Equipment and method for manufacturing goods using the same

Abstract

Provided are: a facility that can perform tasks efficiently while maintaining the cleanliness of a location where an article is to be manufactured, when executing manufacturing of the article and other tasks in parallel at the same time; and an implementation method for manufacturing the article using said facility.　The facility comprises: a clean room 1; a plurality of work booths 2 that are provided inside the clean room 1, and that have entrances and exits; and a barrier section that is provided along the entrances and exits of each of the plurality of work booths 2, and that blocks an air flow which flows through the entrances and the exits, from the outside to the inside. An area inside each of the plurality of work booths 2 has the same grade of cleanliness as an area that is inside the clean room 1 but is outside the plurality of task booths 2.

Description

[Technical field]

[0001] The present invention relates to an apparatus and a method for carrying out the manufacture of an article using the same. [Background technology]

[0002] Conventionally, a process simulation test has been conducted before starting the manufacture of an article (see, for example, Patent Document 1). A process simulation test is a test for verifying whether a manufacturing process or manufacturing method for an article such as a regenerative medicine product or a pharmaceutical product is appropriate for manufacturing the article. In a process simulation test, for example, the manufacturing procedure, equipment, materials, manufacturing environment, etc. are performed under the same conditions as in the actual manufacturing, and it is verified that the sterility expected for the product is ensured.

[0003] Therefore, in the process simulation test, it is necessary to take into consideration variable factors such as the personnel and equipment used in the actual manufacturing process of the article, and to repeatedly perform the process for all or each process. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2018-505669 Summary of the Invention [Problem to be solved by the invention]

[0005] However, when a process simulation test is performed in a clean room prior to the manufacture of an article, the actual manufacture cannot be started in the same clean room while the process simulation test is being performed, which is inefficient. Also, when multiple processes are performed, while one process is being performed, another process cannot be performed in parallel, which is inefficient.

[0006] Therefore, a process simulation test and the manufacture of an article are carried out in parallel at the same time using a plurality of clean rooms, or a plurality of manufacturing processes are carried out in parallel at the same time.

[0007] However, when multiple clean rooms are used, there is an increased possibility of contamination occurring inside the clean rooms when moving between clean rooms, for example, by airborne particles and / or microorganisms from less clean areas passing through when moving between clean rooms.

[0008] Furthermore, when workers move from outside the clean room (e.g., through a hallway) to inside the clean room, the cleanliness levels differ between the outside and inside of the clean room, so the workers must change into clothes appropriate to the cleanliness level each time, which is inefficient.

[0009] The present invention has been made in consideration of the above circumstances, and has an object to provide equipment that enables efficient operation while maintaining the cleanliness of the place where goods are manufactured when the manufacture of goods and other work are carried out simultaneously in parallel, and a method for manufacturing goods using the same. [Means for solving the problem]

[0010] According to one aspect of the present invention, there is provided a facility including a clean room, a plurality of work booths each having an entrance and a barrier section arranged along the entrance of each of the work booths and blocking an air flow passing through the entrance from outside to inside. An area inside each of the work booths and an area outside the work booths and inside the clean room have the same cleanliness grade.

[0011] A method for manufacturing an article according to one aspect of the present invention is a method for manufacturing an article using the above-described facility, in which the article is manufactured in at least one of the plurality of work booths, and a work other than the manufacture of the article is performed in another work booth among the plurality of work booths that is different from the work booth in which the article is manufactured. Effect of the Invention

[0012] The above-described equipment according to the present invention and the method for manufacturing an article using the same have the advantage that, when manufacturing an article and other work are carried out in parallel at the same time, the work can be carried out efficiently while maintaining the cleanliness of the place where the article is manufactured. [Brief description of the drawings]

[0013] [Figure 1] 1 is a schematic diagram of a facility according to an embodiment of the present invention; [Diagram 2] FIG. 2 is a diagram showing the cleanliness of the above-mentioned equipment. [Diagram 3] FIG. 2 is a perspective view of the work booth and support booth of the same. [Figure 4] 4 is a flowchart of a method for manufacturing the above-mentioned article. [Diagram 5] 2 is a process chart for manufacturing the above-mentioned article. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] (1) Implementation form (1.1) Overview A method for manufacturing an article according to this embodiment will now be described.

[0015] The method for manufacturing an article according to this embodiment (hereinafter sometimes referred to as the "manufacturing method") is carried out using equipment 8 including at least a clean room 1 and a number of work booths 2 provided within the clean room 1, as shown in FIG. 1.

