Clean room system and vehicle equipped with clean room system

Abstract

To realize a clean room system which enables reduction of installation costs or maintenance costs.SOLUTION: A clean room system 10 includes: a clean room 20 having airtightness; an air supply unit 30 which supplies air from the outside 90 of the clean room to the inside 22; and a safety cabinet 40. The safety cabinet 40 includes: a working space 42; a working space air supply passage which supplies air from the inside 22 to the working space 42; a working space exhaust passage which exhausts air from the working space 42 to the outside 90; an exhaust fan 60 which is provided at the working space exhaust passage and drives exhaust air; and a filter 62 which is provided at the working space exhaust passage and cleans the exhaust air. The exhaust fan 60 drives entire exhaust air from the inside 22 to the outside 90 and keeps negative pressure at the inside 22.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present invention relates to a clean room system and a vehicle equipped with a clean room system. [Background technology]

[0002] In a negative pressure clean room, where the internal pressure is kept lower than the external pressure, air flows from the outside to the inside of the clean room through a communication part with the outside. Therefore, in a negative pressure clean room, it is possible to reduce or prevent air containing suspended particles such as infectious substances present inside the clean room from leaking out of the clean room.

[0003] Clean rooms are sometimes equipped with devices such as safety cabinets that provide a work space for performing operations on infectious substances and other work objects. In many cases, the safety cabinet alone controls the intake and exhaust air in the work space.

[0004] Non-Patent Document 1 is the Japanese Industrial Standard JIS for safety cabinets and similar devices. The devices are called biohazard cabinets and are classified into Class I, Class II, and Class III based on their basic structure. Class I and Class II are open types with an opening (front opening) in the front wall of the work space, while Class III is a closed type with no opening.

[0005] Class I equipment is generally called a draft chamber, and air taken in from the front opening is supplied to the work space without being purified, and exhaust air from the work space is purified by a filter and exhausted. Class II equipment is generally called a safety cabinet. Among them, the type with a circulation path takes in air taken in from the front opening into the circulation path. The circulating air is purified by a filter and supplied to the work space, and the process of exhausting from the work space is repeated. In this process, some air is exhausted to the outside after being purified by a filter. In the type without a circulation path, air taken in separately from the outside is purified by a filter and supplied to the work space, and the air supplied to the work space and the air supplied from the front opening are combined, purified by a filter, and exhausted to the outside. Class III is an equipment class generally called an isolator, and air taken in from the outside is purified by a filter and supplied to the work space, and exhaust air from the work space is purified by a filter and exhausted to the outside. Although this standard has the word "bio" in its name, it is not limited to applications in the bio field, but has been formulated with consideration for applications involving the handling of other substances, such as volatile substances.

[0006] The following Patent Document 1 describes a negative pressure type clean room formed by combining partitions. This clean room is used for biological applications, and a safety cabinet is installed inside. In this clean room, the clean room itself and the supply and exhaust system of the safety cabinet are integrated. Specifically, air is supplied to the clean room by an air supply fan, and air is exhausted from the clean room to the outside by an exhaust fan. In addition, a local exhaust fan is also provided separately to exhaust air from the safety cabinet to the outside of the clean room. These fans are controlled by a control unit to maintain a negative pressure inside the clean room.

[0007] The following Patent Document 2 is a document related to a slightly positive pressure open clean room (called a clean booth in this document) using an airflow barrier system equipped with a safety cabinet and the like. A doorless entrance that is always open is provided in the wall of the clean room, and an air supply fan is provided in the ceiling. Air is supplied to the inside of the clean room by the air supply fan. In the safety cabinet, a fan provided in the safety cabinet supplies air inside the clean room, flows it into the work space, and then exhausts the air from the safety cabinet to the inside of the clean room. Then, the air inside the clean room flows in one direction toward the entrance and is exhausted to the outside of the clean room.

[0008] The following Patent Document 3 describes a technology in which cells collected from a patient are processed and then transplanted back into the patient. Cells collected at an academia are processed at a cell culture processing facility (referred to as CPF in the document) and returned to the academia for transplantation into patients at the academia. The cells to be transplanted are treated as pharmaceuticals, and manufacturers are required to carry out a series of process management at CGMP grade in accordance with US laws and regulations (paragraphs 0012 to 0018, etc.). Therefore, this document proposes setting up a facility that meets CGMP grade near the place where the patient receives treatment and carrying out the necessary management, etc. (paragraphs 0019, 0089 to 0118, etc.).

[0009] When performing regenerative medicine, it is necessary to comply with the laws and regulations of the country or region where the treatment is performed. In Japan, the law in Non-Patent Document 2 defines "regenerative medicine products" as follows: "The following items (excluding quasi-drugs and cosmetics) are specified by government ordinance: 1. Items intended for use in the following medical or veterinary medicine, which are cultured or otherwise processed from human or animal cells; a. Reconstruction, repair, or formation of the structure or function of the human or animal body; b. Treatment or prevention of disease in humans or animals; 2. Items intended for use in the treatment of disease in humans or animals, which contain genes that are introduced into human or animal cells and expressed in the body." In addition, the law in Non-Patent Document 3 provides for ensuring the safety of regenerative medicine, including regenerative medicine products. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] JP 2005-326093 A [Patent Document 2] JP 2019-100594 A [Patent Document 3] U.S. Patent Publication No. 2003-0175242A1 [Non-patent literature]

[0011] [Non-Patent Document 1] JIS K3800 Class II Cabinets for Biohazard Prevention Revised on July 20, 2021 [Non-Patent Document 2] Japan's "Act on Ensuring Quality, Effectiveness and Safety of Pharmaceuticals, Medical Devices, etc." [Non-Patent Document 3] Japan's "Act on Ensuring the Safety of Regenerative Medicine, etc." Summary of the Invention [Problem to be solved by the invention]

[0012] There is a need to easily configure a negative pressure type clean room. However, the clean room of the above Patent Document 1 is provided with an exhaust fan that exhausts air from inside the clean room to the outside, and a local exhaust fan that exhausts air from inside the safety cabinet to the outside of the clean room, and the main exhaust system of the clean room and the local exhaust system via the safety cabinet are controlled as an integrated unit, so that the exhaust structure is redundant. The above Patent Document 2 describes a simple exhaust structure, but it is merely a structure that is only possible for a positive pressure type clean room.

[0013] An object of the present invention is to realize a negative pressure clean room system that reduces manufacturing costs or maintenance costs.

[0014] In addition, in order to facilitate the regenerative medicine, there is a need to provide a clean room for handling cells in or near the hospital where the patient receives treatment. However, the above-mentioned Patent Document 3 does not take into consideration the costs of setting up or maintaining the facility.

[0015] Another object of the present invention is to facilitate the installation and maintenance of clean rooms in hospitals and the like that perform regenerative medicine or in their vicinity. [Means for solving the problem]

[0016] The clean room system according to the present invention includes an airtight clean room, a room air supply path for supplying air from the outside of the clean room to the inside, a work space, a work space air supply path for supplying air from the inside of the clean room to the work space, and a circulation path for taking in air from the work space and supplying it again to the work space. A flow path having a common portion with the circulation path, which branches off from the circulation path midway and leads to the outside. a work space exhaust path for exhausting air from the work space to the outside of the clean room; The exhaust passage is provided in the common portion of the circulation passage and the working space exhaust passage or at a portion where the circulation passage and the working space exhaust passage are separated from each other. Circulation in the circulation path and Workspace an exhaust fan that drives exhaust in an exhaust path, and a filter that is provided in the work space exhaust path and purifies the exhaust, and a hazard control cabinet that is installed inside the clean room; No other fan is provided in the circulation path between the location where the exhaust fan is provided and the working space, Circulation in the circulation path and Workspace The exhaust fan driving the exhaust in the exhaust path drives total exhaust from the inside of the clean room to the outside and maintains the inside of the clean room at a negative pressure.

