating the group to which the kit 10 belongs or the property indicating the property of the kit 10 (except for the ID and other inherent In addition to the identification information, such information can also be included, but it can also include only the information without the ID and the like of each package). In addition, it can also include expiration date information, manufacturing date, and ex-factory date. The detailed configuration of the cover assembly 10 will be described later.

The information reading section 5 of the processing unit 2 reads the above information held by the information holding section 11 of the package 10 and sends the information to the information processing section 3. The detailed configuration of the information reading section 5 will be described later.

The information processing unit 3 performs control processing of the entire radiopharmaceutical manufacturing system 1. The information processing unit 3 performs control processing of the processing unit 2 and control processing of each constituent element in a system (not shown). The information processing unit 3 is physically constituted by a CPU, ROM, RAM, and the like (not shown). From a functional point of view, the information processing unit 3 includes a determination unit 6, a warning unit 7, a control unit 8, and an information storage unit 9. These performances are achieved by the CPU of the information processing unit 3 executing a computer program stored in a built-in memory such as a ROM or a RAM of the information processing unit 3.

The determination section 6 obtains various kinds of information about the package 10 held by the information holding section 11 through the information reading section 5. Then, various judgments and judgments corresponding to the acquired information are performed. For example, the determination unit 6 determines the number of times of use of the kit 10 based on the number of times of use information or identification information, and determines whether the number of times of use exceeds the predetermined number of times of use. In addition, the judging unit .6 judges the type of the medicine corresponding to the kit 10 or the use period of the kit 10 based on the identification information, and determines whether the use period has exceeded a predetermined use period.

When the judging unit 6 judges the number of times of use based on the number of times of use, it analyzes the obtained number of times of use to determine the number of times of use of the kit 10. When the number of times of use information is numerical information indicating the number of times of use, the determination section 6 can directly determine the number of times of use, and when the number of times of use is information In the case of indirect expression (for example, punching 11C shown in FIG. 4 (c)), the number of uses is determined by a predetermined calculation process. The processing unit 2 preferably has a structure that when the kit 10 is used, the use is reflected in the usage frequency information held by the information holding unit 11 of the kit 10 (not shown). Thereby, each time the kit 10 is used, the determination unit 6 can obtain new usage frequency information and determine the latest usage frequency via the information reading unit 5. In addition, when the cover assembly 10 is removed and used again or when used in other systems, the information holding unit 11 is still in a state of holding the usage frequency information which is also reflected in the cumulative usage times in the past, so the determination unit 6 can determine and consider The number of usages accumulated in the past.

When the judging unit 6 uses the identification information to determine the number of times of use, the set 10 corresponding to the identification information (here, the identification information unique to each set 10 such as an ID) is performed each time in a specific state. By counting, the number of uses of the set of components 10 can be discriminated. The determination unit 6 can determine whether the number of uses is within a predetermined number by referring to a count (the number of uses) corresponding to the kit 10 having the identification information. The count at this time may be limited to the user at the time (for example, the package 10 may be removed from the processing unit 2 before reaching a predetermined number of times), or it may be stored in the information memory 9 or External server 100. With this, when the sleeve assembly 10 is removed and used again, or when used in other systems, the determination unit 6 can also determine the information storage unit stored in the radiopharmaceutical manufacturing system 1 by querying the ID and the like obtained. 9 or past cumulative usage times in the external server 100. In addition, the judging unit 6 can judge the set 10 by directly reading the information held by the information holding unit 11. Information such as the type of radiopharmaceuticals, the expiration date, etc., but can also be determined from the information stored in the radioactive pharmaceutical manufacturing system 1 itself or the database in the external server 100 by searching the ID and other information obtained. .