[0016] The articles manufactured by the manufacturing method according to this embodiment include regenerative medicine products manufactured in a work booth 2 maintained at a high level of cleanliness. The term "regenerative medicine products" as used herein means (1) human or animal cells that have been subjected to processing such as culturing, and (a) products that are used to reconstruct, repair, or form the structure or function of the body, or (b) products that are used for the purpose of treating or preventing disease, or (2) products that are introduced into human cells for the purpose of gene therapy. The above (1) includes cell-processed products and tissue-processed products. Also, the above (2) includes gene therapy products and gene therapy drugs. Examples of human cell processed products include human somatic cell processed products, human somatic stem cell processed products, human embryonic stem cell processed products, and human induced pluripotent cell processed products. Examples of animal cell processed products include animal somatic cell processed products, animal somatic stem cell processed products, animal embryonic stem cell processed products, and animal induced pluripotent cell processed products. Examples of gene therapy products include, for example, plasmid vector products, viral vector products, and other gene expression therapy products. Specific examples of "regenerative medical products" include myocardial regeneration products, cartilage regeneration products, skin regeneration products, cells used in cancer immunotherapy (e.g., dendritic cells, NK cells, T lymphocytes, etc.), and products for treating genetic diseases.

[0017] However, the article according to the present invention is not limited to an article containing a regenerative medicine product, but may be an article containing, for example, a specific cell processed product, a pharmaceutical product, a processed food, etc. Examples of pharmaceutical products include anticancer agents, hemophilia treatment agents, biologics, plasma fraction preparations, vaccine preparations, companion diagnostics, and preparations for rare diseases.

[0018] When manufacturing the above-mentioned items, for example, it is required by ministerial ordinance and / or notification to conduct an appropriate number of (e.g., three) process simulation tests before starting manufacturing. For example, in the field of regenerative medicine products, the "Ministerial Ordinance on Standards for Manufacturing Management and Quality Control of Regenerative Medicine Products" ("GCTP Ministerial Ordinance") etc. require that process simulation tests be conducted before starting manufacturing.

[0019] In addition, process simulation tests must be performed for each manufacturing process not only before manufacturing begins, but also periodically (for example, at least once every six months), and must be performed by all workers involved in each manufacturing process. For this reason, an extremely large number of process simulations must be performed when manufacturing an item.

[0020] In process simulation tests, a microbial culture medium or the like is used in place of cells, culture fluids that come into direct contact with cells, chemical solutions, etc., and the suitability of the process for aseptic manipulation is evaluated by carrying out a manufacturing process under conditions similar to those for actual manufacturing, for example, procedures, equipment, raw materials, supplies, environment, personnel, etc., of the manufacture of an article.

[0021] Generally, when a process simulation test is performed, it is not possible to manufacture an article corresponding to the process simulation or to manufacture another article in parallel at the same time, because conventionally, when an article is manufactured in parallel at the same time as the process simulation, another clean room is required for the manufacture.

[0022] In contrast, the facility 8 according to this embodiment includes a clean room 1, a plurality of work booths 2 provided within the clean room 1, and a barrier section provided along the entrance / exit of each work booth 2. The barrier section has a function of impeding airflow passing through the entrance / exit from outside the work booth 2 to the inside. In the facility 8, the area inside the plurality of work booths 2 and the area outside the plurality of work booths 2 and inside the clean room 1 have the same grade of cleanliness.

[0023] Therefore, while an article is manufactured in at least one of the multiple work booths 2, other work (e.g., process simulation test) can be performed in parallel at the same time in one of the other work booths 2 that is not being used for the manufacture of the article. Moreover, even if contamination occurs in another work booth 2, it is possible to prevent contamination in the work booth 2 in which the article is being manufactured.

[0024] 2, the area inside the work booth 2 and the area outside the work booth 2 and inside the clean room 1 have the same cleanliness grade (Grade B in this case). Therefore, workers do not need to change into clothes according to the cleanliness grade when entering and leaving the work booth 2 or moving between work booths 2, and can work efficiently.

[0025] The "other work" referred to here means work other than the manufacture of an article using one work booth 2. Examples of the "other work" include a process simulation test carried out prior to the manufacture of the article, maintenance of equipment installed in another work booth, education and training of personnel involved in the manufacture of the article, manufacture of other articles other than the manufacture of the article in question, etc. Examples of the equipment installed in the work booth 2 include a centrifuge, a biohazard cabinet 25, an air inflow device 61 described below, etc.

[0026] In the following, first, the equipment 8 used in the manufacturing method of this embodiment will be described in detail, and then the method of manufacturing an article will be described.