[0017] A work space is a space where a worker or equipment works on a work object. A hazard control cabinet is a device that has a work space with controlled intake and exhaust, and is used to control hazards caused by fine particles generated in the work space. Hazard control refers to measures to reduce or eliminate danger to workers or the surrounding environment. Hazard control cabinets include, but are not limited to, biohazard control cabinets with the basic structures of classes I, II, and III described in Non-Patent Document 1 above. Hazard control cabinets include those that do not meet the conditions of values, configuration, materials, etc. specified in Non-Patent Document 1 above, but can implement hazard control at the level required by the user as a whole.

[0018] The maintenance of a negative pressure inside the clean room means that the air pressure inside the clean room is controlled to be lower than the air pressure outside the clean room in terms of time average value, or that the air flow is directed from the outside of the clean room to the inside in terms of time average value. Since the air pressure varies both temporally and spatially due to the operation of the fan and turbulence of the flow, the time average can be taken to evaluate the state in which this variation has been smoothed. The period for taking the time average depends on the response speed of the air pressure sensor, but it can be, for example, about 60 seconds, 30 seconds, or 10 seconds. The direction of the air flow can be confirmed by a smoke test. The air pressure difference between the inside and outside can be set in various ways, and specific values ​​include 30 Pa, 20 Pa, 10 Pa, 5 Pa, 3 Pa, and 1 Pa. The air pressure difference can be set according to the level at which it is desired to reduce or prevent the leakage of air particles from the inside of the clean room to the outside. The air pressure difference can also be set taking into consideration the ease of opening and closing the entrance door, the suppression of wind noise, the power consumption of the fan, or the ventilation of the filter. If the air pressure difference is small, there may be a situation in which the air pressure inside the clean room becomes higher than the air pressure outside (positive pressure) for a certain short period of time. However, if the amount of air leaking to the outside as a result of the positive pressure is small and the clean room system can maintain a level that allows hazard countermeasures, this short period of positive pressure can be tolerated.

[0019] In this clean room system, the hazard control cabinet includes a workspace air supply path, a workspace exhaust path, an exhaust fan, and a filter, and these components are inseparable parts closely related to the air supply and exhaust in the clean room itself. In this respect, it can be said that the clean room and the hazard control cabinet are integrally configured. Therefore, some or all of these components may not be components belonging to the hazard control cabinet, but may be handled in product catalogs as components provided in the clean room or as separately provided components. Even in such cases, if these components are necessary elements to realize a biohazard control cabinet, they are components of the hazard control cabinet and satisfy the constituent requirements of the present invention.

[0020] In one aspect of the present invention, a bypass passage is provided that communicates with the work space exhaust path from inside the clean room without passing through the work space, and the exhaust fan also drives the air that flows through the bypass passage. In another aspect, a bypass passage is not provided, and only the air that has passed through the work space is exhausted.

[0021] In one aspect of the present invention, the hazard control cabinet is a safety cabinet, and the work space is a space where work is performed on biological objects. The safety cabinet includes, but is not limited to, a cabinet that satisfies the biohazard control cabinet class II in the above-mentioned Non-Patent Document 1. Even if the cabinet does not satisfy the conditions of the numerical values, configuration, materials, etc., specified in the above-mentioned Non-Patent Document 1, it is acceptable as long as it can implement biohazard control at the level required by the user as a whole.

[0022] In one aspect of the present invention, the room air supply passage is a natural air supply passage that supplies air using the negative pressure inside the clean room created by the exhaust fan as a driving force.

[0023] In one aspect of the present invention, the work space is a space where work is performed on regenerative medical products manufactured in a cell culture processing facility, and the clean room system is installed near the treatment location where the regenerative medical products are used.

[0024] Regenerative medicine products include, but are not limited to, regenerative medicine products defined in Non-Patent Document 2 above. Regenerative medicine products also include general cell processed products in which animal cells are cultured or otherwise processed. Regenerative medicine products also include products that are classified as drugs, quasi-drugs, cosmetics, veterinary medicines, etc. by laws and regulations. Similarly, the treatment site refers to the place where treatment is given to patients, and also includes the place where treatment is given to humans or animals that are not treated as medical care by laws and regulations.

[0025] Regenerative medical products include those provided for a fee as well as those provided free of charge.

[0026] In one aspect of the present invention, the treatment locations are distributed across two or more buildings, and the clean room system is installed in a location adjacent to the treatment locations in at least two or more buildings.

[0027] The vehicle equipped with a clean room system according to the present invention comprises the clean room system and a vehicle equipped with the clean room, the work space being a space where work is carried out on regenerative medical products manufactured in a cell culture processing facility, and the vehicle is capable of moving to the vicinity of a treatment location where the regenerative medical products are used. Effect of the Invention

[0028] A clean room system capable of reducing manufacturing costs or maintenance costs is realized. [Brief description of the drawings]

[0029] [Figure 1] FIG. 1 is a perspective view of a clean room system according to a first embodiment. [Diagram 2] FIG. 1 is a top view of the clean room system according to the first embodiment. [Diagram 3] FIG. 1 is a side view of a clean room system according to a first embodiment. [Figure 4] FIG. 2 is a diagram showing a control mode of the clean room system according to the first embodiment. [Diagram 5] FIG. 11 is a side view of the clean room system according to the second embodiment. [Figure 6] FIG. 11 is a side view of the clean room system according to the third embodiment. [Figure 7] FIG. 11 is a side view of the clean room system according to the fourth embodiment. [Figure 8] FIG. 13 is a side view of the clean room system according to the fifth embodiment. [Figure 9] FIG. 13 is a diagram illustrating an example of use of the clean room system according to the sixth embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0030] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Each embodiment is an example, and it should be noted that the present invention can be embodied in various forms. Also, each drawing is a schematic diagram simply illustrating the features of the embodiment, and the structure and scale are not necessarily accurate.

[0031] (1) First embodiment Fig. 1, Fig. 2 and Fig. 3 are respectively a perspective view, a top view and a side view of the clean room system 10 according to the first embodiment. Fig. 4 is a block diagram showing the control mode of the clean room system 10 according to the first embodiment.

[0032] First, the overall configuration of a clean room system 10 will be described with reference to Figures 1 to 3. The clean room system 10 is a system formed by a clean room 20 in which the cleanliness is controlled, and associated devices and the like.

[0033] The clean room 20 is a closed structure that includes a floor, walls, and a ceiling, and keeps the space of the interior 22 airtight. "Airtight" refers to a state in which the flow of air between the interior 22 and the exterior 90 is reduced or blocked, and "airtightness" refers to the property of keeping a space airtight. The airtightness of the clean room 20 makes it possible to control the cleanliness of the interior 22 of the clean room 20. The cleanliness is quantified, for example, by the amount of fine particles in the air. The floor, walls, and ceiling of the clean room 20 are formed, for example, by tightly combining panel members produced in a quality-controlled factory. It is also possible to form a part or all of the walls, floor, and ceiling of the clean room 20 by utilizing the structure of an existing building. When the clean room 20 is installed inside a building, the exterior 90 of the clean room 20 may be a general indoor space whose cleanliness is not controlled, or may be another clean room whose cleanliness is controlled. The clean room 20 can also be installed outdoors with its outer surface exposed to the outdoors. 1 to 3, clean room 20 is illustrated assuming that it is approximately 3 m in each of the two horizontal directions and approximately 2 m in height. However, the size can be set in various ways, and it may be smaller (for example, approximately 2 m in one or both of the two horizontal directions) or larger (for example, approximately 4 m, 6 m, or 10 m in one or both of the two horizontal directions, or approximately 3 m or 4 m in height).

