Clean room system and clean room system mounting vehicle

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 maintained 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, leakage of air containing suspended particles such as infectious substances present inside the clean room to the outside can be reduced or prevented.

[0003] Clean rooms are sometimes equipped with devices such as safety cabinets that provide a workspace for handling infectious materials and other work objects. In many cases, the safety cabinet controls the air intake and exhaust in the workspace by itself.

[0004] Non-Patent Document 1 is the Japanese Industrial Standard JIS for safety cabinets and similar devices. These devices are called biohazard cabinets and are classified into Class I, Class II, and Class III depending 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, commonly called a draft chamber, draws in air from the front opening and supplies it to the workspace without purification, and filters and exhausts the exhaust air from the workspace before discharging it. Class II equipment, commonly called a safety cabinet, draws in air from the front opening and supplies it to the workspace. The circulating air is filtered and supplied to the workspace, and then exhausted from the workspace, repeating this process. During this process, some of the air is filtered and then exhausted to the outside. In equipment without a circulation path, air is drawn in separately from outside and filtered before being supplied to the workspace. The air supplied to the workspace and the air supplied from the front opening are combined and filtered before being exhausted to the outside. Class III equipment, commonly called an isolator, draws in air from outside and filters it before being supplied to the workspace, and exhausts the exhaust air from the workspace before being exhausted to the outside. Although this standard is called "bio," it is not limited to applications in the bio field, but has also been formulated with consideration given to applications involving the handling of other substances, such as volatile substances.

[0006] Patent Document 1 listed below describes a negative pressure clean room formed by combining partitions. This clean room is used for biological applications and has a safety cabinet installed inside. In this clean room, the clean room itself and the safety cabinet's supply and exhaust systems 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. 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 relates to a slightly positive pressure, open clean room (referred to as a clean booth in this document) using an airflow barrier system equipped with a safety cabinet or the like. A doorless, always-open entrance / exit is provided in the wall of the clean room, and an air supply fan is provided in the ceiling. Air is supplied to the interior of the clean room by the air supply fan. In the safety cabinet, a fan provided in the safety cabinet supplies air from within the clean room, flows it into the work space, and then exhausts the air from the safety cabinet to the interior of the clean room. The air inside the clean room then flows in one direction toward the entrance / exit and is exhausted to the outside of the clean room.

[0008] Patent Document 3 listed below 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 and processing facility (referred to in the document as a CPF) and returned to the academia, where they are used for transplantation into patients. 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 U.S. regulations (e.g., paragraphs 0012 to 0018). Therefore, this document proposes establishing a CGMP-grade facility near the patient's location for treatment and implementing the necessary management, etc. (e.g., paragraphs 0019, 0089 to 0118).

[0009] When performing regenerative medicine, it is necessary to comply with the laws and regulations of the country or region where the treatment is being performed. In Japan, the law in Non-Patent Document 2 defines "regenerative medicine products" as follows: "The following items (excluding quasi-drugs and cosmetics) as specified by government ordinance: 1. Items intended for use in the following medical or veterinary care, which have been 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 human or animal disease; 2. Items intended for use in the treatment of human or animal disease, which contain genes introduced into human or animal cells and expressed in the body." Furthermore, 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] Japanese Patent Application Laid-Open No. 2005-326093 [Patent Document 2] Japanese Patent Application Laid-Open No. 2019-100594 [Patent Document 3] U.S. Patent Publication No. 2003-0175242A1 [Non-patent literature]

[0011] [Non-Patent Document 1] JIS K3800 Biohazard Class II Cabinets Revised July 20, 2021 [Non-patent document 2] Japan's "Act on Ensuring Quality, Efficacy 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 for a simple configuration of a negative pressure clean room. However, the clean room of Patent Document 1 is equipped with an exhaust fan that exhausts air from the inside of the clean room to the outside and a local exhaust fan that exhausts air from the inside of 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, providing redundant exhaust structure. Patent Document 2 describes a simple exhaust structure, but this is merely a configuration specific to a positive pressure 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] Furthermore, in order to facilitate the smooth implementation of regenerative medicine, there is a need to establish clean rooms for handling cells in or near hospitals where patients receive treatment, etc. However, Patent Document 3 does not take into consideration the costs of setting up or maintaining the facilities.