[0027] (1.2) Equipment The facility 8 is for manufacturing articles and performing other operations (e.g., process simulation tests). As shown in FIG. 1, the facility 8 includes a clean room 1, which includes a plurality of (here, nine) work booths 2 and a plurality of barrier sections corresponding one-to-one to each work booth 2. As described above, the barrier sections are provided along the entrances and exits of the work booths 2, and have the function of blocking airflow passing through the entrances and exits from the outside of the work booths 2 to the inside. In this embodiment, the barrier sections are constituted by support booths 3. In addition to the work booths 2 and support booths 3, the clean room 1 is provided with passages 13 adjacent to each support booth 3.

[0028] (1.2.1) Clean Room The clean room 1 is a room in which the air inside is kept at a certain cleanliness level. The clean room 1 is composed of a room in a building, and the periphery is surrounded by an inner wall or a partition. The clean room 1 also has one or more entrances 11, 12, specifically, one entrance 11 and one exit 12. A dressing room 14 is provided outside the clean room 1 at a location leading to the entrance 11. The dressing room 14 is a room where workers change clothes when moving between the clean room 1 and the outside of the clean room 1. The cleanliness level inside the clean room 1 is set to "Grade B" as described later, while the cleanliness level outside the clean room 1 is set to "Grade C". Therefore, when moving between spaces with different cleanliness levels, it is necessary to change clothes in the dressing room 14.

[0029] Here, FIG. 2 shows cleanliness zones in the facility 8. The cleanliness grades shown in FIG. 2 are defined using the maximum allowable number of particles and the number of environmental microorganisms, as shown in Tables 1 and 2 below. In the facility 8 according to this embodiment, the inside of the work booth 2 and the outside of the work booth 2 and the inside of the clean room 1 (here, the passage 13 and the support booth 3) are set to the same cleanliness level "Grade B". However, "Grade B" may be distinguished from "Grade B" and "Grade B+" depending on the monitoring frequency. In this embodiment, the passage 13 is set to "Grade B", and the work booth 2 and the support booth 3 are set to "Grade B+". In addition, the biosafety cabinets 25 (BSC; Biosafety Cabinets) that handle items in the work booth 2 are set to "Grade A".

[0030] In the present invention, an area with a cleanliness level of Grade B (including Grade B+) may be referred to as a "cleanliness controlled area," and an area with a cleanliness level of Grade A may be referred to as an "area for aseptic operations, etc." In this way, by controlling the cleanliness level in the clean room 1 in the passages 13, the work booths 2, and the support booths 3 according to the type of work, contamination by airborne particles and microorganisms from outside is prevented.

[0031] Here, the "cleanliness controlled area" in the present invention refers to the area where work is performed, where item preparation work is performed and where containers, etc. before sterilization come into contact with the air in the equipment 8. Also, the "area for aseptic operation, etc." refers to the area where work is performed, where items, etc. that need to be handled using aseptic procedures are prepared, where sterilized containers, etc. come into contact with the air in the equipment 8, and where aseptic operations such as sterility tests are performed. [Table 1] [Table 2]

[0032] (1.2.2) Work booth The work booth 2 is provided in the clean room 1, and is a booth for mainly manufacturing products, and means a space partitioned off within the room. The work booth 2 is mainly used for manufacturing products, but when it is not used for manufacturing products, it may be used for process simulation tests, or / and equipment maintenance, or / and operator training.

[0033] As shown in FIG. 1, the facility 8 according to this embodiment includes nine work booths 2 as the multiple booths 2. Of the nine work booths 2, four work booths 2 (referred to as a first work booth group) are lined up in a first direction, and adjacent work booths 2 are adjacent to each other. In addition, four work booths 2 (referred to as a second work booth group) are provided in a direction perpendicular to the first direction (second direction) with respect to the first work booth group, with one work booth 2 (sometimes referred to as a "transfer area 7") in between. The four work booths 2 of the second work booth group are lined up in the first direction, and adjacent work booths 2 are adjacent to each other. Therefore, the transfer area 7 is accessible to all other work booths 2. Here, "access" means that items used in the manufacture of goods can be transferred.

[0034] In each work booth 2, equipment used in manufacturing an article is installed. Examples of the equipment include a workbench (not shown), a centrifuge (not shown), and a biohazard control cabinet 25. In this embodiment, as described above, the inside of the work booth 2 is a "cleanliness controlled area", but the inside of the biohazard control cabinet 25 is an "area for aseptic operations, etc." However, the "area for aseptic operations, etc." in terms of cleanliness does not have to be only the inside of the biohazard control cabinet 25; in addition to the inside of the biohazard control cabinet 25, for example, the top surface of the workbench may be the "area for aseptic operations, etc."