[0034] The clean room system 10 according to the first embodiment includes a buffer room 24 adjacent to the clean room 20 in addition to the clean room 20. The buffer room 24 is a room between the inside 22 and the outside 90 of the clean room 20, and serves as a buffer space when workers enter and exit the room or when work objects are inserted and removed. The buffer room 24 includes an outer door 26 and an inner door 28. The outer door 26 is used for entering and exiting between the outside 90 and the buffer room 24, and the inner door 28 is used for entering and exiting between the buffer room 24 and the inside 22 of the clean room 20. The outer door 26 and the inner door 28 are controlled so that they cannot be opened at the same time, and direct ventilation between the inside 22 of the clean room 20 and the outside 90 is prevented. In addition, by providing the buffer room 24, the change in air pressure in the inside 22 of the clean room 20 at the time of entering and exiting can be reduced, and air turbulence can be suppressed.

[0035] In the clean room 20, an air supply unit 30 and a safety cabinet 40 are provided as devices constituting the clean room system 10.

[0036] The air supply unit 30 is a device that controls the air supply to the clean room 20. The air supply unit 30 is installed in a flow path (called a "room air supply path") that supplies air from the outside 90 to the inside 22 of the clean room 20. In the clean room system 10, the room air supply path is provided in a position relatively close to the buffer room 24 in the ceiling of the clean room 20. The air supply unit 30 is a unitized device in which a HEPA filter 32 and an air supply fan 34 are stacked on top of each other, and is detachably attached to the room air supply path. The HEPA filter 32 is a filter that removes fine particles in the air according to the HEPA (High Efficiency Particulate Air) standard. The HEPA filter 32 is detachably attached to the air supply fan 34. For this reason, cleaning and replacement of the HEPA filter 32 can be easily performed by removing the air supply unit 30 and then removing the HEPA filter 32.

[0037] The supply air fan 34 is a device equipped with a fan for supplying air. The term "fan" broadly refers to a device that drives air, and includes various structures such as a propeller fan, a centrifugal fan, and a composite fan that combines these. The supply air fan 34 operates by receiving power from a power line (not shown), and drives air from the outside 90 to the inside 22 of the clean room 20. At this time, the air flows through the HEPA filter 32, so that fine particles contained in the air outside 90 are removed.

[0038] The safety cabinet 40 is an open-type hazard control cabinet having a front opening 44. The safety cabinet 40 is provided near a wall surface far from the buffer room 24 in the interior 22 of the clean room 20. The safety cabinet 40 has a working space 42, a front opening 44, a HEPA filter 46, flow paths 50a to 50f, an exhaust fan 60, and a HEPA filter 62.

[0039] The work space 42 is a space provided for performing work on a work object, and may also be called a work hood, work chamber, or the like. The work space 42 is provided inside the safety cabinet 40 in a substantially rectangular parallelepiped shape. A HEPA filter 46 is provided on the upper surface of the work space 42. The wall at the front of the work space 42 (the side closer to the center of the room in the drawing, where the worker is located) is formed of a transparent glass plate, but the lower part of the wall is a front opening 44 without a resin plate. A hole leading to a flow path 50a, which will be described later, is provided on the bottom surface of the work space 42 or around the periphery thereof.

[0040] The front opening 44 is a part that communicates with the interior 22 of the clean room 20, and is used not only for workers to put their arms and work objects in and out, but also as a flow path for supplying air from the interior 22 of the clean room 20 to the equipment.

[0041] The HEPA filter 46 is installed on the upper surface of the working space 42. The HEPA filter 46 is a filter that purifies the air supplied to the working space 42, and air flows from its upper surface to its lower surface. The air that passes through the HEPA filter 46 is purified to a level that allows operations called aseptic operations to be performed in the working space 42.

[0042] As shown in FIG. 3, air flow paths 50a to 50f are provided around the work space 42. The flow path 50a is provided below the work space 42 and communicates with a hole provided on the bottom surface of the work space 42. The flow path 50a extends substantially horizontally in the front-rear direction of the safety cabinet 40. The flow path 50b is provided at the rear of the work space 42 and extends in the up-down direction (vertical direction). The lower end of the flow path 50b communicates with the rear end of the flow path 50a. The flow path 50c is a flow path located on an extension line of the flow path 50b and extends in the up-down direction. The lower end of the flow path 50c communicates with the upper end of the flow path 50b via the exhaust fan 60. The flow path 50d is a flow path located on an extension line of the flow path 50c and extends in the up-down direction. The lower end of the flow path 50 d communicates with the upper end of the flow path 50 c via a HEPA filter 62 , and the upper end of the flow path 50 d communicates with the outside 90 of the clean room 20 .

[0043] The flow path 50e is located above the working space 42 and extends almost horizontally in the front-rear direction of the safety cabinet 40. The rear end of the flow path 50e is connected to the upper end of the flow path 50b via the exhaust fan 60, and the front end of the flow path 50e is connected to the upper surface of the HEPA filter 46. The flow path 50f is an air flow path in the working space 42, and flows almost uniformly downward in the working space 42. The upper end of the flow path 50f is connected to the lower surface of the HEPA filter 46 and is connected to the front end of the flow path 50e via the HEPA filter 46. The lower end of the flow path 50f is connected to the flow path 50a via a hole provided on the bottom surface of the working space 42. In addition, the front lower part of the flow path 50f is connected to the inside 22 of the clean room 20 (and the outside of the safety cabinet 40) via the front opening 44. A part or all of the flow paths 50a to 50e can be formed, for example, using a tubular duct, or can be formed using a plate-shaped member. In this embodiment, the flow paths 50a to 50e are attached to a frame constituting the safety cabinet 40, and are further covered with a cover of the safety cabinet 40, so that they are formed integrally with the safety cabinet 40.

[0044] The exhaust fan 60 is connected to the flow paths 50b, 50c, and 50 e The exhaust pipe is provided at the portion where the exhaust pipe is connected. The exhaust fan 60 includes a fan that drives air and is powered by electricity. The pump 60 sucks air from the flow path 50b and connects the flow path 50c and the flow path 50b. e Distribute and discharge. The distribution ratio may be fixed or variably controlled, for example by using an electrically operated movable valve. This may be done.

[0045] The HEPA filter 62 is detachably provided between the flow paths 50c and 50d. The HEPA filter 62 is a filter that purifies the exhaust air discharged from the inside 22 of the clean room 20 to the outside 90 to a level where hazards can be prevented or reduced.

[0046] Typically, one HEPA filter 62 is provided at one location in the flow paths 50c, 50d, but it is also possible to provide them at multiple locations, and it is also possible to provide multiple filters at one location.

[0047] Next, the operation of the clean room system 10 will be described. In the clean room system 10, an operator enters the interior 22 of the clean room 20 from the outside 90 via the buffer room 24. At this time, the operator first opens the outer door 26 to enter the buffer room 24 and closes the outer door 26. If the buffer room 24 is used as a dressing room, the operator puts on prescribed clothes, etc. Next, the operator opens the inner door 28 to enter the interior 22 of the clean room 20 and closes the inner door 28. The outer door 26 and the inner door 28 are controlled by an interlock, and are set so that both cannot be opened at the same time.

[0048] In the interior 22 of the clean room 20, a worker is positioned in front of the safety cabinet 40, either standing or sitting on a chair. The worker then manipulates the work object while putting the work object or his / her arm in and out of the work space 42 through the front opening 44.