[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 the vicinity thereof. [Means for solving the problem]

[0016] The clean room system of the present invention comprises an airtight clean room, a room air supply path that supplies air from the outside of the clean room to the inside, a work space, a work space air supply path that supplies air from the inside of the clean room to the work space, a work space exhaust path that exhausts air from the work space to the outside of the clean room, an exhaust fan that is provided in the work space exhaust path and drives the exhaust, 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, wherein the exhaust fan drives all 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 workspace is a space where workers or equipment work on work objects. A hazard control cabinet is a device that provides a workspace with controlled air intake and exhaust and prevents hazards caused by particles generated in the workspace. 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 structure of Class I, II, or III described in Non-Patent Document 1. Hazard control cabinets also include those that do not meet the numerical, configuration, and material requirements specified in Non-Patent Document 1, but that can implement the overall level of hazard control required by the user.

[0018] Maintaining a negative pressure inside a clean room means controlling the air pressure inside the clean room to a value lower than the external air pressure on a time-averaged basis, or ensuring that the airflow is directed from the outside to the inside of the clean room on a time-averaged basis. Because air pressure fluctuates both temporally and spatially due to factors such as fan operation and turbulence, time averaging can be used to smooth out these fluctuations and evaluate the clean room's internal pressure. The time averaging period depends on the response speed of the air pressure sensor, but could be, for example, 60, 30, or 10 seconds. The direction of the airflow can be confirmed using a smoke test. The pressure difference between the inside and outside of the clean room can be set to various values, including 30 Pa, 20 Pa, 10 Pa, 5 Pa, 3 Pa, and 1 Pa. The pressure difference can be set to a level that reduces or prevents the leakage of air particles from the inside to the outside of the clean room. The pressure difference can also be set taking into consideration the ease of opening and closing the entrance and exit doors, the suppression of wind noise, the power consumption of the fan, or the ventilation of the filter. If the pressure difference is small, there may be a situation where 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 kept to a small amount and the clean room system can maintain a level that allows hazard control, this short-term 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. These components are inseparable parts that are closely related to the air supply and exhaust in the clean room itself. In this respect, the clean room and the hazard control cabinet can be considered to be integrally configured. Therefore, some or all of these components may not be considered to belong to the hazard control cabinet, but may be listed in product catalogs as parts provided in the clean room or as separately provided parts. Even in such cases, if these components are necessary elements to realize a biohazard control cabinet, they can be considered to constitute components of the hazard control cabinet and satisfy the constituent requirements of this invention.

[0020] In one aspect of the present invention, a bypass passage is provided that connects the inside of the clean room to the work space exhaust path without passing through the work space, and the exhaust fan also drives the air that flows through the bypass passage. In another aspect, no bypass passage is 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 on biological objects is performed. Safety cabinets include, but are not limited to, those that meet the biohazard control cabinet Class II standard in Non-Patent Document 1. Even if a cabinet does not meet the requirements of Non-Patent Document 1, such as the numerical values, configuration, and materials, it is acceptable as long as it can implement biohazard control at the overall level required by the user.

[0022] In one aspect of the present invention, 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.

[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 classified as pharmaceuticals, quasi-drugs, cosmetics, veterinary medicines, etc. by law. Similarly, treatment site refers not only to the location where a patient is treated, but also to the location where a treatment is performed on a person or animal that is not considered medical treatment by law.

[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 close 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 being capable of moving to the vicinity of treatment locations where the regenerative medical products are used. [Effects of the Invention]

[0028] A clean room system that can reduce manufacturing costs or maintenance costs is realized. [Brief explanation of the drawings]

[0029] [Figure 1] 1 is a perspective view of a clean room system according to a first embodiment. FIG. [Figure 2] FIG. 1 is a top view of a clean room system according to a first embodiment. [Figure 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. [Figure 5] FIG. 10 is a side view of the clean room system according to the second embodiment. [Figure 6] FIG. 10 is a side view of the clean room system according to the third embodiment. [Figure 7] FIG. 10 is a side view of the clean room system according to the fourth embodiment. [Figure 8] FIG. 10 is a side view of the clean room system according to the fifth embodiment. [Figure 9] FIG. 10 is a diagram illustrating an example of use of the clean room system according to the sixth embodiment. DETAILED DESCRIPTION OF THE INVENTION

[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 implemented in various forms. Also, it should be noted that each drawing is a schematic diagram simply showing the features of the embodiment, and the structure and scale are not necessarily accurate.

