JP2008225531A - Cell preparation management method and system for use during cell preparation - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a cell preparation management method and system that prevent risks to living bodies by precisely managing, without mistakes, raw materials including resources such as an enormous number of containers that are handled during cell preparation. <P>SOLUTION: When cell preparation is performed in an aseptic operation area using raw materials including biologically derived raw materials and resources associated with samples, cell preparation instruction information associated with identification information such as raw material identification information and resource identification information is stored in an information processor. A wireless reader reads identification information provided to a wireless communication device attached to the raw materials conveyed into and out of the aseptic operation area. The information processor collates the read identification information with the corresponding identification information associated with the cell preparation instruction information, and outputs collation information indicating whether or not they match. When it is confirmed that the collation information indicates their match, the cell preparation is continued. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention uses, for example, a safety cabinet using raw materials including biological materials such as cells and culture media associated with specific specimens such as humans and animals, and containers and chemicals such as dishes and centrifuge tubes. The present invention relates to a cell preparation management method and a cell preparation management system when cells are prepared in an aseptic operation area. More specifically, the identification information carried in a wireless communication device such as an IC tag mounted on the material in association with the raw material or the material, and a wireless reader such as a reader that reads the information are communicably connected. Corresponding cell preparation instruction information stored in advance in the information processing apparatus associated with the information processing apparatus is collated by the information processing apparatus operated by a computer, and whether or not they match is output as collation information. A cell preparation management method and a cell preparation management method in which a cell preparation operator can strictly execute cell preparation in accordance with a necessary procedure in an aseptic operation area while checking the output collation information. About the system.

  In recent therapeutic medicine, research on so-called regenerative medicine, in which cells collected from a living body are cultured to regenerate lost living tissue, has been actively conducted. Accordingly, in order to culture the cells associated with at least one specimen to the amount of cells necessary for treatment, for example, cell preparation work including at least several replacement of the container by cell preparation such as passage is performed. In some cases, a material such as a container of about 100 to 300 or more and various kinds of plural medicines are used. At that time, it is needless to say that a strict work procedure is required such as eliminating cross contamination between containers and chambers and preventing human error (for example, see Patent Document 1). In addition, the process of obtaining the required cell volume by cell culture after cell preparation is different from the case of manufacturing industrial products and foods, and the history of each cell must always be handled strictly from the management aspect (for example, non-patent literature). 1). Therefore, cell preparation such as medium exchange, centrifugation, and subculture is usually performed in accordance with the standard operating procedure called SOP (Standard Operating Procedure) in a facility that complies with the GMP (Good Manufacturing Practice) standard of the investigational drug. Is recommended (see, for example, Non-Patent Document 2).

  According to Patent Document 1, in order to proliferate to a certain number of cells in cell culture, it is usually necessary to subculture the cells. When such subculture is performed, the medium in the container is replaced or subcultured. It is described that complicated cell preparation such as reseeding of cells into a new medium for subculture is performed manually. In addition, cell preparation accompanying these subcultures needs to be performed by skilled workers in order to suppress the occurrence of cross-contamination between multiple containers or between rooms, in order to improve such workability. Describes a device for managing containers to be cultivated while having identification information such as barcodes attached to the containers to be cultured. In Non-Patent Document 1, the growth of cells associated with individual specimens is uneven, and depending on the growth, container replacement and culture processes for grouping cells into multiple groups during the manufacturing process are monitored. Includes a non-flow work process including a so-called deviation process such as a manufacturing process. Non-Patent Document 2 states, “In this case, the hardware (cell processing facility) is naturally planned, designed and constructed based on the investigational drug GMP, and validation is performed at the same time. “Quality control) is also obliged to create an SOP”.

JP 2004-16194 A Japanese Patent No. 3706128 "Kinetic Evaluation and Bioprocess Design Considering Heterogeneity of Human Tissue Culture" Osaka Univ., Fundamental Engineering ○ (Ful) Kinooka Masahiro, (Ful) Taya Masahito (August 12, 2003 Chemical Society of Japan) Autumn Meeting Research Presentation Lecture) “Air Conditioning Equipment and Plant System” (no.11 Hitachi Plant Technical Journal 2005. December), pages 10-11

  By the way, almost all of the cell preparation steps are performed in a safety cabinet in which an aseptic operation area is formed, a work table for cell preparation, and the like while strictly following each work step in accordance with necessary procedures. For this reason, in cell preparation consisting of at least several steps, raw materials such as raw materials and materials necessary for each step are brought into an aseptic operation area to prepare cells, and the useful materials and wastes that store the raw materials after cell preparation For example, if the useful items are stored frozen, the useful items are carried out to an area such as a storage room in which the freezer is arranged. On the other hand, the disposable waste is carried out, for example, to a waste chamber disposed near the aseptic operation area. Then, the necessary raw materials are again brought into the aseptic operation area, and the next process is repeated. Therefore, in cell preparation consisting of at least several steps, the types and quantities of raw materials including materials such as containers and medicines repeatedly brought into the aseptic operation area reach a huge number. Further, materials such as containers used for cell preparation are often disposable from the viewpoint of preventing cross contamination, and the number and types of such waste materials are enormous.