[0049] In the clean room 20, air 70a is supplied from the outside 90 to the inside 22 through an air supply unit 30 provided in the room air supply path. The air supply is driven by an air supply fan 34. The air 70a flows into the inside 22 of the clean room 20 after being purified by a HEPA filter 32.

[0050] In the interior 22 of the clean room 20, air 70b flows from the air supply unit 30 toward the front opening 44 of the safety cabinet 40. The air 70b is controlled to have relatively little turbulence and flows approximately in one direction. Then, air 70c is taken into the interior of the safety cabinet 40 from the front opening 44 and enters the flow path 50a.

[0051] Inside the safety cabinet 40, the air is driven by an exhaust fan 60 (of course, the air supply by the supply fan 34 also indirectly drives the air). The functions of the exhaust fan 60 can be classified into the following three functions. The first is to supply air from the interior 22 of the clean room 20 to the working space 42. The second is to circulate air inside the safety cabinet 40. The third is to exhaust air to the outside 90. Each of these functions will be explained in detail below.

[0052] In the first air supply, air starts from the interior 22, passes through the front opening 44, the front lower part of the work space 42 (which is also the front lower part of the flow path 50f), flow paths 50a, 50b, and 50e, and is supplied to the work space 42. This flow path supplies air from the interior 22 of the clean room 20 to the work space 42, and is referred to as the "work space air supply path." An exhaust fan 60 is provided midway along the work space air supply path, and drives the supply of air to the work space 42. A HEPA filter 46 is also provided in the work space air supply path, and purifies the air supplied to the work space 42.

[0053] In the second circulation, the air flows through a circulation path consisting of a flow path 50e, a flow path 50f (work space 42), a flow path 50a, and a flow path 50b. An exhaust fan 60 is provided in this circulation path to drive the circulating air. A HEPA filter 46 is also provided in the circulation path to purify the air passing through.

[0054] In this circulation path, the amount of air flowing into the flow path 50a from the holes provided in the bottom surface of the working space 42 is greater than the amount of air supplied to the working space 42 through the HEPA filter 46. This is because the exhaust fan 60 continuously exhausts a portion of the circulating air. As a result, the working space 42 becomes air-deficient and negative pressure is generated, so that air is continuously sucked in through the front opening 44 at the front lower part of the working space 42. The continuous suction flow formed at the front opening 44 reduces or prevents fine particles scattered inside the working space 42 from leaking into the interior 22 of the clean room 20.

[0055] The third exhaust can be understood from two viewpoints. One is the viewpoint of exhaust from the working space 42 to the outside 90. From this viewpoint, air flows through an exhaust path (called a "working space exhaust path") that starts from the working space 42 and reaches the outside 90 via the flow paths 50a, 50b, 50c, and 50d. The other is the viewpoint of exhaust from the inside 22 of the clean room 20 to the outside 90. From this viewpoint, air flows through an exhaust path (called a "room exhaust path") that starts from the inside 22, passes through the front opening 44, the front lower part of the working space 42 (the front lower part of the flow path 50f), and reaches the outside 90 via the flow paths 50a, 50b, 50c, and 50d. The flow path (called a "common exhaust path") that is common to the working space exhaust path and the room exhaust path is the flow paths 50a, 50b, 50c, and 50d. An exhaust fan 60 and a HEPA filter 62 are both provided in this common exhaust path, and serve to drive the exhaust and purify the exhaust, respectively.

[0056] The exhaust fan 60 exhausts air by discharging a portion of the air sucked from the flow path 50b to the flow path 50c. The air flowing through the flow path 50b includes air that has flowed through the work space 42 and air that has flowed in from the front opening 44 but has not yet flowed through the work space 42. The latter air starts from the interior 22 of the clean room 20, passes through a "detour" consisting of the front opening 44 and the front lower part of the work space 42, and merges with the work space exhaust path, thereby bypassing the work space 42 and being exhausted directly to the outside 90. The combination of the detour and the common exhaust path constitutes the room exhaust path. The exhaust fan 60 drives the flow of the detour.

[0057] The HEPA filter 62 purifies the air flowing in from the flow path 50c to reduce the number of particles in the air to a standard value or less, and then the air flows into the flow path 50d. This reduces or prevents the leakage of particles (e.g., infectious microorganisms, viruses, etc., which are the target of hazard countermeasures and have been mixed in the working space 42, to the outside 90. The particles include not only the substances themselves, but also aerosolized substances.

[0058] The exhaust air sent to the outside 90 through the exhaust fan 60 is the total exhaust air sent from the inside 22 of the clean room 20 to the outside 90. Here, the total exhaust air refers to the total amount of exhaust air that is controlled during the operation of the clean room system 10 and is exhausted from the clean room 20, and does not include air leaking from minute gaps in the walls of the clean room 20, air turbulently flowing back from the air supply unit 30, and air leaking from the buffer room 24 when workers enter and leave the room. In the clean room system 10, the exhaust fan 60 drives the total exhaust air, so that the exhaust structure is simple and the manufacturing cost or maintenance cost can be reduced. In addition, in the clean room system 10, the number or locations of the HEPA filters 62 installed in the common exhaust path can be reduced, which may reduce the manufacturing cost or maintenance cost.

[0059] In the clean room system 10, the interior 22 of the clean room 20 is maintained at negative pressure. In the negative pressure type clean room 20 in which the interior 22 is maintained at negative pressure, it is possible to reduce or prevent air leakage from the walls of the clean room 20, air leakage from the air supply unit 30, or air leakage from the buffer room 24 when entering or leaving the room. This makes it possible to prevent or reduce the leakage of fine particles generated during work in the work space 42 to the outside 90.

[0060] The exhaust fan 60 is operated with a power sufficient to maintain a negative pressure in the clean room 20. The power required to operate the exhaust fan 60 also depends on the magnitude of the power of the supply air fan 34. Therefore, in the clean room system 10, various conditions are monitored to control the exhaust fan 60 and the supply air fan 34.

[0061] Now, with reference to FIG. 4, an example of control of the exhaust fan 60 and the supply air fan 34 in the clean room system 10 will be described.

[0062] The UI100 is a user interface having an input section and a display section formed by a touch panel display or the like. The UI100 may be installed, for example, near the entrance of the clean room 20, or may be implemented in a terminal that an operator can carry. The display section of the UI100 displays the operating status of the clean room system 10, and the input section accepts various inputs from the user. Examples of the inputs include an instruction input to start or stop the clean room system 10, an input to switch the operating power when the working space 42 is in use or not in use, and an input to set the cleanliness level.

[0063] The outdoor pressure sensor 102 and the indoor pressure sensor 104 are pressure sensors installed respectively outside 90 and inside 22 of the clean room 20. The indoor temperature sensor 106 is a temperature sensor installed inside 22 of the clean room 20. The indoor particle sensor 107 and the workspace particle sensor 108 are sensors installed respectively inside 22 and workspace 42 of the clean room 20, and measure suspended particles in the air in the spaces in which they are installed. These various sensors perform measurements in real time.

[0064] The control device 110 is a device that operates by controlling computer hardware including a central processing unit and a memory by embedded software. The control device 110 has a recording unit 112, a calculation unit 114, and an operation mode table 116 built under the control of the embedded software. The recording unit 112 records the operation status of the clean room system 10. The data to be recorded includes sensing data transmitted from various sensors to the control device 110, and operation data transmitted from the supply air fan 34 and the exhaust fan 60 to the control device 110. The recording unit 112 also records instruction data and setting data transmitted from the UI 100, and control status data in the control device 110. The calculation unit 114 switches the operation modes of the supply air fan 34 and the exhaust fan 60 according to the instruction data transmitted from the UI 100. Then, the calculation unit 114 refers to the operation mode table 116 and instructs the supply air fan 34 and the exhaust fan 60 to operate in the corresponding operation mode. Furthermore, the calculation unit 114 monitors sensing data sent from various sensors to the control device 110 and performs feedback control to finely adjust the power of the intake air fan 34 and the exhaust fan 60.

