Clean room system and clean room system mounted vehicle

Abstract

To realize a clean room system capable of reducing the setting cost or maintenance cost. A clean room system (10) has: a clean room (20) having air tightness; a supply air unit (30) that supplies air from the outside (90) to the inside (22) of the clean room; and a safety cabinet (40). The safety cabinet (40) has: a work space (42); a work space supply air path that supplies air from the inside (22) to the work space (42); a work space exhaust path that exhausts air from the work space (42) to the outside (90); an exhaust fan (60) provided to the work space exhaust path that drives the exhaust air; and a filter (62) provided to the work space exhaust path that purifies the exhaust air. The exhaust fan (60) drives all the exhaust air from the inside (22) to the outside (90) and maintains the inside (22) as a negative pressure.

Description

Technical Field

[0001] This invention relates to cleanroom systems and vehicles equipped with cleanroom systems. Background Technology

[0002] In a negative pressure cleanroom where the internal pressure is maintained lower than the external pressure, air flows from the outside to the inside of the cleanroom through the connection between the cleanroom and the outside. Therefore, in a negative pressure cleanroom, it is possible to reduce or prevent the leakage of air containing airborne particles such as infectious substances from the inside of the cleanroom to the outside.

[0003] Sometimes, cleanrooms are equipped with devices such as safety cabinets that provide working spaces for handling infectious materials and other objects. In most cases, the safety cabinet controls the air supply and exhaust within the working space on its own.

[0004] Non-patent document 1 is the Japanese Industrial Standard (JIS) concerning safety cabinets and similar devices. The devices are referred to as biological hazard response cabinets and are classified into Category I, Category II, and Category III based on their basic structure. Category I and Category II are open types with openings (front surface openings) on the front wall of the work area, while Category III is a closed type without openings.

[0005] Category I devices are typically referred to as ventilation chambers, which supply unfiltered air drawn in from a front surface opening to the work area, and then filter and exhaust the exhaust from the work area. Category II devices are typically referred to as safety cabinets. In the type with a recirculation path, air drawn in from the front surface opening is drawn into the recirculation path. The recirculated air repeatedly undergoes the following process: being filtered and supplied to the work area, and then exhausted from the work area. During this process, a portion of the air is exhausted to the outside after being filtered. In the type without a recirculation path, additional air drawn in from the outside is filtered and supplied to the work area, and the air supplied to the work area and the air supplied from the front surface opening are filtered together and exhausted to the outside. Category III is a category of devices typically referred to as isolators, which filter and supply air drawn in from the outside to the work area, and filter and exhaust the exhaust from the work area. This standard is given a biological name, but is not limited to applications in the biological field; it is also developed considering applications for handling volatile substances and other substances.

[0006] Patent Document 1 describes a negative pressure cleanroom formed by combining different zones. This cleanroom is used for biological applications and includes a biosafety cabinet inside. The cleanroom is constructed by integrating the air supply and exhaust systems of both the cleanroom itself and the biosafety cabinet. Specifically, air is supplied to the cleanroom via an air supply fan, and exhaust is performed from the cleanroom to the outside via an exhaust fan. Additionally, a separate local exhaust fan is provided to exhaust air from the biosafety cabinet to the outside of the cleanroom. These fans are controlled by a control unit to maintain a negative pressure inside the cleanroom.

[0007] Patent Document 2 described below relates to a slightly positive pressure type open cleanroom (referred to as a clean booth in this document) with a biosafety cabinet and the like, based on an airflow barrier method. An always-open entrance / exit without a door is provided on the wall of the cleanroom, and an air supply fan is installed on the ceiling. Air is supplied to the interior of the cleanroom by the air supply fan. Within the biosafety cabinet, a fan installed in the cabinet supplies air to the interior of the cleanroom; after the air flows through the work space, it is exhausted from the biosafety cabinet into the interior of the cleanroom. Then, the air inside the cleanroom flows in one direction toward the entrance / exit and is exhausted to the outside of the cleanroom.