For example, the bone marrow of a few cc were collected in an undifferentiated state from one patient, a 10 ³ to 10 MSCs amount between about ⁴ contained therein grown to cell mass of about 10 ⁷ to 10 ^8, There is a regenerative medical technique that administers and treats the patient (for example, see Patent Document 2).
FIG. 8 is a typical schematic diagram of raw material management including materials such as dishes and centrifuge tubes that are required when culturing cells derived from the person used for such regenerative medicine. Including the step of creating a medium using peripheral blood for autologous serum used for cell growth by culture, the amount of material required per person is, for example, 300 dishes or more and about 250 centrifuge tubes. It is clear that it is not an odd quantity. The device described in Patent Document 1 can meet the minimum needs for prevention of mix-up and cross-contamination by confirming culture procedures and conditions associated with primary and subcultured cells. It is not supposed to manage such a huge number of various materials accurately and without mistakes, and there is a limit to the management. Furthermore, after cell preparation, the work of sorting raw materials into useful and waste becomes complicated, making it easy for mistakes to mix useful and waste, and sometimes disposable materials are judged useful and reused. This may cause a cross-contamination accident that should not occur.

  The present invention has been made in view of such circumstances, and by accurately managing raw materials including materials such as a vast number of containers and drugs that are handled in cell preparation in an aseptic operation area, a living body can be managed. It is an object of the present invention to provide a cell preparation management method and a cell preparation management system that can avoid the danger of giving.

  In order to achieve the object, the invention described in claim 1 includes a raw material including a raw material derived from a living organism such as a cell or a medium associated with a specific specimen and a material such as a container such as a dish or a centrifuge tube, or a medicine. When preparing cells in an aseptic operation area, cell preparation at least associated with each of identification information such as raw material identification information for identifying the raw material, process identification information for identifying the cell preparation process, and material identification information for identifying the material Wireless communication in which instruction information is stored in advance in an information processing apparatus that is caused to function by a computer and connected to the apparatus so as to be communicable is mounted on the raw material to be carried into the aseptic operation area or the raw material to be carried out The identification information previously carried by the apparatus is read, and the information processing apparatus reads the identification information thus read and the corresponding identification information associated with the cell preparation instruction information. The cell information is output as the collation information, and the cell preparation is continued when the collation information is confirmed by the operator who prepares the cells. And a cell preparation management method when cells are prepared using raw materials in an aseptic operation area.

According to the second aspect of the present invention, there is provided an aseptic operation zone in which a raw material including a biological material such as a cell or a medium used for cell preparation and a material such as a container such as a dish or a centrifuge tube or a drug is prepared by a cell preparation operator A cell preparation management method for carrying out cell preparation using raw materials in an aseptic operation area that is carried into a wireless communication device preliminarily having identification information for uniquely identifying the raw materials attached to the raw materials. A step of preliminarily storing cell preparation instruction information associated with at least the identification information in an information processing device to be carried by a computer; and a wireless reader connected to the information processing device in a communicable manner, Reading the identification information of the raw material carried into the aseptic operation area;
The information processing device collates the read identification information with the corresponding identification information associated with the cell preparation instruction information, and outputs a determination result as to whether or not they match as collation information And including
When the output collation information is collation information indicating coincidence, the raw material is continuously carried into the aseptic operation area, and when the collation information output is collation information indicating mismatch, the aseptic operation area A method of carrying out error handling by interrupting the delivery of the raw material to

  In addition to the features of the invention described in claim 2, the invention described in claim 3 is the aseptic operation area by the operator after the introduction of the raw material to the aseptic operation area is interrupted and error handling is performed. It is characterized in that the introduction of the raw materials to the is resumed.

  According to a fourth aspect of the present invention, in addition to the features of the second or third aspect of the invention, the information processing device displays the output collation information on a display means provided in the aseptic operation area. The method further includes a step.

  The invention according to claim 5 is an operation in which a raw material containing a biological material such as a cell or a medium used for cell preparation in a sterile operation area and a material such as a container such as a dish or a centrifuge tube or a medicine is used for cell preparation A cell preparation management method for preparing cells using raw materials in an aseptic operation area, which is sorted by a person into a waste raw material such as a disposable container and a transport raw material in a raw material holding state and is transported from the aseptic operation area. The wireless communication device mounted on the raw material has in advance identification information for uniquely identifying the raw material, and an information processing device that is caused to function by a computer, at least associated with the identification information, Pre-store cell preparation instruction information incorporating waste raw material information identifying whether the raw material is the waste raw material or the transport raw material; A wireless reader communicatively connected to the information processing device reads the identification information of the raw material when the raw material is carried into the aseptic operation area; and the information processing device is read And comparing the corresponding identification information associated with the cell preparation instruction information and outputting a determination result as to whether or not the two coincide with each other. When the verification information is verification information indicating a match, first, the raw material is carried into the aseptic operation area, and then the raw material that is unloaded from the aseptic operation area after cell preparation is performed The raw material to the aseptic operation area is selected when it is selected as either a waste raw material or the transport raw material, and the outputted verification information is verification information indicating a mismatch. Carried is interrupted, characterized in that as an error process is performed.