[0065] The operation mode table 116 is data that sets the power of the intake air fan 34 and the exhaust fan 60 in various operation modes. The operation mode is the operating state of the intake air fan 34 and the exhaust fan 60. The operation modes include a stop mode, a normal operation mode, a high power mode, a low power mode, and the like. In addition, the operation modes may include a power saving mode in which the intake air fan 34 and the exhaust fan 60 are operated at a low power consumption when the safety cabinet 40 is not used. The operation mode table 116 sets the numerical value of the power at which the intake air fan 34 and the exhaust fan 60 should be operated in each operation mode.

[0066] The supply air fan 34 and the exhaust fan 60 operate with their power adjusted under the control of the control device 110. In addition, actual power data of the supply air fan 34 and the exhaust fan 60 is transmitted to the control device 110 and monitored by the calculation unit 114.

[0067] In addition, in the clean room system 10, the clean room 20 can be maintained at a positive pressure (meaning a state in which the pressure in the interior 22 is higher than the pressure in the exterior 90 on average over time) by controlling the power of the air supply fan 34 to be relatively increased. A positive pressure clean room 20 is suitable for applications in which particulate matter flowing from the exterior 90 into the interior 22 is reduced or prevented. When there is a need for operation at positive pressure, the control device 110 may be configured to switch the clean room system 10 between negative pressure and positive pressure based on an input from the UI 100.

[0068] In the above explanation, the supply air fan 34 and the exhaust fan 60 are controlled while monitoring various data. However, if the fan operates to ensure the necessary negative pressure, the supply air fan 34 and the exhaust fan 60 may be configured not to be controlled based on monitoring.

[0069] In addition, in the above description, the air supply and exhaust are performed from the ceiling portion, but one or both of the air supply and exhaust may be performed from a portion other than the ceiling (wall or floor).

[0070] In the above description, the clean room system 10 uses the HEPA filters 32, 46, 62 as filters for purifying the air. HEPA is a high-precision particulate filter whose specific performance is defined by JIS, ISO, EN, and other standards. The clean room system 10 installs the HEPA filters 32, 46, 62 in accordance with the appropriate standards. By using HEPA, it is expected that the required cleanliness will be ensured in many cases where the clean room system 10 is used. However, in the clean room system 10, some or all of the HEPA filters 32, 46, 62 can be replaced with other filters depending on the required cleanliness. For example, instead of HEPA, a higher performance filter (e.g., ULPA) or a lower performance filter can be used. In addition to those that utilize the fineness of the filter, there are also those that utilize static electricity to capture particulates using HEPA. In the type that utilizes static electricity, it is generally necessary to operate continuously to constantly generate static electricity in order to continue adsorbing particulates. In the case of a type that utilizes static electricity, when implementing the above-mentioned power saving mode, for example, the amount of intake and exhaust air may be controlled at a level that can prevent the falling of fine particles or keep them at a predetermined level.

[0071] In the above explanation, the clean room system 10 is provided with the buffer room 24. However, the clean room system 10 may be formed compactly without providing the buffer room 24. In another embodiment, the buffer room 24 may be used exclusively for entrance, and a separate buffer room may be provided exclusively for exit.

[0072] In the above description, the safety cabinet 40, which is an open-type hazard control cabinet, has been taken as an example. However, the above embodiment can be easily applied to open-type hazard control cabinets other than the safety cabinet 40, such as a draft chamber.

[0073] In a draft chamber, air taken in from the front opening (corresponding to the working space air supply path) is supplied directly to the working space. In addition, a working space exhaust path is provided to exhaust the air in the working space to the outside of the clean room, and an exhaust fan and filter are installed in the working space exhaust path. The flow path consisting of the front opening, working space, and working space exhaust path corresponds to the room exhaust path, and the working space exhaust path coincides with the common exhaust path. By not providing any other exhaust path leading to the outside of the clean room, it is possible to form a negative pressure type clean room system in which the exhaust fan drives all the exhaust and the filter purifies all the exhaust.

[0074] (2) Second embodiment A clean room system 210 according to the second embodiment will be described with reference to Fig. 5. Fig. 5 is a side view according to the second embodiment. In Fig. 5, parts that are the same as or almost similar to those in Fig. 3 (side view according to the first embodiment) are given the same reference numerals, and descriptions thereof will be simplified or omitted.

[0075] In the clean room system 210, the clean room 220 includes an air supply unit 30 and a safety cabinet 240. The safety cabinet 240 includes a work space 42, a front opening 44, a HEPA filter 46, flow paths 250a-250f, an exhaust unit 261, and a work space air supply fan 264. The flow paths 250a-250f are formed in approximately the same positions and with the same shapes as the flow paths 50a-50f of the first embodiment, respectively.

[0076] However, the upper end of the flow path 250b communicates with the lower end of the flow path 250c and the rear end of the flow path 250e. An exhaust unit 261 is detachably attached near the connection point of the flow paths 250c and 250d. The exhaust unit 261 is a unit formed by stacking an exhaust fan 260 and a HEPA filter 262 directly above it. The HEPA filter 262 is a filter that purifies exhaust air, and is detachably attached to the exhaust unit 261. Therefore, when cleaning or replacing the HEPA filter 262, it is possible to first remove the exhaust unit 261 and then remove the HEPA filter 262 from the exhaust unit 261. A work space supply fan 264 is provided near the front end of the flow path 250e. The work space supply fan 264 is a fan that drives the supply of air to the work space 42.

[0077] In the second embodiment, the work space air supply path is a path that starts from the interior 22, passes through the front opening 44, the front lower part in the work space 42 (front lower part of the flow path 250f), the flow paths 250a, 250b, and 250e, and reaches the work space 42. The work space exhaust path is a path that starts from the work space 42, passes through the flow paths 250a, 250b, 250c, and 250d, and reaches the outside 90. The room exhaust path is a path that starts from the interior 22, passes through the front opening 44, the front lower part in the work space 42, and the flow paths 250a, 250b, 250c, and 250d, and reaches the outside 90. The common exhaust path is a path that is made up of the flow paths 250a, 250b, 250c, and 250d. The circulation path is made up of the work space 42 (flow path 250f), and the flow paths 250a, 250b, and 250e.

[0078] The exhaust fan 260 drives to exhaust the air in the interior 22 to the outside 90 through the front opening 44, the lower front part in the work space, and the flow paths 250a, 250b, 250c, and 250d. On the other hand, the exhaust fan 260 does not drive the flow path 250e and the work space 42. This can be understood by considering a state in which only the exhaust fan 260 is operated and the work space supply fan 264 is stopped. Also, the work space supply fan 264 is a circulation drive fan that drives only the flow of the circulation path consisting of the work space 42, the flow paths 250a, the flow paths 250b, and the flow paths 250e. This can be understood by considering a state in which the exhaust fan 260 is stopped and only the work space supply fan 264 is operated. Of course, when the exhaust fan 260 and the work space supply fan 264 are operated simultaneously, a nonlinear effect occurs in addition to the linear superposition. However, this nonlinear effect is limited, and if the effect of the work space supply fan 264 on the exhaust air is not taken into consideration, it can be considered that the exhaust fan 260 provided in the common exhaust path drives all the exhaust air. Also, it can be considered that the HEPA filter 262 provided in the common exhaust path purifies all the exhaust air. In the second embodiment, although there is redundancy in that the work space supply fan 264 is provided compared to the first embodiment, the exhaust structure is realized simply.