[0035] Here, Fig. 3 shows a schematic perspective view of the work booth 2 and the support booth 3. For convenience of explanation, Fig. 3 shows only one work booth 2 and one support booth 3, but in reality, a plurality of work booths 2 are lined up as shown in Fig. 1.

[0036] 3, the work booth 2 is partitioned by a front wall 21 (middle wall), a pair of side walls 22, a rear wall 23, and a top wall (top plate) 24 provided at the upper ends of these. A plurality of air inflow devices 61 serving as a positive pressure generating unit 6 are attached to the top wall 24. The air inflow devices 61 introduce air from inside the clean room 1 into the work booth 2, making it possible to maintain the inside of the work booth 2 at a positive pressure relative to the passage 13. The positive pressure generating unit 6 will be described in detail later in "(1.2.5) Positive Pressure Generating Unit".

[0037] In the present invention, by maintaining the work booth 2 in a positive pressure state, an airflow can be formed toward the support booth 3 through an entrance (first opening 4) formed in the front wall 21, and an airflow can be formed toward the passage 13 through an entrance (second opening 5) facing the passage 13 of the support booth 3. This makes it possible to prevent an airflow passing through the entrance from outside the work booth 2 to the inside, without blocking the entrance (first opening 4). In short, in this embodiment, the support booth 3 constitutes a barrier section.

[0038] The support booth 3 can prevent, for example, viruses, bacteria, mold, microorganisms, etc. (hereinafter referred to as "microorganisms, etc.") from entering the work booth 2 from the space (here, the passage 13) within the clean room 1. The multiple support booths 3 are installed adjacent to the multiple work booths 2 in a one-to-one relationship.

[0039] (1.2.3) Passages The passage 13 is an area through which workers pass, connecting the entrance to the clean room 1 and the entrance to the support booth 3 (second opening 5), and is a part of the space within the clean room 1. The passage 13 faces the second opening 5. As shown in FIG. 2, the passage 13 is set in a cleanliness controlled area (grade B).

[0040] (1.2.4) Barrier section The barrier section is provided along the entrance / exit (first opening 4) of each work booth 2, and has the function of blocking airflow from the outside of the work booth 2 through the entrance / exit (first opening 4) toward the inside. As described above, the barrier section according to this embodiment is the support booth 3. The support booth 3 is provided between the work booth 2 and the passage 13. In the support booth 3, an airflow is formed from inside the work booth 2 through the entrance / exit (first opening 4) of the work booth 2 toward the passage 13, and this can block airflow from outside the work booth 2 through the entrance / exit (first opening 4) toward the inside. As a result, microorganisms and the like are prevented from entering the work booth 2 on the airflow. In this embodiment, the function of blocking microorganisms and the like from entering the work booth 2 is referred to as the "barrier function." In the present invention, the barrier function of the barrier section is realized, for example, by maintaining a positive pressure state with respect to the passage 13, but can also be realized by generating an air flow from the support booth 3 toward the passage 13. In addition, the barrier section may be configured by a door that closes the entrance / exit of the work booth 2, or may be configured by an air curtain that flows along the entrance / exit of the work booth 2.

[0041] 2, the support booth 3 is a cleanliness controlled area, with the same cleanliness as the space (here, the passage 13) within the clean room 1. However, in this embodiment, the support booth 3 is monitored more frequently than the passage 13, and is set to grade B+.

[0042] 3, the support booth 3 is configured by partitioning the work booth 2 and the support booth 3 with a front wall 21, an opposing wall 31 arranged at a distance in the forward direction from the front wall 21, a pair of side walls 32, and a top wall 33. In this embodiment, the top wall 33 and the top wall 24 are integral, but may be separate bodies. Also, the adjacent side walls 22 and 32 are separate bodies, but may be integral.

[0043] As shown in Figure 1, the facility 8 has a first opening 4 (i.e., an entrance / exit of the work booth 2) that connects the support booth 3 to the work booth 2 corresponding to the support booth 3, and a second opening 5 (i.e., an entrance / exit of the support booth 3 facing the aisle 13) that connects the support booth 3 to the aisle 13.