  According to a sixth aspect of the present invention, in addition to the features of the fifth aspect of the present invention, after the carrying of the raw material into the aseptic operation area is interrupted and error handling is performed, the raw material is processed by the operator. The delivery to the aseptic operation area is resumed.

In addition to the features of the invention described in claim 5 or 6, the invention described in claim 7
When the raw material is unloaded from the aseptic operation area after cell preparation is performed, the wireless reader reads the identification information again, and the information processing device reads the identification information and the cell A step of outputting a determination result obtained by collating the corresponding identification information associated with the preparation instruction information as second collation information, and based on the output second collation information, the operation According to the present invention, the raw material is selected as either the waste raw material or the transport raw material.

In addition to the features of the invention according to any one of claims 5 to 7, the invention according to claim 8
The information processing apparatus further includes a step of displaying the output collation information and / or the second collation information on a display unit provided in the aseptic operation area.

  According to a ninth aspect of the present invention, in addition to the feature of the fourth aspect of the present invention, the waste raw material is communicatively connected to the information processing apparatus after being discharged from the aseptic operation area. The second wireless reader reads the identification information of the wireless communication device mounted on the waste raw material when transported to a waste room via a pass box equipped with a wireless reader, The information processing apparatus collates the read identification information with the corresponding identification information associated with the cell preparation instruction information in which the discard instruction information is incorporated, and determines whether or not they match Is output as second verification information, and when the second verification information output by the operator is verification information indicating coincidence, the waste raw material from the aseptic operation area to the disposal chamber is output. Conveyance continues In the case where the second verification information is verification information indicating a mismatch, the transport of the waste raw material from the aseptic operation area to the disposal chamber is interrupted and error processing is performed. And

  In addition to the features of the invention according to claim 9, the invention according to claim 10 is characterized in that after the conveyance of the waste raw material from the aseptic operation area to the waste chamber is interrupted and error handling is performed, According to the present invention, the transport of the waste raw material from the aseptic operation area to the waste chamber is resumed by the operator.

  According to an eleventh aspect of the invention, in addition to the features of the invention according to the ninth or tenth aspect, the information processing apparatus is equipped with the output second verification information in the aseptic operation area. It is custom-made that it further includes a step of displaying on the display means.

  The invention described in claim 12 is a cell preparation management when cell preparation is performed using raw materials including biological materials such as cells and culture media to be prepared, containers such as dishes and centrifuge tubes, and materials such as drugs. The system is a sterile operation area in which a raw material equipped with a wireless communication device that preliminarily carries identification information for uniquely identifying the raw material is carried in and carried out after cell adjustment, and the wireless that is attached to the raw material An information processing device that is made to function by a computer and stores cell preparation instruction information that incorporates corresponding identification information associated with the identification information of the communication device, and the identification of the wireless communication device mounted on the raw material A wireless reading device communicably connected to the information processing device for reading information; the information processing device, the read identification information; Output corresponding to the identification information associated with the cell preparation instruction information and outputting a determination result as to whether or not the two match, the information processing apparatus output When the verification information is verification information indicating a match, the operator continues to carry in or carry out the raw material from the aseptic operation area, and the output verification information indicates a mismatch. In this case, the carrying-in or carrying-out of the raw material from the aseptic operation area is interrupted, and error processing is performed.

  In addition to the features of the invention described in claim 12, the invention described in claim 13 includes the cell preparation instruction information stored in advance in the information processing apparatus, wherein the raw material is a waste raw material such as a disposable container or a raw material. It is characterized by incorporating waste raw material information for identifying whether the raw material is held.

  The invention described in claim 14 is characterized in that, in addition to the features of the invention described in claim 12 or 13, the information processing apparatus is provided in the aseptic operation area.

  According to a fifteenth aspect of the present invention, in addition to the features of the invention according to any one of the twelfth to fourteenth aspects, the information processing apparatus provides display means for displaying the output collation information in the aseptic operation area. It is characterized by being equipped.

  In addition to the features of the invention according to any one of claims 13 to 15, the invention described in claim 16 further includes a waste chamber in which the waste raw materials discharged from the aseptic operation area are discarded. It is characterized by that.

  According to a seventeenth aspect of the present invention, in addition to the feature of the sixteenth aspect, when the waste raw material discharged from the aseptic operation area is transported to the waste chamber, the waste raw material is routed. The pass box is further included.