The warning section 7 issues a warning based on the result of the determination and determination by the determination section 6. For example, when the judging unit 6 determines that the use period of the kit 10 has expired, or when it determines that the number of uses of the kit 10 exceeds a predetermined number, the warning unit 7 issues a warning. In addition, when a radiopharmaceutical of a type that cannot be manufactured with the cover assembly 10 is to be produced, the warning unit 7 may issue a warning when the cover assembly 10 is provided. These warnings can be performed in various forms, such as a warning display on a monitor, output of a warning sound, locking the fixing portion 4 so that the cover assembly 10 cannot be installed, or locking the radiopharmaceutical manufacturing system 1 itself so that it cannot operate.

The control unit 8 performs various controls based on the results determined by the determination unit 6. For example, when the determination unit 6 determines the type of medicine corresponding to the kit 10, the control unit 8 performs control corresponding to the type. The processing content for performing this control may exist in the control unit 8 or the information storage unit 9, or may exist in the kit 10. And various controls can be carried out automatically, and can also be performed after the operator's operation.

The information storage unit 9 has a function of storing various information used in the radiopharmaceutical manufacturing system 1. In addition, the information storage unit 9 also has the performance of memorizing the identification information held by the information holding unit 11 and the usage pattern of the package 10 corresponding to the identification information. For example, the information storage unit 9 memorizes the number of use times and use days of the package 10 corresponding to the obtained identification information. Information such as period, place of use (device used), user, etc. is better.

Next, the structures of the processing unit 2 and the cover assembly 10 will be described in more detail. First, referring to FIG. 2 and FIG. 3, a schematic configuration of the processing unit 2 and the cover assembly 10 will be described. FIG. 2 is a perspective view of the configuration of the synthesis unit 15 as an example of the processing unit 2, and FIG. 3 is a perspective view of the configuration of the solution adjustment unit 16 as an example of the processing unit 2.

The processing unit 2 is configured by assembling various containers, piping, and the like in a device provided with a sensor, a pump, a drive unit, a valve, a mechanism, and the like necessary for performing a desired process. In the device constituting the processing unit 2, a pressing unit S is provided at a position facing the through hole of the cover unit 10 described later. The pressing unit S is configured by, for example, an air cylinder that moves forward and backward by air pressure.

The cover assembly 10 includes a substrate 13 and a pipe 12. The substrate 13 is a substantially rectangular one made of a resin material such as polypropylene, silicone resin, polyurethane, ethylene-tetrafluoroethylene copolymer, Teflon (registered trademark), and has a plurality of holding portions F to which the pipe 12 can be mounted. . By attaching the piping 12 to a part of the plurality of holding portions F, a desired piping configuration can be formed.

The piping 12 fixed to the assembly 10 of the processing unit 2 is connected to various containers in the processing unit 2 and external equipment or components of the processing unit 2. The piping 12 mounted on the sleeve assembly 10 is pressed by the pressing assembly S of the processing unit 2. Then, the pipe 12 is pushed open or closed by the back-and-forth movement of the pressing unit S, and the flow path is freely set. In addition, a through hole is provided in the substrate 13 at a position facing the pressing member S, and is provided to extend from the mounting surface of the substrate toward the through holes. The protruding portion is preferred. By sandwiching the piping 12 by the pressing unit S and the protruding portion, the piping 12 can be pushed more reliably.

According to the processing unit 2 and the sleeve assembly 10, a desired piping configuration can be formed by installing the piping 12 in a part of the plurality of holding portions F, and the flow path can be freely set by controlling the pressing assembly S. Therefore, One substrate 13 can form a flow path for manufacturing a desired medicine. As a result, a plurality of types of radiopharmaceuticals can be manufactured using a single substrate 13. In addition, a plurality of types of radiopharmaceuticals can be produced by one processing unit 2 by changing the cover assembly 10.