[0031] (1) First embodiment 1, 2 and 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 equipped with a floor, walls, and ceiling, and maintains an airtight interior 22. Airtightness refers to a state in which the air flow between the interior 22 and the exterior 90 is reduced or blocked, and airtightness refers to the property of maintaining a space airtight. The airtightness of the clean room 20 allows for the control of 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 components produced in a quality-controlled factory. It is also possible to form some or all of the walls, floor, and ceiling of the clean room 20 using 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 where cleanliness is not controlled, or may be another clean room where cleanliness is controlled. The clean room 20 can also be installed outdoors, with its exterior surface exposed to the outdoors. 1 to 3, the clean room 20 is illustrated assuming that it is approximately 3 m in each of two horizontal directions and approximately 2 m in height. However, the size can be set to various values, 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 clean room 20 and a buffer room 24 adjacent to the clean room 20. The buffer room 24 is located between the interior 22 and the exterior 90 of the clean room 20 and serves as a buffer space when workers enter and exit the clean room 20 or when work objects are brought in and out. The buffer room 24 includes an outer door 26 and an inner door 28. The outer door 26 is used for access between the exterior 90 and the buffer room 24, and the inner door 28 is used for access between the buffer room 24 and the interior 22 of the clean room 20. The outer door 26 and the inner door 28 are controlled so that they cannot be opened simultaneously, preventing direct ventilation between the interior 22 of the clean room 20 and the exterior 90. Furthermore, the provision of the buffer room 24 reduces changes in air pressure in the interior 22 of the clean room 20 when workers enter and exit, thereby suppressing air turbulence.

[0035] In the clean room 20, an air supply unit 30 and a safety cabinet 40 are provided as devices that constitute 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 (referred to as the "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 on the ceiling of the clean room 20. The air supply unit 30 is a unitized device that combines a HEPA filter 32 and an air supply fan 34, and is detachably attached to the room air supply path. The HEPA filter 32 is a filter that removes fine particles in the air in accordance with the HEPA (High Efficiency Particulate Air) standard. The HEPA filter 32 is detachably attached to the air supply fan 34. Therefore, 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 intake fan 34 is a device equipped with a fan for supplying air. The term "fan" broadly refers to devices that drive air, and includes various structures such as propeller fans, centrifugal fans, and hybrid fans that combine these. The intake fan 34 receives 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, removing fine particles contained in the air from the outside 90.

[0038] The safety cabinet 40 is an open-type hazard control cabinet equipped with a front opening 44. The safety cabinet 40 is installed near a wall surface far from the buffer room 24 in the interior 22 of the clean room 20. The safety cabinet 40 is equipped with a work 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 is sometimes called a work hood, work chamber, etc. The work space 42 is provided inside the safety cabinet 40 in a roughly rectangular parallelepiped shape. A HEPA filter 46 is provided on the top surface of the work space 42. The front wall 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 forms 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 its periphery.

[0040] The front opening 44 is a part that communicates with the interior 22 of the clean room 20, and is used by workers to put in and take out their arms and work objects, as well as being used as a flow path to supply 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 work space 42. The HEPA filter 46 is a filter that purifies the air supplied to the work 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 known as aseptic processing to be performed in the work space 42.

[0042] As shown in FIG. 3, connected air flow paths 50a to 50f are installed around the work space 42. The flow path 50a is provided below the work space 42 and is connected to a hole provided in the bottom surface of the work space 42. The flow path 50a extends approximately horizontally in the front-to-rear direction of the safety cabinet 40. The flow path 50b is provided at the rear of the work space 42 and is a flow path extending in the up-down direction (vertical direction). The lower end of the flow path 50b is connected to the rear end of the flow path 50a. The flow path 50c is a flow path located on an extension of the flow path 50b and extends in the up-down direction. The lower end of the flow path 50c is connected to 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 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] Flow path 50e is located above the work space 42 and extends approximately horizontally in the front-to-rear direction of the safety cabinet 40. The rear end of flow path 50e is connected to the upper end of flow path 50b via the exhaust fan 60, and the front end of flow path 50e is connected to the upper surface of the HEPA filter 46. Flow path 50f is an air flow path in the work space 42 and flows approximately uniformly downward through the work space 42. The upper end of flow path 50f is connected to the lower surface of the HEPA filter 46 and is connected to the front end of flow path 50e via the HEPA filter 46. The lower end of flow path 50f is connected to flow path 50a via a hole provided in the bottom surface of the work space 42. In addition, the front lower portion of flow path 50f is connected to the interior 22 of the clean room 20 (and the outside of the safety cabinet 40) via the front opening 44. Some or all of the flow paths 50a to 50e can be formed using, for example, tubular ducts or plate-like members. In this embodiment, the flow paths 50a to 50e are attached to a frame that constitutes the safety cabinet 40, and are further covered with the cover of the safety cabinet 40, so that they are formed integrally with the safety cabinet 40.