[0044] The first opening 4 is formed by penetrating the front wall 21. The first opening 4 is formed to a size that allows a person to pass through. In this embodiment, the first opening 4 does not have a door and is always open, but in the present invention, the first opening 4 may be closed by a door so that it can be opened and closed. The first opening 4 may be formed in the center of the front wall 21 in the width direction, may be formed at an end of the front wall 21 in the width direction, or may be formed between the end and the center of the front wall 21 in the width direction.

[0045] The second opening 5 is formed by penetrating the opposing wall 31. The second opening 5 is formed to a size that allows a person to pass through. The second opening 5 does not have a door and is always open. However, like the first opening 4, the second opening 5 may also be closed by a door so that it can be opened and closed. The second opening 5 is formed at a position that overlaps with the first opening 4 when viewed in a direction perpendicular to the opening surface. Here, "overlapping" means that at least a part of the first opening 4 and the second opening 5 may overlap entirely or partially.

[0046] In the present invention, the position of the second opening 5 does not have to overlap with the first opening 4, and the second opening 5 may be formed in the center of the width direction of the opposing wall 31, or may be formed at an end portion of the opposing wall 31 in the width direction, or may be formed between the end portion and the center of the opposing wall 31 in the width direction, or may be formed in the side walls 22, 32.

[0047] The second opening 5 communicates with the first opening 4. The opening area of ​​the second opening 5 is smaller than the opening area of ​​the first opening 4. Therefore, as a result of the positive pressure generator 6 creating a positive pressure in the work booth 2, the air that has flowed into the support booth 3 through the first opening 4 generates an airflow that flows into the space within the clean room 1 through the second opening 5.

[0048] In this way, by providing a work booth 2 that is maintained at a positive pressure relative to the aisle 13, the support booth 3 acts as a barrier, further preventing microorganisms and the like from entering the work booth 2 from the aisle 13, and also suppressing the effect on the cleanliness within the work booth 2 of changes in air pressure (disturbances) that occur when a worker passes through the aisle 13.

[0049] (1.2.5) Positive pressure generation section The positive pressure generating unit 6 maintains a positive pressure in the work booth 2. This generates an airflow that exits from the work booth 2 through the first opening 4, and generates an airflow that flows from within the support booth 3 toward the passage 13 via the second opening 5.

[0050] In this embodiment, as shown in Fig. 3, the positive pressure generating unit 6 introduces air from within the clean room 1 into the work booth 2 by using multiple (here, two) air inflow devices 61, creating a positive pressure inside the work booth 2. The air inflow devices 61 are attached to the ceiling wall 24 facing the work booth 2. When the work booth 2 becomes positive pressure, the air from within the work booth 2 flows into the support booth 3 through the first opening 4, creating a positive pressure inside the support booth 3. Therefore, the positive pressure generating unit 6 generates an airflow that flows from within the support booth 3 through the second opening 5 and out into the passage 13.

[0051] The air inflow device 61 is attached to an installation hole (not shown) penetrating the top wall 24. The air inflow device 61 includes a fan 62 that takes in air from the clean room 1 into the work booth 2 through an air inlet, and a filter 63. The filter 63 is provided in a flow path through which the airflow formed by the fan 62 flows, and prevents the passage of foreign matter such as microorganisms, lint, and dust floating in the space. Examples of the filter 63 include a medium-performance filter, an electrostatic filter, a HEPA filter (High Efficiency Particulate Air Filter), and a ULPA filter (Ultra Low Penetration Air Filter). From the viewpoint of performance and cost, it is preferable to use a HEPA filter. In addition, the positive pressure generating unit 6 includes two air inflow devices 61 in this embodiment, but in the present invention, it may be one air inflow device 61 or three or more air inflow devices 61.

[0052] As a result of the positive pressure generator 6 maintaining the work booth 2 at a positive pressure, an airflow is generated from the work booth 2, passing through the first opening 4, the support booth 3, and the second opening 5, toward the space within the clean room 1. This forms a barrier section along the entrance and exit of the work booth 2, which not only effectively prevents microorganisms and the like from entering the work booth 2, but also further suppresses the influence of external disturbances caused when a worker passes through the passage 13 from being transmitted to the work booth 2. As a result, contamination within the work booth 2 can be prevented.

[0053] As shown in Fig. 1, the air intakes are provided at multiple locations facing the passage 13. The air intakes and the air inflow device 61 communicate with each other via an air flow passage (e.g., a duct). The multiple air intakes are arranged at intervals along the passage 13. Air in the passage 13 is sucked into the air intakes to create a flow in the passage 13, so that a flow along the passage 13 is generated within the passage 13. The air taken in from the multiple intakes is supplied to the work booth 2 via the duct and the filter 63, and exits from the second opening 5 into the passage 13.