Specifically, as shown in FIG. 2, the synthesis unit 15 includes a main body portion 41 and a lid portion 42, and is equipped with a reactor and the like for performing synthesis of a radiopharmaceutical containing a labeled compound by reacting raw materials. A fixing portion 4 is provided on the front surface of the main body portion 41, and the sleeve assembly 10 can be mounted by the fixing portion 4. The cover portion 42 is provided so as to be able to be opened and closed 90 degrees in the direction of the arrow A via a hinge provided on the main body portion 41. A plurality of pressing units S are provided at predetermined positions inside the cover portion 42. By attaching the cover assembly 10 to the fixing portion 4 and closing the lid portion 42, the pressing assembly S can press the pipe 12. With this, the pressing unit S is moved forward and backward, and the pipe 12 is pushed open or returned, so that the flow path can be formed freely.

As shown in FIG. 3, the solution adjustment unit 16 includes a main body portion 41 and a cover portion 42. A fixing portion 4 is provided on the front surface of the main body portion 41, and the cover assembly 10 can be mounted by the fixing portion 4. The cover portion 42 is provided so as to be openable and closable approximately 180 degrees in the direction of the arrow B via a hinge provided on the main body portion 41. A plurality of pressing units S are provided at predetermined positions inside the cover portion 42. versus The above-mentioned combining unit 15 is the same, and by attaching the cover assembly 10 to the fixing portion 4 and closing the lid portion 42, the pressing assembly S can press the pipe 12. With this, the pressing unit S is moved forward and backward, and the pipe 12 is pushed open or returned, so that the flow path can be formed freely.

Next, the configuration of the cover assembly 10 will be described in more detail with reference to FIG. 4. FIG. 4 is a rear view of a configuration example of the cover assembly 10 used in the radiopharmaceutical manufacturing system 1. As shown in FIG. 4, in the cover assembly 10, the information holding unit 11 (11A, 11B, 11C, 11D) can be read from the back surface 13 a side of the substrate 13. The pipe 12 is mounted on the front surface side of the substrate 13, and the information holding portion 11 (11A, 11B) is mounted on the back surface 13 a side of the substrate 13. The information holding unit 11 includes, for example, a barcode 11A, an IC chip 11B, a punched hole 11C, and a notched portion 11D.

The barcode 11A shown in FIG. 4 (a) is an identification code that represents the value or text by the thickness of the stripe-shaped line. According to certain rules, the information about the package 10 can be converted into a one-dimensional barcode and used as a digit. Output. In addition, the barcode 11A is not limited to a one-dimensional barcode, and may be converted into a multi-dimensional barcode. No new information can be written for this barcode 11A. However, after the sleeve assembly 10 is used in one processing unit 2 and removed, a new barcode 11A is issued and re-adhered. Thereby, it is possible to reflect the usage frequency information of the processing unit 2 in the new bar code 11A, and then to judge the past usage frequency when using the kit 10. The IC chip 11B shown in FIG. 4 (b) is an electronic component for storing information about the package 10 in advance, and a circuit mainly composed of a semiconductor is enclosed in a small package having a plurality of terminals. For this IC chip 11B, the sleeve assembly 10 is used each time Ability to write new usage information. The punching hole 11C shown in FIG. 4 (c) is a through-hole punched in the substrate 13 of the sleeve assembly 10 each time the sleeve assembly 10 is used (or a punching hole 11C may be formed with respect to multiple uses). The position or size of the notch portion 11D differs according to the identification information possessed by the kit 10. The notch 11D is used to judge the identification information of the kit 10 according to the position or size. When the punching hole 11C is used, the processing unit 2 is provided with a mechanism for forming the punching hole 11C on the substrate 13 of the sleeve assembly 10.

Various information reading sections 5 are used corresponding to these various information holding sections 11 (11A, 11B, 11C, 11D). For example, a barcode reader is used for the barcode 11A and an IC reader is used for the IC chip 11B. In addition, a light source sensor may be used for the punch 11C. When the light source sensor is used, specifically, the light should be irradiated to the part where the hole should be opened, and the light passing through the cover assembly 10 is detected in several places, thereby being able to read the number of times of use of the cover assembly 10. In addition, by irradiating light to a portion where the notch portion 11D should be provided, and detecting the position or size of the light passing through the cover assembly 10, the identification information of the cover assembly 10 can be read. In addition, the information reading section 5 may be provided in the processing unit 2 at a position where the cover assembly 10 is fixed, for example. Therefore, by fixing the cover assembly 10 to the fixing portion 4, the information reading portion 5 can directly read the information of the information holding portion 11. In addition, the information reading section 5 may be a dedicated reading device that is externally installed at a position remote from the fixed section 4. Thereby, the reading device can be easily replaced according to the state of the information holding portion 11 provided in the sleeve assembly 10.