  According to an eighteenth aspect of the present invention, in addition to the features of the seventeenth aspect of the invention, the pass box reads the identification information carried in advance in the wireless communication device mounted on the waste raw material. The wireless reading apparatus further communicably connected to the information processing apparatus is further provided.

  By the way, the aseptic operation area in which cells are prepared in the present invention includes, for example, a safety cabinet having an insertion port for taking in and out raw materials used for cell preparation and a storage section for handling the inserted raw materials, as shown in the examples, and the insertion thereof. And an operation desk equipped with a wireless reading device such as a reader, a wireless antenna, a display touch panel, and the like, which are provided near the mouth. Alternatively, the aseptic operation area of the present invention is a cell preparation work table that is arranged in a cell preparation room and is managed in a sterile state, and a cell that is remotely operated by a manipulator with an operation desk arranged outside. The preparation chamber itself can also be included. In any case, identification information such as an ID number carried in advance in a wireless communication device such as an IC tag attached to a raw material to be carried in and out is read by a wireless reader such as a reader, and the read identification information and It is desirable to be an aseptic operation area where each operation can be reliably performed while collating with identification information associated with stored cell preparation instruction information including, for example, instructions. Furthermore, the cell preparation instruction information includes at least identification of the raw material to ensure that the raw material transported from the aseptic operation area after the completion of one-step cell preparation is sorted into the raw material to be discarded and the raw material to be stored. It is desirable to store in advance discard instruction information associated with the information.

FIG. 1 is an outline of a procedure for performing cell preparation using the cell preparation management system according to the present invention and an image diagram of the entire system.
In the case of FIG. 8, a sample of a patient (donor) for cell preparation is collected in a hospital, and the sample is transferred to a GMP-compliant cell processing facility (Cell Processing Center = CPC). ) In accordance with the respective procedures such as culture acceptance, cell preparation, culture, storage and shipment, and the processed specimen is delivered from the cell processing facility to the hospital and administered to the donor patient. These procedures are preferably compliant with SOP, for example. FIG. 2 shows an example of a specific procedure performed in the procedure. In the example shown in FIG. 2, a sample ID number is created at the sample collection stage prior to cell preparation and culture, and cell preparation instruction information including instructions associated with the sample ID number is created at the culture acceptance stage. In the cell preparation / culture stage, when such instructions are executed, identification information to be carried on the IC tag attached to the raw material and the raw material including the material is created. As will be described later, the instructions are data for indicating information relating to raw materials necessary for each step of cell preparation, work contents performed in the steps, and the like.

  FIG. 3 shows an example of a cube-type cell processing facility (CPC) 100 in which the system according to the present invention is implemented. FIG. 3 shows the movement of a person passing through a clothing / undressing room, the movement of raw materials via a pass box, and the movement of waste discarded after the procedure according to the procedure. The cell processing facility 100 includes a storage room 120, a preparation room 130, and important devices (301 to 306) used when performing the procedure and slave units (201 to 203) that are information terminals of the system, A cell preparation culture room 140 and a management room 110 provided with at least a master unit 204 which is an information processing apparatus for managing the entire system are provided. Typically, the present invention is a cell preparation management method performed in the biohazard safety cabinet 303 arranged in the cell preparation culture chamber 140 of FIG. 3, and is a cell preparation management system therefor.

FIG. 4 is a perspective view showing an embodiment of a safety cabinet, for example, corresponding to the biohazard countermeasure cabinet 303 shown in FIG. 3 used in cell preparation according to the present invention. The safety cabinet 303 has, for example, a cubic shape, and the inside of the safety cabinet 303 includes such raw materials in addition to biological materials stored in the raw material container 321 such as cells and culture media associated with a donor specimen used for cell preparation. A container 314 for preparing cells using a container such as a dish 320 or a centrifuge tube 322 or a material such as a medicine 323.
These raw materials and materials are collectively called raw materials.

  An opening / closing shutter may be provided on the front surface of the safety cabinet 303. When a shutter is provided, the insertion port 316 is formed so that raw materials can be taken in and out by opening and closing the shutter. FIG. 4 shows a situation where some materials such as dishes and centrifuge tubes necessary for cell preparation have already been brought in. The centrifuge tube 322 is used when, for example, purification and separation are performed by a centrifuge 304 disposed in the vicinity of the safety cabinet 303 of FIG. Further, in the cell preparation culture chamber 140 of FIG. 3, when discarding the discarded materials such as the incubator 306 used for the primary culture and the subculture and the used raw material container 321 after the cell preparation, the materials were carried on the materials. A waste room or a waste chamber 305 equipped with a reader for reading the ID number may be provided. When cells are prepared using the safety cabinet 303 in such a cell preparation culture chamber 140, the operator 318 who prepares the cells performs necessary work in accordance with the procedure while visually recognizing the storage unit 314. For example, when a necessary raw material is brought into the storage portion 314, the operator 318 brings the raw materials one by one or a plurality of raw materials from the insertion port 316. An IC tag 324 is attached to each raw material, and an IC chip constituting the IC tag carries an ID number for identifying the raw material. Typically, an operation including a reader 325 for reading an ID number carried on an IC tag, a reader antenna 326, a display touch panel 328, and the like in the vicinity of the insertion slot 316 of the safety cabinet 303 used here. A desk 327 is arranged. The operation desk 327 has the function of the information terminal (child device) 203 in FIG. 3 and is connected to the information processing device (parent device) 204 so as to be communicable.