[0054] In this way, the air flowing through the passage 13 repeatedly circulates while passing through the filter 63. Here, the clean room 1 is provided with a plurality of differential pressure dampers to adjust the pressure in the passage 13. Therefore, in the conventional clean room 1, if the air flowing through the passage 13 is contaminated, microorganisms causing the contamination may leak out of the clean room 1 through the differential pressure damper. However, in the equipment 8 according to the present embodiment, the air flowing through the passage 13 is taken in from an air intake facing the passage 13 and repeatedly circulates while passing through the filter 63. Therefore, even if the passage 13 or one of the work booths 2 is contaminated, the microorganisms causing the contamination can be significantly prevented from leaking out of the differential pressure damper. As a result, cross-contamination to another adjacent clean room and / or the spread of contamination to the environment can be prevented.

[0055] (1.3) Method of carrying out the manufacture of the article The equipment 8 configured as above is used to manufacture an article. As shown in Fig. 4, the article is manufactured through a first step S1 of preparing a master cell bank (MCB) and / or a working cell bank (WCB), a second step S2 of expanding and culturing undifferentiated iPS cells, a third step S3 of inducing differentiation, a fourth step S4 of removing undifferentiated iPS cells, a fifth step S5 of storing them by freezing, and a sixth step S6 of preparing a patch, leading to a completed product S7.

[0056] Here, in Fig. 5, the work booths 2 assigned to each process during the manufacture of goods are shown in black. The "work booth" numbers in Fig. 5 correspond to the numbers given to the work booths 2 in Fig. 1. As can be seen from Fig. 5, during the period in which goods are manufactured, there are some work booths 2 that are not being used in the manufacture of goods.

[0057] Therefore, in the method of manufacturing according to the present embodiment, a process simulation test (denoted as "PST" in FIG. 5) is performed using a work booth 2 that is not used for manufacturing an article. For example, during a period of about 4 to 7 weeks in which the first process S1 and the second process S2 are performed in the work booth 2 numbered 1-1, the process simulation test is performed simultaneously in the work booth 2 numbered 1-2, 2-1, 2-2, 3-1, 3-2, 3-3, and 3-4. In addition, during a period of about 4 weeks in which the third process S3 and the fourth process S4 are performed in the work booth 2 numbered 1-1, 1-2, 2-1, 2-2, 3-1, 3-2, and 3-3, the process simulation test is performed simultaneously in the work booth 2 numbered 3-4.

[0058] In other words, in the method for manufacturing an article according to this embodiment, the article is manufactured in at least one work booth 2 out of the multiple work booths 2, and a process simulation test is performed in a work booth 2 other than the work booth 2 out of the multiple work booths 2 in which the article is manufactured.

[0059] This allows the process simulation test to be performed using unused work booths 2, thereby making it possible to reduce the number of unused work booths 2 as much as possible and use the space efficiently. Therefore, in the manufacturing implementation method according to this embodiment, a large facility 8 is not required when both the manufacture of an article and the process simulation test are performed.

[0060] In the sixth process S6, the important intermediates are thawed and patches are produced in response to orders from hospitals and the like (about 3 days); however, periods when there are no orders are downtime periods during which no products are manufactured in work booth 2. Because the sixth process S6 is a process carried out in response to orders, the period during which the sixth process S6 is carried out can be treated as a period during which no work booth 2 is present for the manufacture of products, and a process simulation test can be carried out in one of the work booths 2. The "important intermediates" referred to here refer to frozen and preserved cardiomyocytes produced from iPS cells over a period of about two and a half months.

[0061] (2) Variations The above embodiment is merely one of various embodiments of the present invention. The embodiment can be modified in various ways depending on the design, etc., as long as the object of the present invention can be achieved. Modifications of the embodiment are listed below. The modifications described below can be applied in appropriate combination.

[0062] In the above embodiment, for ease of explanation, other parts of the work booth 2 within the clean room 1 are referred to as the "aisle 13," but the clean room 1 as a "work room" includes the space corresponding to the aisle 13 within the clean room 1, and can also be used as a space for culturing.

[0063] The clean room 1 according to this embodiment is a so-called biological clean room, but in the present invention, it may be an industrial clean room.

[0064] In the above embodiment, the first opening 4 and the second opening 5 are always open, but in the present invention, the first opening 4 and the second opening 5 may be closed by a door so as to be able to be opened and closed.