[0079] In the above description, an example in which only one safety cabinet 240 is installed inside the clean room 220 has been given. However, multiple hazard control cabinets of the same or different types can be installed in the clean room 220. In an embodiment in which multiple hazard control cabinets are installed, it is necessary to provide a work space exhaust path that exhausts air from each work space to the outside 90 of the clean room 220. Each work space exhaust path may be structured so that it does not join together but communicates with the outside 90 separately and is provided with an exhaust fan and a filter. Also, each work space exhaust path may be joined together so that the joint path communicates with the outside 90. In the case of joining together, an exhaust fan and a filter may be provided only in the joint path. In the case of providing an exhaust fan only in the joint path, a circulation drive fan may be provided in each hazard control cabinet to drive the circulation of air in each hazard control cabinet.

[0080] (3) Third embodiment A clean room system 310 according to the third embodiment will be described with reference to Fig. 6. Fig. 6 is a side view according to the third embodiment. In Fig. 6, the same or almost similar parts as those in Fig. 3 (side view according to the first embodiment) are denoted by the same reference numerals, and the description will be simplified or omitted.

[0081] In the clean room system 310, the clean room 320 includes an air supply unit 30 and an isolator 340. The isolator 340 is a closed hazard control cabinet, and includes a work space 342 with no opening. A glove box 344 is provided on the front side of the isolator 340 instead of a front opening. The glove box 344 has a flexible groove protruding toward the work space 342. The glove is airtight, and a worker who puts his or her hands into the glove can operate a work object inside the work space 342 from outside the work space 342.

[0082] Flow paths 350a to 350f are provided around the working space 342. The flow path 350a is a flow path that supplies air to the isolator 340 in the interior 22 of the clean room 320. The flow path 350a is located above the working space 342 and extends almost horizontally in the front-rear direction. The front end of the flow path 350a is open to the interior 22 of the clean room 320. The flow path 350b is a flow path for air that flows almost uniformly downward through the working space 342. The upper end of the flow path 350b communicates with the rear end of the flow path 350a via the HEPA filter 46. The HEPA filter 46 is a filter that purifies the air that flows into the working space 342. The flow path 350c is a flow path provided below the working space 342 and extends almost horizontally in the front-rear direction of the isolator 340. The flow path 350c communicates with the flow path 350b via a hole provided on the bottom surface of the working space 342. The flow path 350d is a flow path provided at the rear of the working space 342, and extends in the vertical direction, with its upper end reaching a position higher than the upper surface of the working space 342. The lower end of the flow path 350d communicates with the rear end of the flow path 350c. The flow path 350e is a flow path provided on an extension of the flow path 350d, and extends in the vertical direction. The lower end of the flow path 350e communicates with the upper end of the flow path 350d via the exhaust fan 360. The flow path 350f is a flow path provided on an extension of the flow path 350e, and extends in the vertical direction. The lower end of the flow path 350f communicates with the upper end of the flow path 350e via the HEPA filter 362. The upper end of the flow path 350f is open to the outside 90 of the clean room 320.

[0083] The exhaust fan 360 is a fan that drives the exhaust. The exhaust fan 360 is provided between the flow path 350d and the flow path 350e. The HEPA filter 362 is a filter that purifies the exhaust. The HEPA filter 362 is provided between the flow path 350e and the flow path 350f.

[0084] In the clean room system 310, air 70a is supplied to the interior 22 of the clean room 320 through the air supply unit 30. In the interior 22, air 370b flows approximately in one direction and reaches the front end of the flow path 350a. The air that has flowed through the flow path 350a is purified by the HEPA filter 46, then flows through the flow path 350b inside the working space 342, and enters the flow path 350c through a hole provided on the bottom surface of the working space 342. The air that has entered the flow path 350c moves to the flow path 350d, is sucked by the exhaust fan 360, and is discharged to the flow path 350e. The air is then purified by the HEPA filter 362, passes through the flow path 350f, and is then discharged to the outside 90.

[0085] Only air purified by the HEPA filter 46 flows into the work space 342 of the isolator 340, so that a high level of cleanliness can be achieved. In addition, the exhaust air from the work space 342 is purified by the HEPA filter 362, so that fine particles generated in the work space 342 do not leak out to the outside 90. Of course, in the isolator 340, fine particles in the work space 342 do not leak out into the interior 22 of the clean room 320.

[0086] In the clean room system 310, the work space supply air path is flow path 350a, the work space exhaust paths are flow paths 350c, 350d, 350e, and 350f, and the room exhaust paths are flow paths 350a, 350b, 350c, 350d, 350e, and 350f, and the common exhaust path coincides with the work space exhaust path.

[0087] The exhaust fan 360 is provided in the common exhaust path. It drives the supply air in the working space air supply path and drives the exhaust air in the working space exhaust path and the room exhaust path. In the clean room system 310, no air is exhausted to the outside 90 except for the exhaust air from the flow path 350f. Therefore, the exhaust fan 360 drives all the exhaust air of the clean room system 310. In addition, the HEPA filter 362 is provided in the common exhaust path and purifies all the exhaust air. A simple exhaust structure is also realized in the third embodiment.

[0088] (4) Fourth embodiment A clean room system 410 according to the fourth embodiment will be described with reference to Fig. 7. Fig. 7 is a side view according to the fourth embodiment. In Fig. 7, the same or substantially similar parts as those in Fig. 6 (side view according to the third embodiment) are denoted by the same reference numerals, and the description thereof will be simplified or omitted.

[0089] In the clean room system 410, a clean room 420 includes an air supply unit 30 and an isolator 340. The isolator 440 has a configuration substantially similar to that of the isolator in the third embodiment shown in FIG.

[0090] The fourth embodiment differs from the third embodiment in the presence of a flow path 450g. The flow path 450g is located above the working space 342 and extends substantially horizontally in the front-rear direction of the isolator 440. The front end of the flow path 450g is open to the interior 22 of the clean room 420. The rear end of the flow path 450g is connected to the upper end of the flow path 450d1 and the lower end of the flow path 450d2.

[0091] In the isolator 440, air flows in the same manner as in the isolator 340 of the third embodiment. That is, air in the interior 22 of the clean room 420 is supplied to the working space 342 through the flow path 350a. Then, the air in the working space 342 is exhausted to the outside 90 through the flow paths 350c, 450d1, 450d2, 350e, and 350f. This exhaust air is driven by the exhaust fan 360 and cleaned by the HEPA filter 362.

[0092] Also, a flow is generated from the interior 22 of the clean room 420, which passes through the flow paths 450g, 450d2, 350e, and 350f as exhaust paths and is exhausted to the outside 90 without passing through the working space 342. This is because the flow path 450g forms a detour that merges with the communication point of the flow paths 450d1 and 450d2 without passing through the working space 342. The exhaust air passing through the flow path 450g is also driven by the exhaust fan 360 and cleaned by the HEPA filter 362. The amount of exhaust air passing through the flow path 450g can be adjusted, for example, by the cross-sectional area of ​​the flow path 450g, and can also be variably controlled by providing a movable valve in the flow path 450g.

[0093] In the fourth embodiment, the working space air supply path is the flow path 350a, and the working space exhaust path is the flow path 350c, 450d1, 450d2, 350e, 350f. There are two room exhaust paths, one is the flow path 350a, 350b, 350c, 450d1, 450d2, 350e, 350f, and the other is the flow path 450g, 450d2, 350e, 350f. The common exhaust path common to all the room exhaust paths and the working space exhaust paths is the flow path 450d2, 350e, 350f. No other exhaust paths are provided. The exhaust fan 360 and the HEPA filter 362 are provided in the common exhaust path, and drive and purify all the exhaust, respectively.