  The ID number carried on the IC tag attached to the raw material each time each of the raw materials brought into the accommodating portion 314 of the safety cabinet 303 from the insertion port 316 by the operator 318 who prepares cells passes through the operation desk 327. Is reliably detected by the antenna 326 and read by the reader 325. The reader 325 may be integrated with the information terminal 203 in FIG. As described above, each of the information terminals (201 to 203) is communicably connected to the information processing apparatus (master unit) 204 in the management room, and the information processing apparatus 204 is caused to function by a computer. On the other hand, cell preparation instruction information including instructions, which is associated with the ID number to be compared with the ID number read by the reader 325, is created in advance as described in detail below. Stored in advance.

  The information processing apparatus 204 of the cell processing facility 100 includes a database server in which applications are stored, an application server that executes applications, and a web server that has a communication function. 203). These information terminals (201 to 203) have an input / output function, and can also have an input function for writing data to an IC tag. The database includes one-to-many correspondence with sample data, one-to-one correspondence with the sample data, a plurality of instruction data with one-to-many correspondence with the process data, and each of the plurality of instruction data. A plurality of raw material data are stored. That is, one process data is associated with one specimen data, a plurality of instruction data is associated with one process data, and a plurality of raw material data is associated with each of the plurality of instruction data. The database also includes commonly used master data, for example, worker information such as people, departments, occupations, etc., original order information, process information as process creation rules, raw material information, inspection information, and equipment Stores device information and holiday information necessary for scheduling.

  The application stored in the database has a specimen information management function, a process management function, an instruction management function, a raw material management function, an ID collation function, and a master management function. The sample function issues a unique sample ID number for distinguishing from other samples in the system and manages it together with sample information. In the culture acceptance stage shown in FIG. 2, when and who schedules what sample and what work. Next, the process management function creates sample-specific process data, instruction data, and raw material data. Since these data are associated with the unique specimen ID number, it is possible to discriminate from the system side all the raw materials to which the ID number is assigned. The process management function further manages the progress of the process for cell preparation. The instruction management function instructs what kind of work is to be performed in which sample, and records the suitability of the work result, the actual quantity, and the like. The raw material management function manages how much raw material is required for which work of which specimen. The ID collation function collates the raw material ID number stored in advance designated by the raw material management function with the ID number input by the ID input function. The master management function stores, changes, and holds master data.

  One embodiment of the present invention will be described based on an image diagram of raw material management in FIG. 5 and a flowchart showing management and work procedures in FIG.

In the image diagram of FIG. 1 (acceptance) to No. 1 A set of instructions up to 8 (administration) is process data created based on the process creation rules.
The process data is configured by arranging instructions along a time axis as to when and which work to perform. Instructions combined as process data are stored in the master data of the database, and various combinations can be selected for the instruction set according to the type, age, sex, etc. of the specimen. ing. In accordance with each instruction, information from (1) raw materials to be used to (5) waste is specifically created for each donor specimen, and is stored in advance in a database of the information processing device 204, for example. Stored.

An example of an instruction that specifically shows the contents is indicated by an instruction number. FIG.
The instructions include the safety cabinet number, work date and time, operator name, cell information (cell type, provider name, collection date, etc.), work contents, and the ID list of the imported raw materials. Is displayed on the touch panel 328. For example, when the work content is passage processing, it is necessary to bring a dish in which cells are cultured as a cell transfer source from the incubator 306 to the safety cabinet 303, and the ID number of the dish specified for this purpose is designated. Displayed in books. In the subculture treatment, a predetermined culture solution is poured into a new empty dish to form a medium. Next, for example, the culture solution is removed from the dish of cultured cells, and the cultured cells are removed using chemicals or the like. After being transferred to a settling tube or the like and purified and separated by the centrifuge 304, the cultured cells are transferred to this medium. For these operations, in addition to a new dish and centrifuge tube, a pipette as a transfer tool is carried from the storage room 120 to the preparation room 130 and the cell preparation culture room 140 through the pass box. Therefore, the order number. In the No. 4 carry-in raw material list, the ID numbers assigned individually to these raw materials and materials are displayed. In addition, the instructions include a list of ID numbers of discarded raw materials that should be discarded after cell preparation. Cell preparation instruction information including a series of instructions created in this way is stored in advance in the information processing apparatus.