[0044] The exhaust fan 60 is provided at a location where the flow paths 50b, 50c, and 50d communicate with each other. The exhaust fan 60 has a fan that drives air and is powered by electricity. The exhaust fan 60 draws air from the flow path 50b, distributes it to the flow paths 50c and 50d, and discharges it. The distribution ratio may be constant or may be variably controlled using, for example, an electrically operated movable valve.

[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 that is discharged from the inside 22 of the clean room 20 to the outside 90 to a level that can prevent or reduce hazards.

[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, a worker enters the interior 22 of the clean room 20 from the outside 90 via the buffer room 24. At this time, the worker first opens the outer door 26, enters the buffer room 24, and closes the outer door 26. If the buffer room 24 is used as a changing room, the worker puts on prescribed clothing, etc. Next, the worker opens the inner door 28, enters the interior 22 of the clean room 20, and closes the inner door 28. The outer door 26 and 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 in 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 interior 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 interior 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. Air 70c is then 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, air is driven by the exhaust fan 60 (of course, the air supplied by the supply fan 34 also indirectly drives the air). The functions of the exhaust fan 60 can be classified into the following three: the first is to supply air from the interior 22 of the clean room 20 to the work space 42; the second is to circulate air inside the safety cabinet 40; and 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 originates from the interior 22, passes through the front opening 44, the lower front part of the work space 42 (which is also the lower front part of flow path 50f), flow paths 50a, 50b, and 50e, and is then 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 to purify the air supplied to the work space 42.

[0053] In the second circulation, air flows through a circulation path consisting of flow path 50e, flow path 50f (work space 42), flow path 50a, and 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 work space 42 is greater than the amount of air supplied to the work 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 work space 42 is under negative pressure due to a lack of air, and air is continuously sucked into the front lower part of the work space 42 through the front opening 44. The continuous suction flow formed at the front opening 44 reduces or prevents particles dispersed inside the work space 42 from leaking into the interior 22 of the clean room 20.

[0055] The third exhaust can be considered from two perspectives. One is the perspective of exhaust from the work space 42 to the outside 90. From this perspective, air flows through an exhaust path (called the "work space exhaust path") that starts from the work space 42 and passes through flow paths 50a, 50b, 50c, and 50d to the outside 90. The other is the perspective of exhaust from the interior 22 of the clean room 20 to the outside 90. From this perspective, air flows through an exhaust path (called the "room exhaust path") that starts from the interior 22, passes through the front opening 44, the front lower part of the work space 42 (the front lower part of flow path 50f), and passes through flow paths 50a, 50b, 50c, and 50d to the outside 90. The flow path (called the "common exhaust path") that is common to the work space exhaust path and the room exhaust path is 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 drawn in through the flow path 50b into 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 through the front opening 44 but has not yet flowed through the work space 42. The latter air originates from the interior 22 of the clean room 20, passes through a "detour path" consisting of the front opening 44 and the lower front part of the work space 42, and joins the work space exhaust path, thereby bypassing the work space 42 and being exhausted directly to the outside 90. The combination of the detour path and the common exhaust path constitutes the room exhaust path. The flow through the detour path is driven by the exhaust fan 60.

[0057] The HEPA filter 62 purifies the air flowing in from the flow path 50c, reducing the number of particles in the air to a standard value or less, and then flows the purified air into the flow path 50d. This reduces or prevents particles (including, for example, infectious microorganisms and viruses. The particles include not only the substances themselves but also aerosolized substances) that are the target of hazard control measures and that have been mixed in the workspace 42 from leaking out to the outside 90.