[0094] (5) Fifth embodiment A clean room system 510 according to the fifth embodiment will be described with reference to Fig. 8. Fig. 8 is a side view according to the fifth embodiment. In Fig. 8, the same or substantially similar parts as those in Fig. 3 (side view according to the first embodiment) are denoted by the same reference numerals, and the description thereof will be simplified or omitted.

[0095] In the clean room system 510 according to the fifth embodiment, unlike the clean room system 10 according to the first embodiment, an air supply fan is not provided in the air supply unit 530. The air supply unit 530 is merely provided with a HEPA filter 532.

[0096] In the clean room system 510, the amount of air in the interior 22 of the clean room 520 is reduced by exhausting air from the exhaust fan 60, creating a negative pressure. The exhaust fan 60 increases the degree of negative pressure in the interior 22 by operating at a high power. As a result, the required amount of air 570 flows from the outside 90 into the interior 22, overcoming the air resistance in the HEPA filter 532 installed in the room's air supply path. In other words, the air supply in the clean room system 510 is driven by the pressure difference between the interior 22 and the outside 90 of the clean room 520. As far as this air supply part is concerned, no power is used, and it can be called a natural air supply.

[0097] In the fifth embodiment, the exhaust structure is simply configured as in the first embodiment, and the room air supply path is a natural air supply path. Therefore, the clean room system 510 may be able to reduce manufacturing costs or maintenance costs.

[0098] (6) Sixth embodiment As mentioned above, negative pressure clean room systems have a biohazard countermeasure function that prevents or reduces the escape of fine particles generated in the work space. For this reason, negative pressure clean room systems are often used when handling materials that have a negative effect on the human body or the environment. Handling of work objects includes collection, testing, inspection, processing, manufacturing, etc.

[0099] Examples of work objects that require biohazard countermeasures include radioactive materials. Radioactive pharmaceuticals are pharmaceuticals that use radioactive materials. Chemical substances with toxicity or high physiological activity are also work objects that require hazard countermeasures. Anticancer drugs are an example of chemical substances with high physiological activity. Furthermore, biological objects are work objects that require biohazard countermeasures. Here, biological objects refer to all or part of a living organism (including viruses), or objects derived from a living organism that have been processed. Examples of biological objects include human, animal, or microbial tissues, cells, or nucleic acids, or processed products of these. Samples such as blood are also examples of biological objects. Samples that are infected with highly transmissible infectious diseases that have a large impact on public health are in high need of hazard countermeasures. Antibody drugs, nucleic acid drugs, and regenerative medicine products are also examples of biological objects. Biological objects require biohazard countermeasures for reasons such as the risk of containing infectious or pathogenic substances.

[0100] In the sixth embodiment, a use of a clean room system in the field of regenerative medicine relating to autologous cell transplantation will be described as an example where biohazard countermeasures are required.

[0101] Fig. 9 is a diagram illustrating a network 600 according to the sixth embodiment. The network 600 shown in Fig. 9 connects transportation-related facilities for a regenerative medical product 602. The network 600 includes a CPC 604, a cell preparation facility 606, a cell preparation vehicle 608, and hospitals 610a, 610b, 610c, and 610d (some or all of these may be referred to as hospitals 610).

[0102] CPC604 is a Cell Processing Center, and is also called CPF (Cell Processing Facility). CPC604 is equipped with a clean room, and processes cells collected from a patient to manufacture a regenerative medicine product 602. A clean room system such as that exemplified in the first to fifth embodiments can be introduced into CPC604. However, CPC604 is a relatively large facility, and may be equipped with multiple large clean rooms or multiple biohazard cabinets within the clean room. For this reason, in addition to the biohazard cabinets, an exhaust mechanism may be provided in the clean room itself in the clean room of CPC604.

[0103] The cell preparation facility 606 is a facility provided between the CPC 604 and the hospital 610. In the cell preparation facility 606, cell preparation and transportation are performed for cells collected from patients or for manufactured regenerative medical products 602. The cell preparation facility 606 is installed inside a building, and is equipped with a clean room system 606a as exemplified in the first to fifth embodiments. Cell preparation is performed using the working space of a hazard control cabinet installed in the clean room system 606a. Note that cell preparation broadly refers to a process that changes the state of cells, or a process that tests or inspects the state of cells.

[0104] The cell preparation vehicle 608 is a vehicle that is located between the CPC 604 and the hospital 610 and is used for cell preparation and transportation of cells collected from a patient or manufactured regenerative medical products. The cell preparation vehicle 608 is formed by mounting a clean room system 608a as exemplified in the first to fifth embodiments on a self-propelled vehicle equipped with an electric motor, an internal combustion engine, or the like.

[0105] The hospital 610 is a facility where regenerative medicine practitioners, such as doctors, dentists, and veterinarians, diagnose and treat patients. It is assumed that the hospitals 610a to 610d have been established by different organizations and are located in buildings in different locations. The hospital 610 performs regenerative medicine related to autotransplantation. Doctors and dentists are in charge of collecting tissues or cells from patients and transplanting regenerative medicine products 602 into the patients.

[0106] In the sixth embodiment, it is assumed that the number of hospitals 610 is the largest, followed by the number of cell preparation facilities 606 or cell preparation vehicles 608, and the number of CPCs 604 is the smallest. The CPC 604 provides services to a plurality of hospitals 610 via a plurality of cell preparation facilities 606 or cell preparation vehicles 608. The cell preparation facilities 606 or cell preparation vehicles 608 each provide services to a plurality of hospitals 610. Of course, it is possible for a certain hospital 610 to use a plurality of cell preparation facilities 606 or cell preparation vehicles 608, and it is also possible for a certain cell preparation facility 606 or cell preparation vehicle 608 to use a plurality of CPCs 604.

[0107] When regenerative medicine involving autologous transplantation is performed, cells are first collected from one or more target patients at a hospital 610. For the collection, staff from the cell preparation facility 606 or cell preparation vehicle 608 go to the hospital 610 to assist with the collection. Examples of assistance with collection include inputting patient information, cell information, and the like into a computer, storing the collected cells in a container with controlled temperature and cleanliness, and arranging the transplant date and time.

[0108] The staff brings the collected cells back to the cell preparation facility 606 or the cell preparation vehicle 608. Then, the necessary cell preparation is performed using the clean room systems 606a and 608a. Examples of cell preparation include one or more processes selected from cell washing, drug addition, refrigeration, freezing, container storage, and infectious specimen testing including sterility testing.

[0109] The staff transports the cells stored in the container to CPC 604. The staff may request a transport company or staff of CPC 604 to transport the cells, or may transport the cells themselves. The cells may be transported individually for each person, or multiple cells may be transported together.

[0110] The CPC 604 manufactures a regenerative medicine product 602 from the received cells. In the manufacturing process, for example, cell culture is performed using a manufacturing device installed in a clean room. The manufactured regenerative medicine product 602 is transported in a frozen state to a cell preparation facility 606 or a cell preparation vehicle 608.

[0111] In the cell preparation facility 606, the received regenerative medicine product 602 is stored in a storage facility where the cleanliness and temperature are controlled. The storage facility may be provided inside the clean room systems 606a and 608a or may be provided outside.

[0112] The regenerative medicine product 602 is taken out from the storage at a timing calculated backwards from the date and time of transplantation in the hospital 610. Then, cell preparation is carried out in the clean room systems 606a and 608a. Examples of cell preparation include one or more processes selected from thawing, heating, activation, drug addition, container storage, and testing including sterility testing.

[0113] Staff at the cell preparation facility 606 or cell preparation vehicle 608 deliver the regenerative medicine product 602 after cell preparation to a hospital 610. If necessary, the staff also assists in transplanting the regenerative medicine product 602. An example of the assisting work is matching the patient information, cell information, etc. registered in a computer with the patient and the regenerative medicine product 602.