FIG. 5 is an image diagram of raw material management assuming that cells are prepared using a raw material to which an ID number is assigned. In FIG. 4 (1) The raw material to be used is, for example, a dish to which the ID number of the cultured cell taken out from the incubator 306 and brought into the safety cabinet 303 is given. The next (2) new material is a dish containing cultured cells to be transferred, and an ID number is not assigned at this stage. After the cultured cells are transferred to a new material, for example, a commercially available seal label printer that can output a label in a state associated with system information is prepared in advance. (3) The label to be used is a new one. Here, the ID number is assigned to the new material ((4) finished raw material). It is desirable that this label is equipped with an IC tag, and the information written on the IC tag can be visually recognized by the information printed on the surface. The last (5) waste is a material such as a used dish that is discarded when the cultured cells of the raw material used (1) are transferred to (2) a new material.
The operator 318 who prepares the cell performs work for each cell preparation while checking the ID number of the IC tag attached to the raw material and the corresponding ID number associated with the cell preparation instruction information on the touch panel 328. Can be implemented reliably.

Here, referring to the flowchart of FIG. 6, for example, a work procedure in the safety cabinet 303 will be described.
In S <b> 400, cell preparation instruction information including a pre-prepared instruction is stored in the information processing apparatus 204.
In S410, the operator 318 causes the necessary raw materials to pass through the operation desk 327 according to the cell preparation instruction information displayed on the touch panel 328.
In S <b> 420, the reader 325 of the operation desk 327 reads the ID number from the IC tag attached to the raw material brought into the safety cabinet 303 and transmits it to the information processing apparatus 204.
In S430, the information processing apparatus 204 collates the transmitted ID number with the corresponding ID number associated with the cell preparation instruction information stored in advance, and outputs whether or not they match as collation information. And displayed on the touch panel 328.
The operator 318 confirms the collation information, and if both are collation information indicating a mismatch, an error process is performed in S440. The collation information indicating inconsistency indicates that it is clear that the brought-in raw material is a raw material not included in the cell preparation instruction information. For this reason, the error processing is assumed to be, for example, to suspend the work, bring in the correct raw material, or to redo the work itself in a serious situation such as a different specimen ID.
After error processing, in S450, the operator 318 resumes S430 for the raw materials brought into the safety cabinet 303. If the two pieces of matching information indicate coincidence, in S460, the operator 318 continues the work of bringing the raw materials into the safety cabinet 303, and the raw material management information included in the cell preparation instruction information indicates whether the necessary raw materials are available. Confirm based on
In S470, if the necessary raw materials are not yet prepared, the operator 318 continues the work of bringing the raw materials into the safety cabinet 303.

In S480, the operator 318 performs cell preparation based on the work information included in the cell preparation instruction information when the necessary raw materials are prepared in the safety cabinet 303.
In S490, all the brought-in raw materials are carried out from the safety cabinet 303 after cell preparation. In order to check whether all the materials have been discharged, when the raw materials are discharged from the safety cabinet 303, the information is read again by the reader 325 through the operation desk 327 and the second verification information is output by the information processing device 204. It can also be.
In S500, based on the raw material management information included in the cell preparation instruction information, the operator 318 determines whether the raw material to be transported is a discarded raw material or a transport raw material temporarily stored in the incubator 306, the storage chamber 120, or the like. Sort into one.
In S510, when it is confirmed that the raw material to be carried out is a conveyance raw material, the operator 318 carries out the conveyance raw material to a target area.
When it is confirmed in S520 that the raw material to be carried out is a waste raw material, the operator 318 sends the waste raw material into, for example, a pass box to the waste chamber 305, and the second reader equipped in the pass box. Reads the ID number of the IC tag attached to the discarded raw material and transmits it to the information processing apparatus 204. Next, the information processing apparatus 204 collates the transmitted ID number with the corresponding ID number associated with the cell preparation instruction information stored in advance, and outputs whether or not the two coincide with each other. And displayed on the touch panel 328.
In S530, the operator 318 confirms the collation information, and if both are collation information indicating a mismatch, an error process is performed. In this case, the collation information indicating mismatch indicates that the brought-in raw material is not a discarded raw material, and it is confirmed whether or not it is a transported raw material and transported to a necessary area, for example. This is error handling.
If the two pieces of matching information indicate matching, in S540, the operator 318 continues the disposal work of the discarded raw materials in the disposal chamber 305, and the operator 318 confirms that all of the raw material carry-out work has been completed in S550. Confirm.
Next, in S560, it is confirmed based on the raw material management information included in the cell preparation instruction information whether all of the raw materials have been discharged. If unfinished, the operator 318 continues to carry out the raw materials. Otherwise, the operator 318 ends the carry-out work.