[0008] Patent Document 3 describes a technique for transplanting cells collected from a patient into the patient after processing. Cells collected from an academic institution are processed in a cell culture and processing facility (referred to as CPF in the document) and returned to the academic institution for transplantation into the patient within the institution. The cells to be transplanted are considered pharmaceuticals, and the manufacturer is required to comply with U.S. regulations and implement a series of process controls according to CGMP standards (paragraphs 0012 to 0018, etc.). Therefore, this document proposes setting up a CGMP-compliant facility near the location where the patient receives treatment and implementing necessary management measures (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 in which it is implemented. In Japan, in Non-Patent Document 2, "products such as regenerative medicine" are defined as follows: "These refer to the following items as determined by government ordinance (excluding quasi-pharmaceuticals and cosmetics)."

[0010] I. Articles intended for use in the following medical or veterinary medicine purposes, including articles that involve the culture and other processing of human or animal cells.

[0011] (a) The reconstruction, repair or formation of the structure or function of a human or animal body

[0012] (ii) Treatment or prevention of diseases in humans or animals

[0013] 2. "Articles intended for use in the treatment of diseases in humans or animals that contain genes introduced into human or animal cells and expressed in their bodies." Furthermore, Non-Patent Document 3 stipulates safety assurances for regenerative medicine, including regenerative medical products.

[0014] Existing technical documents

[0015] Patent documents

[0016] Patent Document 1: Japanese Patent Application Publication No. 2005-326093

[0017] Patent Document 2: Japanese Patent Application Publication No. 2019-100594

[0018] Patent Document 3: U.S. Patent Publication No. 2003-0175242A1

[0019] Non-patent literature

[0020] Non-Patent Document 1: JIS K3800 Biohazard Response Category II Cabinet, revised July 20, 2021

[0021] Non-patent literature 2: Japanese Laws relating to the assurance of quality, efficacy, and safety of pharmaceuticals, medical devices, etc.

[0022] Non-patent literature 3: Japanese "Law Related to Ensuring the Safety of Regenerative Medicine, etc." Summary of the Invention

[0023] The problem that the invention aims to solve

[0024] There is a need for a simple negative pressure cleanroom. However, in the cleanroom of Patent Document 1, an exhaust fan for exhausting air from the inside of the cleanroom to the outside and a local exhaust fan for exhausting air from the inside of the biosafety cabinet to the outside of the cleanroom are provided. The main exhaust system of the cleanroom and the local exhaust system via the biosafety cabinet are controlled in an integrated manner, resulting in a redundant exhaust structure. Patent Document 2 describes a simple exhaust structure, but it is merely a structure based on a positive pressure cleanroom.

[0025] The purpose of this invention is to realize a negative pressure cleanroom system that reduces manufacturing or maintenance costs.

[0026] Furthermore, in order to successfully conduct regenerative medicine, there is a need to set up cleanrooms for processing cells in or near hospitals where patients receive treatment. However, Patent Document 3 mentioned above does not consider the costs of setting up or maintaining such facilities.

[0027] Another object of the present invention is to facilitate the setup or maintenance of clean rooms in or near hospitals where regenerative medicine is performed.

[0028] Methods for solving problems

[0029] The cleanroom system of the present invention comprises: a cleanroom having airtightness; an indoor air supply path that supplies air from the outside of the cleanroom to the inside; and a hazard response cabinet disposed inside the cleanroom, having a work space, a work space air supply path, a circulation path, a work space exhaust path, an exhaust fan, and a filter. The work space air supply path supplies air from the inside of the cleanroom to the work space. The circulation path draws in air from the work space and supplies it back to the work space. The work space exhaust path is a flow path having a shared portion with the circulation path and separating from the circulation path midway to reach the outside. The air supply path from the work space to the cleanroom... External exhaust is provided by an exhaust fan located in the shared portion of the circulation path and the exhaust path of the work space, or in a separate portion thereof. This fan drives the circulation in the circulation path and the exhaust in the work space exhaust path. A filter is located in the work space exhaust path to purify the exhaust. No other fans are installed between the location of the exhaust fan and the work space in the circulation path. The exhaust fan, which drives the circulation in the circulation path and the exhaust in the work space exhaust path, drives all exhaust from the inside of the cleanroom to the outside, and maintains the interior of the cleanroom at negative pressure. This cleanroom system may also have a circulation path that draws in air from the work space and resupplys it. Alternatively, the exhaust fan may also drive the circulation in the circulation path and the exhaust in the exhaust path.