[0058] The exhaust air discharged to the outside 90 via the exhaust fan 60 is the total exhaust air discharged from the interior 22 of the clean room 20 to the outside 90. Here, "total exhaust air" refers to the entire amount of exhaust air discharged from the clean room 20 as controlled during operation of the clean room system 10. This does not include air leaking through minute gaps in the walls of the clean room 20, turbulent backflow from the air supply unit 30, or air leaking from the buffer room 24 when workers enter or exit the room. In the clean room system 10, the exhaust fan 60 drives all exhaust air, simplifying the exhaust structure and reducing manufacturing and maintenance costs. Furthermore, the clean room system 10 potentially reduces manufacturing and maintenance costs by reducing the number or locations of HEPA filters 62 installed in the common exhaust path.

[0059] In the clean room system 10, the interior 22 of the clean room 20 is maintained at a negative pressure. In a negative pressure clean room 20 in which the interior 22 is maintained at a 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 particulates generated during work in the work space 42 to the outside 90.

[0060] The exhaust fan 60 is operated with enough power 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 intake fan 34. Therefore, the clean room system 10 monitors various conditions and controls the exhaust fan 60 and the intake fan 34.

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

[0062] The UI 100 is a user interface equipped with an input unit and a display unit formed by a touch panel display or the like. The UI 100 may be installed, for example, near the entrance to the clean room 20, or may be implemented in a terminal that can be carried by an operator. The display unit of the UI 100 displays the operating status of the clean room system 10, and the input unit accepts various inputs from the user. Examples of inputs include inputs to start and stop the clean room system 10, inputs to set the operating power when the workspace 42 is in use and when it is not in use, and inputs 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 of the clean room 20 and in workspace 42, and measure particles suspended 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, memory, etc., using embedded software. The control device 110 includes a recording unit 112, a calculation unit 114, and an operation mode table 116 under the control of the embedded software. The recording unit 112 records the operating 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, as well as control status data in the control device 110. The calculation unit 114 switches the operating modes of the supply air fan 34 and the exhaust fan 60 according to the instruction data transmitted from the UI 100. The calculation unit 114 then 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 air supply 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, and a low-power mode. The operation modes can also include a power-saving mode in which the intake air fan 34 and the exhaust fan 60 are operated at a reduced power level when the safety cabinet 40 is not in use. The operation mode table 116 sets the numerical values ​​of the power at which the intake air fan 34 and the exhaust fan 60 should be operated in each operation mode.

[0066] The air supply 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 air supply 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 (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 particulates flowing from the exterior 90 into the interior 22 are reduced or prevented. When there is a need for operation at a 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 intake fan 34 and the exhaust fan 60 are controlled while monitoring various data. However, the intake fan 34 and the exhaust fan 60 can also be configured not to be controlled based on monitoring, as long as they operate to ensure the necessary negative pressure.

[0069] In addition, in the above description, the air intake and exhaust are performed from the ceiling portion, but one or both of the air intake 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 HEPA filters 32, 46, and 62 to purify the air. HEPA is a high-precision particulate filter whose specific performance is defined by standards such as JIS, ISO, and EN. The clean room system 10 installs the HEPA filters 32, 46, and 62 in accordance with the appropriate standards. By using HEPA, the required level of cleanliness can be ensured in most cases when the clean room system 10 is used. However, in the clean room system 10, some or all of the HEPA filters 32, 46, and 62 can be replaced with other filters depending on the required level of cleanliness. For example, a higher-performance filter (e.g., ULPA) or a lower-performance filter can be used instead of the HEPA. In addition to HEPA filters that utilize fineness of the filter, some also utilize static electricity to capture particulates. Electrostatic filters generally require continuous operation to constantly generate static electricity in order to continuously adsorb particulates. In the case of a type that uses static electricity, when the above-mentioned power saving mode is realized, for example, the intake and exhaust volume may be controlled to 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 entry, 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 used 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 through the front opening (corresponding to the workspace air supply path) is directly supplied to the workspace. A workspace exhaust path is also provided to exhaust the workspace air outside the clean room, and an exhaust fan and filter are installed in the workspace exhaust path. The flow path consisting of the front opening, workspace, and workspace exhaust path corresponds to the room exhaust path, and the workspace exhaust path coincides with the common exhaust path. By not providing any other exhaust paths leading to the outside of the clean room, a negative pressure clean room system can be formed in which the exhaust fan drives all exhaust and the filter purifies all 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 substantially similar to those in Fig. 3 (the side view according to the first embodiment) are denoted by the same reference numerals, and their description will be simplified or omitted.