Next, the operation of the radiopharmaceutical manufacturing system 1 according to this embodiment will be described with reference to FIG. 5. Figure 5 shows the processing inside the radiopharmaceutical manufacturing system 1. Flow chart of an example of content. Here, an example when the determination unit 6 determines the use life of the kit 10, the number of uses, and the type of the corresponding radiopharmaceutical will be described.

First, the cover assembly 10 is fixed to the fixing portion 4 in the processing unit 2 (step S1). Next, the information reading section 5 in the processing unit 2 reads the information about the package 10 held by the information holding section 11 (step S2). Next, the information storage unit 9 in the information processing unit 3 stores various kinds of information about the package 10 obtained through the information reading unit 5 (step S3).

Next, the judging section 6 in the information processing section 3 judges the use period of the kit 10 based on the information read in S2 (step S4). Then, the determination unit 6 determines whether the use period of the kit 10 has expired (step S5). When it is determined that the use period of the kit 10 has expired, the warning unit 7 issues a warning (step S7), and thereafter, the radiopharmaceutical manufacturing system 1 ends the operation.

On the other hand, when it is determined that the use period of the kit 10 has not expired, the determination unit 6 determines the number of uses based on the information read in step S2 (step S6). The determination unit 6 determines whether the number of uses of the kit 10 is equal to or less than a predetermined number of times (step S8). When it is determined that the number of uses of the kit 10 exceeds a predetermined number of times, the warning unit 7 issues a warning (step S7), and thereafter, the radiopharmaceutical manufacturing system 1 ends the operation.

On the other hand, when it is determined that the number of uses of the kit 10 is equal to or less than a predetermined number of times, the determination unit 6 determines the type of the radiopharmaceutical corresponding to the kit 10 based on the information read by S2 (step S9). In addition, when the kit 10 is capable of manufacturing a plurality of types of radiopharmaceuticals, the types that can be manufactured may also be displayed so that the operator can choose. Then, the control unit 8 starts Control is performed in accordance with the type of medicine determined by the determination section 6 (step S10). Thereby, since each component in the radiopharmaceutical manufacturing system 1 performs an operation for manufacturing a radioactive pharmaceutical of this kind, a desired pharmaceutical is manufactured (step S11), and the operation of the radiopharmaceutical manufacturing system 1 is completed. In addition, after S11, the information storage unit 9 may associate the unique identification information such as the ID of the package 10 with the usage pattern of the package 10 and memorize it. In addition, the information storage unit 9 may send the information to the server 100 or the information holding unit 11 of the package 10.

Next, functions and effects of the radiopharmaceutical manufacturing system kit 10 and the radiopharmaceutical manufacturing system 1 according to the present embodiment will be described.

In the case of the radiopharmaceutical manufacturing system kit and the radiopharmaceutical manufacturing system that do not use the information holding unit 5 described above, it is quite labor-intensive to grasp how many times the kit is used, and there is a risk of using the kit even if it exceeds a predetermined number of times. If this type of use is performed more than a specified number of times, the piping pushed by the pushing component cannot be restored to its original state, etc., which may adversely affect the function of freely setting the flow path by the pushing component. In addition, there is a possibility that the bactericidal performance is deteriorated and impurities are mixed in the radiopharmaceutical, etc., and there is a problem in quality assurance of the radiopharmaceutical.