  As described above, according to the present system and method, all the raw materials brought into the aseptic operation area such as the safety cabinet 303 of the present embodiment are equipped with the reader 325 that is communicably connected to the information processing apparatus 204, for example. By passing through the operation desk 327, the reader 325 reads the ID number previously carried on the IC tag attached to the raw material, and transmits it to the information processing apparatus 204. The information processing device 204 compares the read ID number with the corresponding ID number associated with the cell processing instruction information stored in advance in the information processing device 204, and determines whether or not they match. Output as. Therefore, the operator 318 in charge of cell preparation can surely perform each operation while checking the collation information output in this way on the touch panel 328 one by one. Needless to say, according to the present system and method, it is possible to reliably prevent accidents related to human life, such as the mistake of cell providers and cultured cells. Furthermore, according to the present system and method, raw materials derived from living organisms such as cells and culture media associated with specific specimens used for cell preparation performed for growing specimen cells to the required cell volume, dishes, Closely manage raw materials of enormous quantities, including containers such as centrifuge tubes and materials such as chemicals, prepared culture fluids and various types of chemicals, and carry out them without any individual work. Can do it.

It is an image figure of system operation of the cell preparation management system concerning the present invention. It is an example of an item of each process in system operation of a cell preparation management system concerning the present invention. It is the schematic of the cell processing facility containing the cell preparation culture room of the cell preparation management system which concerns on this invention. It is a schematic diagram which shows the cell preparation management state by the operator who prepares a cell in the aseptic operation area of the cell preparation management system which concerns on this invention. It is a raw material management image figure of the cell preparation management system which concerns on this invention. It is a work procedure flowchart of the cell preparation management system which concerns on this invention. It is an example (instruction No. 4) included in the cell preparation instruction information of the cell preparation management system according to the present invention. It is an example of the quantity of the raw material required for the cell preparation per person in the cell preparation management system which concerns on this invention.

Explanation of symbols

100 Cell Processing Facility 110 Management Room 120 Storage Room 130 Preparation Room 140 Cell Preparation Culture Room 201-203 Information Terminal (Slave Unit)
204 Information processing device (base unit)
303 Biohazard safety cabinet 304 Centrifuge 305 Waste room or waste chamber 306 Incubator
314 Safety cabinet storage 316 Safety cabinet insertion slot 318 Cell preparation operator 320 New empty dish 321 Raw material stored dish 322 Centrifuge tube 323 Medicine 324 IC tag 325 reader 326 antenna 327 operation Desk 328 Touch panel such as display means equipped with operation desk

Claims (18)