[0075] In the clean room system 210, a 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 to 250f, an exhaust unit 261, and a work space air supply fan 264. The flow paths 250a to 250f are formed in approximately the same positions and with the same shapes as the flow paths 50a to 50f of the first embodiment, respectively.

[0076] However, the upper end of flow path 250b communicates with the lower end of flow path 250c and the rear end of flow path 250e. An exhaust unit 261 is detachably attached near the junction of 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 the exhaust air and is detachably attached to the exhaust unit 261. Therefore, when cleaning or replacing the HEPA filter 262, first remove the exhaust unit 261 and then remove the HEPA filter 262 from the exhaust unit 261. A workspace air supply fan 264 is provided near the front end of flow path 250e. The workspace air supply fan 264 is a fan that drives the supply of air to the workspace 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 of the work space 42 (the front lower part of the flow path 250f), 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 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 of the work space 42, and flow paths 250a, 250b, 250c, and 250d, and reaches the outside 90. The common exhaust path is a path consisting of flow paths 250a, 250b, 250c, and 250d. The circulation path is composed of the work space 42 (flow path 250f), and flow paths 250a, 250b, and 250e.

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

[0079] In the above description, an example was given in which only one safety cabinet 240 was installed inside the clean room 220. 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. The work space exhaust paths may be configured to communicate with the outside 90 separately without merging, and each may be provided with an exhaust fan and a filter. Alternatively, the work space exhaust paths may be merged so that the merged path communicates with the outside 90. When merging, an exhaust fan and a filter may be provided only in the merged path. When an exhaust fan is provided only in the merged path, a circulation fan may be provided in each hazard control cabinet to drive air circulation within 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, parts that are the same as or substantially similar to those in Fig. 3 (the side view according to the first embodiment) are designated by the same reference numerals, and their 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 in front of the isolator 340 instead of a front opening. The glove box 344 has a flexible groove that protrudes toward the work space 342. The gloves are airtight, and a worker putting his or her hands into the gloves can operate work objects inside the work space 342 from outside the work space 342.

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

[0083] Exhaust fan 360 is a fan that drives exhaust. Exhaust fan 360 is provided between flow path 350d and flow path 350e. HEPA filter 362 is a filter that purifies the exhaust. HEPA filter 362 is provided between flow path 350e and 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 flow path 350a. After flowing through flow path 350a, the air is purified by the HEPA filter 46, then flows through flow path 350b inside the work space 342, and enters flow path 350c through a hole in the bottom surface of the work space 342. The air that enters flow path 350c moves to flow path 350d, is sucked into the exhaust fan 360, and is discharged to flow path 350e. The air is then purified by the HEPA filter 362, passes through flow path 350f, and is exhausted to the outside 90.

[0085] Only air purified by the HEPA filter 46 flows into the work space 342 of the isolator 340, thereby achieving a high level of cleanliness. Furthermore, 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, the isolator 340 also prevents fine particles in the work space 342 from leaking 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 of air in the work space air supply path and the exhaust of air in the work 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 from the flow path 350f. Therefore, the exhaust fan 360 drives all exhaust of the clean room system 310. In addition, a HEPA filter 362 is provided in the common exhaust path and purifies all exhaust. A simple exhaust structure is also realized in the third embodiment.

[0088] (4) Fourth embodiment A clean room system 410 according to a fourth embodiment will be described with reference to Fig. 7. Fig. 7 is a side view according to the fourth embodiment. In Fig. 7, parts that are the same as or substantially similar to those in Fig. 6 (the side view according to the third embodiment) are denoted by the same reference numerals, and their description 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 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 approximately horizontally in the front-to-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 from the interior 22 of the clean room 420 is supplied to the working space 342 through a flow path 350a. Then, the air from the working space 342 is exhausted to the outside 90 through flow paths 350c, 450d1, 450d2, 350e, and 350f. This exhaust air is driven by an exhaust fan 360 and purified by a HEPA filter 362.