In addition, in the case of the radiopharmaceutical manufacturing system kit and the radiopharmaceutical manufacturing system that do not use the information holding unit 5 described above, when a plurality of radiopharmaceuticals are manufactured by the same system, the wrong kit may be selected. The corresponding set of components or the corresponding action requires labor and time. In addition, when the wrong set of components is selected or the operation is set incorrectly, the desired radiopharmaceutical cannot be produced, or the quality is not affected. Good influence.

On the other hand, according to the radiopharmaceutical manufacturing system 1 and the kit 10 of the present embodiment, since the information holding unit 11 of the kit 10 has the number of times of use information or identification information, the information reading unit 5 can read the information. Information.

That is, by using the information reading unit 5 to read the number of times of use of the kit 10, the number of times of use of the kit 10 can be easily grasped on the radiopharmaceutical manufacturing system 1 side. Therefore, by using the grasped number of uses, it is possible to avoid using the kit 10 exceeding a predetermined number of times. This makes it possible to produce a radiopharmaceutical with guaranteed quality. In particular, when the kit 10 is temporarily removed from the radiopharmaceutical manufacturing system 1 and used again, or when the kit 10 was used in another radiopharmaceutical manufacturing system 1 in the past, it is read only by the information reading unit 5 The simple operation of the usage frequency information of the information holding unit 11 can easily grasp the usage frequency.

In addition, by reading the identification information of the kit 10 with the information reading unit 5, the identification information of the kit 10 can be easily obtained on the radiopharmaceutical manufacturing system 1 side. Thereby, it is possible to grasp the number of times of use of the kit 10 using the identification information, and it is possible to exhibit the same effect as in the case of obtaining the number of times of use information described above. In addition, the identification information can easily grasp the type and the like of the radiopharmaceutical corresponding to the kit 10, and the selection or operation setting of the kit 10 can be performed easily and accurately. This makes it possible to produce a radiopharmaceutical which improves the ease of use of the radiopharmaceutical production system 1 and further guarantees the quality.

In addition, according to the kit 10 and the information holding unit 11 of this embodiment It is attached to the back surface 13a side to which the pipe 12 is not attached. In this case, it is possible to attach the information holding unit 11 without considering the position of the piping 12, and it becomes easy to install the information holding unit 11. In addition, the presence of the piping 12 which becomes an obstacle when the reading is not performed on the back surface 13a side makes it possible to easily read the information held by the information holding unit 11 on the radiopharmaceutical manufacturing system 1 side.

In addition, the radiopharmaceutical manufacturing system 1 according to the present embodiment includes a determination unit 6 and a warning unit 7. The determination unit 6 determines the number of times of use of the kit 10 and determines whether the number of times of use exceeds the predetermined number of times. When the number of uses exceeds a predetermined number, the warning unit 7 issues a warning. Therefore, if the operator intends to use the sleeve assembly 10 more than a predetermined number of times, a warning based on a display or a sound is issued by the warning section 7, and the operator can detect that the predetermined number of times has been exceeded. In addition, even when the operator intends to use the cover assembly 10 exceeding a predetermined number of times intentionally, it is possible to prevent the use exceeding the predetermined number of times by implementing measures such as locking by the warning section 7. Therefore, it is possible to eliminate the time and effort for the operator to grasp the number of uses of the cover assembly 10, and it is possible to reliably avoid using the cover assembly 10 exceeding a predetermined number of times.

In addition, according to the radiopharmaceutical manufacturing system 1 according to this embodiment, the radiopharmaceutical corresponding to the kit 10 is discriminated by the discriminating unit 6, and the control unit 8 performs control corresponding to the discriminated radiopharmaceutical. Therefore, for example, when the type of the radiopharmaceutical determined by the discriminating unit 6 is the radiopharmaceutical A, the control unit 8 automatically executes a procedure for manufacturing the radiopharmaceutical A, or can be notified when an operator incorrectly sets an operation. Therefore, the operator can produce a desired radiopharmaceutical without the need for labor when selecting a kit and corresponding operation setting.