  Identify raw materials when preparing cells in a sterile operating area using raw materials such as cells and culture media associated with a unique specimen and raw materials including materials such as dishes and containers such as dishes and centrifuge tubes. Cell preparation instruction information associated with at least each of identification information such as raw material identification information, process identification information for identifying a cell preparation process, and material identification information for identifying the material is stored in advance in an information processing apparatus that is caused to function by a computer And the wireless reader connected to the apparatus so as to be communicable reads the identification information previously carried by the wireless communication apparatus mounted on the raw material carried into the aseptic operation area or the raw material carried out, and the information processing The apparatus collates the read identification information with the corresponding identification information associated with the cell preparation instruction information, and whether or not they match Using the raw material in the aseptic operation area, wherein the cell preparation is continued when it is confirmed that the collation information is matched by the operator who prepares the cell. Cell preparation management method when preparing cells. In the aseptic operation area, raw materials such as cells and culture media used for cell preparation and raw materials including materials such as dishes and containers such as centrifuge tubes and chemicals are brought into the aseptic operation area by the cell preparation operator. A cell preparation management method for preparing cells using raw materials,
Preliminarily carrying identification information for uniquely identifying the raw material in a wireless communication device attached to the raw material;
Pre-stores at least cell preparation instruction information associated with the identification information in an information processing apparatus that is caused to function by a computer;
A wireless reader connected to the information processing device in a communicable manner, reading the identification information of the raw material carried into the aseptic operation area;
The information processing device collates the read identification information with the corresponding identification information associated with the cell preparation instruction information, and outputs a determination result as to whether or not they match as collation information When,
Including
When the output verification information is verification information indicating coincidence, the raw material is continuously carried into the aseptic operation area, and when the output verification information is verification information indicating mismatch, A method of carrying out error handling by interrupting the delivery of the raw material to the operation area.   The delivery of the raw material to the aseptic operation area is resumed by the operator after the delivery of the raw material to the aseptic operation area is interrupted and error handling is performed. Method.   The method according to claim 2, further comprising the step of the information processing apparatus displaying the output collation information on a display unit provided in the aseptic operation area. The raw materials, including biological materials such as cells and culture media used for cell preparation in the sterile operation area, and containers such as dishes and centrifuge tubes, and materials such as chemicals, are discarded raw materials such as disposable containers by the operator who prepares the cells. A cell preparation management method when cell preparation is performed using raw materials in an aseptic operation area, which is sorted into a raw material-carrying transport raw material and transported from the aseptic operation area,
Preliminarily carrying identification information for uniquely identifying the raw material in a wireless communication device attached to the raw material;
A step of preliminarily storing cell preparation instruction information incorporating waste raw material information, which is associated with at least the identification information and identifies whether the raw material is the waste raw material or the transport raw material, in an information processing apparatus that is caused to function by a computer When,
A wireless reader connected to the information processing device in a communicable manner, when the raw material is carried into the aseptic operation area, reading the identification information of the raw material;
The information processing apparatus collates the read identification information with the corresponding identification information related to the cell preparation instruction information, and outputs a determination result as to whether or not both coincide with each other. Steps,
Including
When the output collation information is collation information indicating coincidence, first, the raw material is carried into the aseptic operation area, and then the raw material is carried out from the aseptic operation area after cell preparation is performed. Is selected as either the waste raw material or the transport raw material, and the output of the verification information is verification information indicating a mismatch, the carry-in of the raw material to the aseptic operation area is performed. A method characterized in that it is interrupted and error handling is performed.   The method according to claim 5, wherein the loading of the raw material into the aseptic operation area is resumed by the operator after the loading of the raw material into the aseptic operation area is interrupted and error handling is performed. .   When the raw material is unloaded from the aseptic operation area after cell preparation is performed, the wireless reader reads the identification information again, and the information processing device reads the identification information and the cell A step of outputting a determination result obtained by collating the corresponding identification information associated with the preparation instruction information as second collation information, and based on the output second collation information, the operation 7. The method according to claim 5, wherein the raw material is sorted into either the waste raw material or the transport raw material.   The information processing device further includes a step of displaying the output collation information and / or the second collation information on a display unit provided in the aseptic operation area. the method of.   When the waste raw material is discharged from the aseptic operation area and then transferred to a waste room via a pass box equipped with a second wireless reader communicatively connected to the information processing device, The second wireless reading device reads the identification information of the wireless communication device attached to the discard raw material, and the information processing device incorporates the read identification information and the discard instruction information. The corresponding identification information associated with the cell preparation instruction information is collated, and the determination result as to whether or not the two match is output as second collation information, and the operator outputs the second output When the collation information is collation information indicating coincidence, the transport of the waste raw material from the aseptic operation area to the disposal chamber is continued, and when the second collation information is collation information indicating mismatch, in front Transport to the waste chamber of the waste raw material from the aseptic zone is interrupted, the method according to claim 4, characterized in that as an error process is performed.   After the transfer of the waste raw material from the aseptic operation area to the waste chamber is interrupted and error handling is performed, the operator can transfer the waste raw material from the aseptic operation area to the waste chamber. The method according to claim 9, wherein the method is resumed.   The method according to claim 9, further comprising the step of the information processing apparatus displaying the output second verification information on a display unit equipped in the aseptic operation area. A cell preparation management system for cell preparation using raw materials including biological materials such as cells and culture media to be prepared, containers such as dishes and centrifuge tubes, and materials such as drugs,
Aseptic operation area in which the raw material equipped with a wireless communication device preliminarily carrying identification information for uniquely identifying the raw material is carried in, and carried out after cell adjustment;
An information processing apparatus that is made to function by a computer, prestored with cell preparation instruction information that incorporates corresponding identification information associated with the identification information of the wireless communication device mounted on the raw material;
A wireless reading device communicably connected to the information processing device for reading the identification information of the wireless communication device mounted on the raw material;
The information processing apparatus collates the read identification information with the corresponding identification information associated with the cell preparation instruction information, and outputs a determination result as to whether or not they match as collation information Means,
Including
When the information processing apparatus is the collation information indicating that the collation information is coincident, the operator continues the carry-in or carry-out of the raw material from the aseptic operation area and has been outputted. A cell preparation management system characterized in that when the verification information is verification information indicating a mismatch, carrying-in or carrying-out of the raw material from the aseptic operation area is interrupted and error processing is performed.   13. The discarded material information for identifying whether the raw material is a discarded raw material such as a disposable container or a transported raw material in a raw material holding state is incorporated in the cell preparation instruction information stored in advance in the information processing apparatus. Cell preparation management system.   The cell preparation management system according to claim 12 or 13, wherein the information processing apparatus is equipped in the aseptic operation area.   The cell preparation management system according to any one of claims 12 to 14, wherein the information processing apparatus is equipped with display means for displaying the output collation information in the aseptic operation area.   The cell preparation management system according to any one of claims 13 to 15, further comprising a waste chamber in which the waste raw materials discharged from the aseptic operation area are discarded.   The cell preparation management system according to claim 16, further comprising a pass box for passing the waste raw material discharged from the aseptic operation area through the waste raw material when transported to the waste chamber.   The pass box is further equipped with a wireless reading device communicably connected to the information processing device for reading the identification information previously carried by the wireless communication device mounted on the waste raw material. The cell preparation management system according to claim 17.

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