[0065] In the above embodiment, "Grade B+" and "Grade B" are defined the same using the maximum allowable number of particles and the number of environmental microorganisms, but are distinguished by different monitoring frequencies, but "Grade B+" and "Grade B" may be distinguished using the maximum allowable number of particles or the number of environmental microorganisms. On the other hand, "Grade B+" and "Grade B" may be treated as the same cleanliness level (Grade B) without any distinction.

[0066] (3) Summary As described above, the facility according to the first aspect includes a clean room 1, a plurality of work booths 2 provided in the clean room 1 and having entrances and exits, and a barrier section provided along the entrances of each of the plurality of work booths 2 and obstructing airflow passing through the entrances from outside to inside. The area inside each of the plurality of work booths 2 and the area outside the plurality of work booths 2 and inside the clean room 1 have the same grade of cleanliness.

[0067] According to this embodiment, while an article is manufactured in at least one of the multiple work booths 2, other work can be performed in parallel in the same period in any of the other work booths 2 that are not used for the manufacture of the article. Moreover, even if contamination occurs in the other work booths 2, contamination in the work booth 2 in which the article is being manufactured can be prevented. Moreover, since the area in the work booth 2 and the area outside the work booth 2 and inside the clean room 1 have the same grade of cleanliness, workers do not need to change into clothes according to the cleanliness level when entering and leaving the work booth 2 or moving between the work booths 2, and can work efficiently.

[0068] Furthermore, by providing the barrier section, even if contamination occurs in the clean room 1 due to maintenance being performed on another work booth 2 or a problem occurring in the air conditioning device that conditions the air in the clean room 1, the barrier function of the barrier section can maintain the cleanliness of the work booth 2 in which the article is manufactured. Furthermore, if training of workers who manufacture articles is performed in a work booth 2 other than the work booth 2 in which the article is manufactured, this can pose a risk of contamination occurring in the clean room 1, but the barrier section can maintain the cleanliness of the work booth 2 in which the article is manufactured.

[0069] In the facility 8 according to the second embodiment, the area inside each of the plurality of work booths 2 and the area outside the plurality of work booths 2 and inside the clean room 1 are cleanliness controlled areas.

[0070] According to this embodiment, the space in the work booth 2 where the articles are manufactured can be efficiently kept at a high level of cleanliness. That is, an area requiring a higher level of cleanliness is locally partitioned by the work booth 2, and therefore, for example, by supplying purified air to the clean room 1 through the work booth 2, a high level of cleanliness can be efficiently maintained in the required area compared to the case where the entire clean room 1 is kept at a high level of cleanliness.

[0071] In the facility 8 according to the third embodiment, in the first or second embodiment, at least some of the work booths 2 among the plurality of work booths 2 have an area for aseptic operation, etc., inside.

[0072] According to this aspect, the space in which the article is manufactured can be made to be a space that maintains sterility.

[0073] The equipment 8 according to the fourth aspect is any one of the first to third aspects, in which the barrier section is configured to hinder airflow passing through the entrance / exit of the work booth 2 from the outside to the inside without blocking the entrance / exit.

[0074] According to this embodiment, workers can easily enter and exit the work booth 2 and move between the work booths 2, enabling them to work efficiently.

[0075] The equipment 8 of the fifth aspect is any of the first to fourth aspects, and each of the multiple work booths 2 has a pair of side walls 22, a rear wall 23 provided at the rear ends of the pair of side walls 22, a front wall 21 provided at the front ends of the pair of side walls 22 and having an entrance / exit formed therein, and a ceiling wall 24 provided at the upper ends of the pair of side walls 22, the rear wall 23 and the front wall 21.

[0076] According to this embodiment, since the work booth 2 surrounds an area with high cleanliness, it is easy to maintain a space for manufacturing articles at a locally high cleanliness level.

[0077] In the facility according to the sixth embodiment, in the fifth embodiment, each of the plurality of work booths 2 has a positive pressure generating unit 6 that keeps the inside of the work booth 2 at a positive pressure. The positive pressure generating unit 6 is at least one air inflow device 61 that is provided on the top wall 24 and introduces air in the clean room 1 into the inside of the work booth 2.

[0078] According to this embodiment, even if contamination occurs in the clean room 1, the substances causing the contamination can be prevented from flowing into the work booth 2.

[0079] In the facility 8 according to the seventh embodiment, in the sixth embodiment, the air inflow device 61 has a filter 63 through which the air to be introduced into the work booth 2 passes.

[0080] According to this embodiment, the cleanliness inside the clean room 1 can be constantly kept high, so that even if contamination occurs in one of the work booths 2, the contamination can be prevented from spreading inside the clean room 1.