[0092] Furthermore, a flow of exhaust air is also generated from the interior 22 of the clean room 420, bypassing the working space 342 and passing through the flow paths 450g, 450d2, 350e, and 350f as exhaust paths to the outside 90. 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 purified by the HEPA filter 362. The amount of exhaust air passing through the flow path 450g can be adjusted by, for example, 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 work space air supply path is flow path 350a, and the work space exhaust paths are flow paths 350c, 450d1, 450d2, 350e, and 350f. There are two room exhaust paths: one is flow paths 350a, 350b, 350c, 450d1, 450d2, 350e, and 350f, and the other is flow paths 450g, 450d2, 350e, and 350f. The common exhaust path shared by all room exhaust paths and work space exhaust paths is flow paths 450d2, 350e, and 350f. No other exhaust paths are provided. An exhaust fan 360 and a HEPA filter 362 are provided on the common exhaust path, and respectively drive and purify all exhaust air.

[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, parts that are the same as or substantially similar to those in Fig. 3 (the side view according to the first embodiment) are denoted by the same reference numerals, and their description 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 increased power. As a result, the required amount of air 570 flows from the outside 90 into the interior 22, overcoming the air resistance of 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 configured simply as in the first embodiment, and the room air supply path is a natural air supply path, which may reduce the manufacturing cost or maintenance cost of the clean room system 510.

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

[0099] Examples of work objects requiring biohazard control include radioactive materials. Radioactive pharmaceuticals are pharmaceuticals that use radioactive materials. Toxic or highly physiologically active chemicals are also work objects requiring hazard control. Anticancer drugs are an example of highly physiologically active chemicals. Furthermore, biological objects are also work objects requiring biohazard control. 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. Blood specimens and other biological specimens are also examples of biological objects. Specimens containing highly contagious infectious diseases that have a significant impact on public health require hazard control measures. Antibody drugs, nucleic acid drugs, and regenerative medicine products are also examples of biological objects. Biohazard control measures are required for biological objects due to the risk of containing infectious or pathogenic substances.

[0100] In the sixth embodiment, a usage of a clean room system in the field of regenerative medicine related 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 regenerative medicine products 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 which may be referred to as hospitals 610).

[0102] CPC 604 is a cell processing center, sometimes called a CPF (cell processing facility). CPC 604 is equipped with a clean room and processes cells collected from a patient to manufacture regenerative medicine products 602. A clean room system such as that exemplified in the first to fifth embodiments can be installed in CPC 604. However, CPC 604 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 installed in the clean room itself in the clean room of CPC 604.

[0103] The cell preparation facility 606 is a facility located between the CPC 604 and the hospital 610. The cell preparation facility 606 performs cell preparation and transportation of cells collected from patients or manufactured regenerative medicine 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 workspace 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 patients or manufactured regenerative medicine products. The cell preparation vehicle 608 is formed by mounting a clean room system 608a such as those exemplified in the first to fifth embodiments on a self-propelled vehicle equipped with an electric motor or an internal combustion engine.

[0105] Hospital 610 is a facility where regenerative medicine practitioners, such as doctors, dentists, and veterinarians, diagnose and treat patients. Hospitals 610a to 610d are assumed to have been established by different organizations and are located in buildings in different locations. Hospital 610 performs regenerative medicine related to autologous transplantation. Doctors and dentists are responsible for collecting tissues or cells from patients and transplanting regenerative medicine products 602 into them.

[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 multiple hospitals 610 via multiple cell preparation facilities 606 or cell preparation vehicles 608. Furthermore, each cell preparation facility 606 or cell preparation vehicle 608 provides services to multiple hospitals 610. Of course, it is possible for a certain hospital 610 to use multiple 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 multiple 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, etc. into a computer, storing the collected cells in a temperature- and cleanliness-controlled container, and arranging the transplant date and time.

[0108] The staff brings the collected cells back to the cell preparation facility 606 or 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 the group consisting of cell washing, drug addition, refrigeration, freezing, container storage, and infectious specimen testing including sterility testing.