[0030] A workspace is a space where workers or equipment perform operations on a work object. A hazard response cabinet is a device that provides controlled air supply and exhaust to a workspace and performs hazard response based on particles generated within that workspace. Hazard response refers to the response measures taken to reduce or eliminate hazards to workers or the surrounding environment. Hazard response cabinets include, but are not limited to, biohazard response cabinets having the basic structures of categories I, II, and III as described in Non-Patent Document 1. Hazard response cabinets also include hazard response cabinets that, while not meeting the numerical, structural, or material requirements specified in Non-Patent Document 1, are capable as a whole of implementing the level of hazard response required by the user.

[0031] Maintaining a negative pressure inside a cleanroom means satisfying one or both of the following conditions: the internal air pressure is controlled to be lower than the external air pressure on a time-averaged basis, or the airflow is from the outside to the inside of the cleanroom on a time-averaged basis. Air pressure fluctuates both temporally and spatially due to fan operation, airflow turbulence, etc. Therefore, by using time averaging, the state after smoothing out these fluctuations can be evaluated. The time averaging period depends on the response speed of the air pressure sensor, for example, approximately 60 seconds, 30 seconds, or 10 seconds. Furthermore, the direction of airflow can be confirmed through smoke testing. The internal and external air pressure difference can be set in various ways, with specific values ​​including 30 Pa, 20 Pa, 10 Pa, 5 Pa, 3 Pa, and 1 Pa. The air pressure difference can be set according to the level of reduction or prevention of airborne particulate leakage from the inside of the cleanroom to the outside. Additionally, the ease of opening and closing entrance doors, noise reduction, fan power consumption, or filter ventilation can also be considered when setting the air pressure difference. Even with a reduced pressure difference, a situation where the internal air pressure of the cleanroom is higher than the external air pressure (becoming positive pressure) for a short period of time is also considered. However, this short-term positive pressure is permissible as long as the resulting air leakage to the outside remains minimal and the cleanroom system can maintain a level capable of implementing hazard response.

[0032] Furthermore, in this cleanroom system, the hazard response cabinet includes an air supply path for the work space, an exhaust path for the work space, an exhaust fan, and a filter. However, these components are inseparable parts closely related to the cleanroom's own air supply and exhaust. In this respect, it can be said that the cleanroom and the hazard response cabinet are integrated. Therefore, some or all of these components may sometimes not be considered components of the hazard response cabinet, but are treated as components of the cleanroom or separately installed components in product catalogs, etc. Even in this case, if these components are elements required to realize the biohazard response cabinet, then they can be considered components of this hazard response cabinet, satisfying the constituent requirements of the present invention.

[0033] In one embodiment of the invention, a detour is provided, which connects to the exhaust path of the work space from the interior of the cleanroom without passing through the work space, and the exhaust fan also drives the air flowing in the detour. Alternatively, in other embodiments, a structure is employed that does not include a detour and only exhausts the air that has passed through the work space.

[0034] In one embodiment of the invention, the hazard response cabinet is a safety cabinet, and the work space is a space for working with biological objects. The safety cabinet includes, but is not limited to, safety cabinets that meet the category II requirements for biological hazard response cabinets in Non-Patent Document 1. Even if the numerical, structural, material, and other conditions specified in Non-Patent Document 1 are not met, as long as the cabinet as a whole can implement the level of biological hazard response required by the user, it is acceptable.

[0035] In one embodiment of the invention, the indoor air supply path is a natural air supply path that uses the negative pressure inside the cleanroom created by the exhaust fan as a driving force for air supply.

[0036] In one embodiment of the invention, the workspace is a space for processing regenerative medical products manufactured using cell culture processing facilities, and the cleanroom system is located near the treatment site where the regenerative medical products are used.

[0037] Regenerative medicine products include, but are not limited to, regenerative medicine products as defined in Non-Patent Document 2 above. Regenerative medicine products also include conventional cell products that involve culturing and other processing of animal cells. Furthermore, regenerative medicine products also include products classified as pharmaceuticals, quasi-pharmaceuticals, cosmetics, veterinary pharmaceuticals, etc., according to laws and regulations. Similarly, treatment locations, in addition to referring to treatment locations for patients, also include surgical locations for humans or animals that are not considered medical treatment under laws and regulations.