[0081] The facility 8 according to the eighth embodiment is the same as the seventh embodiment, and further includes a passage 13 connecting a plurality of work booths 2. The air inflow device 61 introduces air taken in from an air intake port facing the passage 13 into the inside of the work booth 2 through a filter 63.

[0082] According to this embodiment, even if contamination occurs in the work booth 2 and / or the passageway 13, the air containing the contamination can be passed through the filter 63 and introduced into the work booth 2, thereby preventing the contamination from leaking outside the clean room 1.

[0083] A method for manufacturing an article according to a ninth aspect is carried out by utilizing the equipment according to any one of the first to eighth aspects. In the method for manufacturing an article, the article is manufactured in at least one work booth 2 out of a plurality of work booths 2, and a work other than the manufacture of the article is carried out in another work booth 2 out of the plurality of work booths 2 other than the work booth 2 in which the article is manufactured.

[0084] According to this embodiment, since other work such as a process simulation test can be performed using the unused work booths 2, the unused work booths 2 can be reduced as much as possible, and the space can be used efficiently. As a result, a large facility 8 is not required when performing both the manufacture of articles and the process simulation test.

[0085] A tenth aspect of the method for manufacturing an article is the ninth aspect, wherein the other work is a process simulation test for verifying the sterility qualification of the manufacture of the article, maintenance of equipment installed in another work booth, or training of persons involved in the manufacture of the article.

[0086] The method for producing an article according to the eleventh aspect is the same as the ninth or tenth aspect, in which the article includes a regenerative medicine product.

[0087] According to this embodiment, when manufacturing regenerative medicine products, both the manufacturing of the products and the process simulation tests can be carried out in one clean room 1, and large facilities 8 are not required.

[0088] The configurations according to the second to seventh aspects are not essential configurations for the facility of the present invention, and may be omitted as appropriate. [Explanation of symbols]

[0089] 1. Clean Room 13 Passage 2 Work booth 21 Front wall 22 Side wall 23 Back wall 24 Ceiling Wall 6 Positive pressure generation section 61 Air inlet device 63 Filters 8 Equipment

Claims

1. Clean rooms and A plurality of work booths are provided in the clean room, each of the work booths has a first opening, and each of the work booths has a positive pressure generating unit that maintains an interior of the work booth at a positive pressure; a plurality of support booths provided adjacent to the plurality of work booths in a one-to-one relationship and having a second opening communicating with the first opening, the support booths having a barrier function of preventing an air flow from the outside of the work booth to the inside thereof by allowing air flowing from the outside of the work booth into the support booth through the first opening to flow outside through the second opening without blocking the first opening and the second opening; an aisle provided in the clean room and facing the second openings of the plurality of support booths; Equipped with The interior areas of the plurality of work booths, the support booths, and the aisles are of the same grade of cleanliness; Equipment.

2. The internal areas of the plurality of work booths, the support booth, and the passageway are cleanliness controlled areas. The facility according to claim 1.

3. At least some of the work booths include an area for aseptic operation, etc. The facility according to claim 1 or 2.

4. (delete)

5. Each of the plurality of work booths comprises: A pair of side walls; a rear wall provided at rear ends of the pair of side walls; a front wall provided at a front end of the pair of side walls and having the entrance formed therein; a top wall provided at upper ends of the pair of side walls, the rear wall, and the front wall; having The facility according to any one of claims 1 to 4.

6. Each of the plurality of work booths has a positive pressure generating unit that maintains a positive pressure inside the work booth, The positive pressure generating unit is at least one air inflow device provided on the ceiling wall and introducing air from the clean room into the work booth. The facility according to claim 5.

7. The air inlet device has a filter through which air is introduced into the work booth. The facility according to claim 6.

8. The air inflow device introduces air taken in from an air intake port facing the passage into the inside of the work booth through the filter. The facility according to claim 7.

9. A method for manufacturing an article using the equipment according to any one of claims 1 to 8, comprising: manufacturing the article in at least one of the plurality of work booths; and performing a work other than the manufacture of the article in a work booth other than the work booth in which the article is manufactured among the plurality of work booths. The method of carrying out the manufacture of the article.

10. The other work is a process simulation test for confirming the qualification of sterility of the production of the article, maintenance of equipment installed in the other work booth, or education and training of persons involved in the production of the article.

10. A method for carrying out the manufacture of the article of claim 9.

11. The article includes a regenerative medicine product, 11. A method for carrying out the manufacture of an article according to claim 9 or claim 10.

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