[0109] The staff transports the cells stored in the containers to CPC 604. The staff may request a transport company or staff at CPC 604 to transport the cells, or may do so themselves. The cells may be transported individually for one person, or in bulk for multiple people.

[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 manufacturing equipment 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] The cell preparation facility 606 stores the received regenerative medicine products 602 in a storage facility where cleanliness and temperature are controlled. The storage facility may be located inside the clean room systems 606a and 608a or outside.

[0112] The regenerative medicine product 602 is taken out from storage at a time calculated backward from the date and time of transplantation at the hospital 610. Then, cell preparation is carried out in 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 assist in transplanting the regenerative medicine product 602. An example of an assisting task is matching the patient and regenerative medicine product 602 with patient information, cell information, etc. registered in a computer.

[0114] In this way, staff of the cell preparation facility 606 and the cell preparation vehicle 608 travel to multiple hospitals 610 to provide regenerative medicine support. Therefore, it is convenient for the cell preparation facility 606 to be located in a neighborhood with two or more, three or more, four or more, or five or more customer hospitals 610. Here, the "neighborhood" range 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, examples of travel times include travel times within 90 minutes, 60 minutes, 40 minutes, 30 minutes, 20 minutes, 10 minutes, or 5 minutes. Travel time is measured as the time required by a commonly used means of transportation selected from walking, bicycle, motorcycle, car, bus, train, etc. To smooth out variations due to waiting times at traffic lights and the intervals between public transportation services, travel time is measured as the average travel time required for multiple trips on the day of the week and time period in which transportation is performed. The "vicinity" range 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 of 20 km or less, 15 km or less, 10 km or less, 8 km or less, 6 km or less, 2 km or less, 1 m or less, or 500 m or less.

[0115] The cell preparation vehicle 608 can move to the hospital 610 under its own power. However, there is a limit to the size of the clean room system 608a that can be mounted on the cell preparation vehicle 608. If the vehicle has a large mounting space, it is possible to provide a buffer room in the clean room system 608a, but to save space, it is also possible to provide only the clean room without a buffer room. The clean room system 608a is generally used when the cell preparation vehicle 608 is stopped, but it 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 general clean rooms installed in CPCs 604, etc. Since the cell preparation facility 606 and the cell preparation vehicle 608 need to be installed in greater numbers than CPCs 604, there is great value in introducing the low-cost clean room systems 606a, 608a.

[0117] The above explanation has taken the example of a regenerative medicine product 602 for autologous transplantation. The network configuration in which products are provided from the CPC 604 to the hospital 610 via the cell preparation facility 606 or cell preparation vehicle 608 can also be widely applied to regenerative medicine products for allogeneic transplantation. Regenerative medicine products for allogeneic transplantation are manufactured at the CPC using cells derived from cells other than those of the patient to be transplanted, and are stored in a storage facility as needed.

[0118] In the above explanation, the cell preparation facility 606 and the cell preparation vehicle 608 are described as facilities supporting multiple hospitals 610. Alternatively, the cell preparation facility 606 or the cell preparation vehicle 608 can be dedicated to each hospital 610. In this case, the cell preparation facility 606 can be located closer to the hospital 610 than in the above example. Specifically, the proximity can be a location where the travel time from the cell preparation facility 606 to the treatment location is within 10 minutes, 5 minutes, 3 minutes, or 1 minute. Examples of a nearby location include the cell preparation facility 606 being located on the same premises, in the same building, or on the same floor level within the same building, connected to the treatment location. When the cell preparation facility 606 or the cell preparation vehicle 608 is provided for each hospital 610, the number of clean room systems 606a and 608a installed will increase, which is why adopting an exhaust structure that can be installed and maintained at low cost is advantageous. [Explanation of symbols]

[0119] 10 clean room system, 20 clean room, 22 interior, 24 buffer room, 26 outer door, 28 inner door, 30 air supply unit, 32 HEPA filter, 34 air supply fan, 40 safety cabinet, 42 workspace, 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 workspace 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 hazard control cabinet comprising: a work space; a work space air supply path for supplying air from inside the clean room to the work space; a work space exhaust path for exhausting air from the work space to the outside of the clean room; an exhaust fan provided in the work space exhaust path for driving the exhaust; and a filter provided in the work space exhaust path for purifying the exhaust air; Equipped with A clean room system, characterized in that the exhaust fan 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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