In addition, according to the radiopharmaceutical manufacturing system 1 of the present embodiment, the determination unit 6 determines the life of the kit 10 and determines whether the life has expired. And when the expiration date is exceeded, the warning section 7 issues a warning. Therefore, if the operator intends to use the kit 10 that has exceeded the predetermined use period, the warning section 7 issues a warning based on display or sound, and the operator can detect that the kit 10 has exceeded the use period. In addition, when the operator intends to use the kit 10 that has exceeded the use period intentionally, it is possible to reliably avoid using the kit that has exceeded the use period by implementing measures such as locking by the warning section 7. Therefore, it is possible to eliminate the time and effort required for the operator to grasp the lifespan of the cover assembly 10, and it is possible to reliably avoid using the cover assembly 10 that has exceeded the lifespan.

In addition, according to the radiopharmaceutical manufacturing system 1 of this embodiment, the information storage unit 9 is the identification information held by the information holding unit 11 of the memory case assembly 10 or the usage state of the case assembly 10 corresponding to the identification information. For example, the information processing unit 3 preferably keeps the usage state in the information storage unit 9, and then sends it to the server 100, and the information holding unit 11 in the writing unit 10 is preferable. Thereby, it is possible to obtain a record table about the usage patterns of the package 10 corresponding to the identification information. Therefore, information such as the past usage patterns of the management kit 10 can be coordinated in a form that is associated with the identification information, and the operator or manager can easily refer to and use the information. For example, in the case where the kit 10 was used in the past, referring to the record table, it is possible to know in what manner the kit has been used in the past. When the radiopharmaceutical production system 1 cannot normally produce a radiopharmaceutical, etc., the reason can be understood by referring to this record sheet. Therefore, it is possible to further The ease of use of the cover assembly 10 and the radiopharmaceutical manufacturing system 1 is improved.

The kit for a radiopharmaceutical manufacturing system and the radiopharmaceutical manufacturing system of the present invention are not limited to those described in this embodiment. For example, the shape, size, or piping configuration of the substrate may be appropriately changed in the cover assembly 10.

In addition, the determination unit 6 may determine whether the package 10 is a defective product or a counterfeit product (for example, a counterfeit product) based on the identification information. The warning unit 7 may also issue a warning based on the determination result.

1‧‧‧ Radiopharmaceutical Manufacturing System

2‧‧‧ processing unit

3‧‧‧ Information Processing Department

4‧‧‧ fixed section

5‧‧‧ Information Reading Department

6‧‧‧Discrimination Department

7‧‧‧Warning Department

8‧‧‧Control Department

9‧‧‧ Information and Memory Department

10‧‧‧sets

10A‧‧‧set of components

10B‧‧‧set of components

11‧‧‧ Information Retention Department

100‧‧‧Server

Claims (3)

A kit for a radiopharmaceutical manufacturing system is a radiopharmaceutical manufacturing system suitable for manufacturing radiopharmaceuticals in a replaceable manner. The kit is characterized in that the aforementioned kit can be used within a predetermined number of times and has: a substrate; A piping mounted on the substrate; and an information holding unit that holds information on the number of uses of the radiopharmaceutical manufacturing system cover assembly in the radiopharmaceutical manufacturing system. The piping is mounted on the surface side of the substrate, and the information is held. The IC module is mounted on the back side of the substrate, and the information holding unit is an IC chip that writes new usage frequency information each time the kit is used. A radiopharmaceutical manufacturing system, comprising: a fixing unit capable of fixing the radiopharmaceutical manufacturing system cover assembly described in the first patent application scope in a removable manner; and information for reading the information held by the IC chip. Reading department. The radiopharmaceutical manufacturing system according to item 2 of the scope of patent application, further comprising: a first determination unit that judges the number of uses of the kit for the radiopharmaceutical manufacturing system based on the use frequency information held by the IC chip; and The first warning section issues a warning when the number of uses determined by the first determining section exceeds a predetermined number of uses.