[0114] In this way, the staff of the cell preparation facility 606 and the cell preparation vehicle 608 go to multiple hospitals 610 to support regenerative medicine. Therefore, it is convenient for the cell preparation facility 606 to be installed in a neighborhood where there are two or more, three or more, four or more, or five or more hospitals 610 that are customers. Here, the range of "nearby" can be defined as the one-way travel time between the patient's treatment location in the hospital 610 and the clean room system 606a of the cell preparation facility 606. Specifically, the travel time can be exemplified as a range of 90 minutes or less, 60 minutes or less, 40 minutes or less, 30 minutes or less, 20 minutes or less, 10 minutes or less, or 5 minutes or less. The travel time is measured as the time required by a commonly used means of transportation selected from walking, bicycle, motorcycle, car, bus, train, etc. In order to level out variations due to waiting time at traffic lights and operating intervals of public transportation, the travel time is measured as the average time required when traveling multiple times on the day of the week and time period in which transportation is performed. The range of "vicinity" can also be defined based on the travel distance or straight-line distance along the above-mentioned transportation means between the patient's treatment location in the hospital 610 and the clean room system 606a of the cell preparation facility 606. Specifically, examples of the range include travel distances or straight-line distances within 20 km, within 15 km, within 10 km, within 8 km, within 6 km, within 2 km, within 1 m, or within 500 m.

[0115] The cell preparation vehicle 608 can move to the hospital 610 under its own power. However, the size of the clean room system 608a that can be mounted on the cell preparation vehicle 608 is limited. If the mounting space of the vehicle is large, it is possible to provide a buffer room in the clean room system 608a, but in order to save space, it is also possible to provide only the clean room without providing a buffer room. The clean room system 608a is generally used when the cell preparation vehicle 608 is stopped, but is also designed to be usable when the vehicle is moving.

[0116] The clean room systems 606a, 608a provided in the cell preparation facility 606 and the cell preparation vehicle 608 are equipped with the above-mentioned simple exhaust mechanism. Therefore, the manufacturing costs or maintenance costs required for the exhaust mechanism can be reduced compared to a general clean room installed in a CPC 604, etc. Since the cell preparation facility 606 and the cell preparation vehicle 608 need to be installed in greater numbers than the CPC 604, it is highly worthwhile to introduce the low-cost clean room systems 606a, 608a.

[0117] In the above explanation, a regenerative medical product 602 for autologous transplantation has been given as an example. The network configuration in which a CPC 604 provides cells to a hospital 610 via a cell preparation facility 606 or a cell preparation vehicle 608 can also be widely applied to regenerative medical products for allogeneic transplantation. Regenerative medical products for allogeneic transplantation are manufactured in a CPC using cells and the like derived from a patient other than the transplant recipient, and are stored in a storage facility as necessary.

[0118] In the above description, the cell preparation facility 606 and the cell preparation vehicle 608 are facilities that support a plurality of hospitals 610. Alternatively, the cell preparation facility 606 or the cell preparation vehicle 608 may be facilities that belong exclusively to each hospital 610. In the case of an exclusive facility, the cell preparation facility 606 may be provided in the vicinity of the hospital 610, more so than in the above example. Specifically, the vicinity may be a location where the travel time from the cell preparation facility 606 to the treatment location is within 10 minutes, within 5 minutes, within 3 minutes, or within 1 minute. In addition, the vicinity may be a location where the cell preparation facility 606 is connected to the treatment location, in the same site, in the same building, or on the same floor level in the same building. When the cell preparation facility 606 or the cell preparation vehicle 608 is provided in each hospital 610, the number of clean room systems 606a and 608a installed is also increased, and therefore, there is a great advantage in adopting an exhaust structure that can be installed or maintained at low cost. [Explanation of symbols]

[0119] 10 clean room system, 20 clean room, 22 inside, 24 buffer room, 26 outer door, 28 inner door, 30 air supply unit, 32 HEPA filter, 34 air supply fan, 40 safety cabinet, 42 work space, 44 front opening, 46 HEPA filter, 50a, 50b, 50c, 50d, 50e, 50f flow path, 60 exhaust fan, 62 HEPA filter, 70a, 70b, 70c air, 90 outside, 100 UI, 102 outdoor pressure sensor, 104 indoor pressure sensor, 106 indoor temperature sensor, 107 indoor particle sensor, 108 work space particle sensor, 110 control device, 112 recording unit, 114 calculation unit, 116 operation mode table, 210 clean room system, 220 clean room, 240 Safety cabinet, 250a, 250b, 250c, 250d, 250e, 250f Flow path, 260 Exhaust fan, 261 Exhaust unit, 262 HEPA filter, 264 Work space air supply fan, 310 Clean room system, 320 Clean room, 340 Isolator, 342 Work space, 344 Glove box, 350a, 350b, 350c, 350d, 350e, 350f Flow path, 360 Exhaust fan, 362 HEPA filter, 370b Air, 410 Clean room system, 420 Clean room, 440 Isolator, 450d1, 450d2, 450g Flow path, 470b Air, 510 Clean room system, 520 Clean room, 530 Air supply unit, 532 HEPA filter, 570 Air, 600 Network, 602 regenerative medicine products, 604 CPC, 606 cell preparation facilities, 606a clean room systems, 608 cell preparation vehicles, 608a clean room systems, 610,610a,610b,610c,610d hospitals.

Claims

1. An airtight clean room; a room air supply path for supplying air from the outside of the clean room to the inside of the clean room; a hazard control cabinet installed inside the clean room, the cabinet comprising: a work space; a work space air supply path which supplies air from inside the clean room to the work space; a circulation path which takes in air from the work space and supplies it again to the work space; a work space exhaust path which has a common part with the circulation path and which branches off midway through the circulation path to the outside and which exhausts air from the work space to the outside of the clean room; an exhaust fan which is installed in the common part of the circulation path and the work space exhaust path or at a location where both branch off, and which drives circulation in the circulation path and exhaust in the work space exhaust path; and a filter which is installed in the work space exhaust path and purifies the exhaust air; Equipped with No other fan is provided in the circulation path between the location where the exhaust fan is provided and the working space, A clean room system characterized in that the exhaust fan, which drives circulation in the circulation path and exhaust in the work space exhaust path, drives total exhaust from the inside of the clean room to the outside and maintains the inside of the clean room at negative pressure.

2. 2. The clean room system according to claim 1, a bypass passage communicating with the work space exhaust passage from inside the clean room without passing through the work space, A clean room system characterized in that the exhaust fan also drives air flowing through a bypass passage.

3. 2. The clean room system according to claim 1, The hazard control cabinet is a safety cabinet, A clean room system, characterized in that the work space is a space where work on biological objects is carried out.

4. 2. The clean room system according to claim 1, A clean room system characterized in that the room air supply path is a natural air supply path that supplies air using the negative pressure inside the clean room created by the exhaust fan as a driving force.

5. 2. The clean room system according to claim 1, The working space is a space where work is performed on regenerative medical products manufactured in a cell culture processing facility, The clean room system is characterized in that it is installed near a treatment location where the regenerative medical product is used.

6. 6. The clean room system according to claim 5, The treatment locations are distributed across two or more buildings; The clean room system is characterized in that it is installed in a location close to the treatment location in at least two or more buildings.

7. The clean room system according to claim 1 ; A vehicle carrying the clean room; Equipped with The working space is a space where work is performed on regenerative medical products manufactured in a cell culture processing facility, A vehicle equipped with a clean room system, characterized in that the vehicle is capable of being moved to the vicinity of a treatment location where regenerative medical products are used.

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