[0038] Regenerative medicine products include both those provided for a fee and those provided free of charge.

[0039] In one aspect of the invention, the treatment sites are distributed across two or more buildings, and the cleanroom system is located in a location near the treatment sites within at least two or more buildings.

[0040] The cleanroom system vehicle of the present invention comprises: the cleanroom system; and a vehicle carrying the cleanroom, wherein the work space is a space for operating regenerative medical products manufactured using cell culture processing facilities, and the vehicle is capable of moving to the vicinity of treatment sites where regenerative medical products are used.

[0041] Invention Effects

[0042] To achieve cleanroom systems that can reduce manufacturing or maintenance costs. Attached Figure Description

[0043] Figure 1 This is a perspective view of the cleanroom system according to the first embodiment.

[0044] Figure 2 This is a top view of the cleanroom system according to the first embodiment.

[0045] Figure 3 This is a side view of the cleanroom system according to the first embodiment.

[0046] Figure 4 This is a diagram illustrating the control method of the cleanroom system according to the first embodiment.

[0047] Figure 5 This is a side view of the cleanroom system according to the second embodiment.

[0048] Figure 6 This is a side view of the cleanroom system according to the third embodiment.

[0049] Figure 7 This is a side view of the cleanroom system according to the fourth embodiment.

[0050] Figure 8 This is a side view of the cleanroom system according to the fifth embodiment.

[0051] Figure 9 This is a diagram illustrating an example of the use of the cleanroom system according to the sixth embodiment. Detailed Implementation

[0052] Hereinafter, embodiments of the present invention will be described using the accompanying drawings. It should be noted that the embodiments are illustrative, and the present invention can be implemented in many more ways. Furthermore, it should be noted that the figures are simplified schematic diagrams illustrating the features of the embodiments, and the construction and scale are not necessarily accurate.

[0053] (1) First implementation method

[0054] Figure 1 , Figure 2 as well as Figure 3 These are a perspective view, a top view, and a side view of the cleanroom system 10 according to the first embodiment. Figure 4 This is a block diagram illustrating the control method of the cleanroom system 10 according to embodiment 1.

[0055] First, refer to Figures 1-3 The overall structure of the cleanroom system 10 will be described. The cleanroom system 10 is a system consisting of a cleanroom 20 whose cleanliness is managed and its associated equipment.

[0056] Cleanroom 20, comprising a floor, walls, and ceiling, is a closed structure that maintains an airtight interior space 22. Airtightness refers to a state that reduces or blocks the flow of air between the interior 22 and the exterior 90; airtightness refers to the characteristic of maintaining a space airtight. By possessing airtightness, the cleanliness of the interior 22 of cleanroom 20 can be managed. Cleanliness can be quantified, for example, by the amount of airborne particles. The floor, walls, and ceiling of cleanroom 20 are formed, for example, by tightly assembling panel components manufactured in a quality-controlled factory. Alternatively, some or all of the walls, floor, and ceiling of cleanroom 20 can be formed using the existing building structure. When cleanroom 20 is located within a building, the exterior 90 of cleanroom 20 can be a typical indoor space where cleanliness is not managed, or it can be another cleanroom where cleanliness is managed. Alternatively, cleanroom 20 can be located outdoors with its outer surface exposed to the outside. Furthermore, in... Figures 1-3 The cleanroom 20 is envisioned to be approximately 3m in each of the two horizontal directions and approximately 2m in height, as illustrated in the diagram. However, the size can be set in various ways. It can be set to be smaller than the above dimensions (for example, one or both of the two horizontal directions are approximately 2m), or it can be set to be larger than the above dimensions (for example, one or both of the two horizontal directions are approximately 4m, 6m, or 10m, or the height is approximately 3m or 4m).

[0057] The cleanroom system 10 of the first embodiment includes a cleanroom 20 and a buffer room 24 adjacent to the cleanroom 20. The buffer room 24 is located between the interior 22 and the exterior 90 of the cleanroom 20, serving as a buffer space for personnel entering and exiting or for handling work objects. The buffer room 24 has an outer door 26 and an inner door 28. The outer door 26 is used for entry and exit between the exterior 90 and the buffer room 24, and the inner door 28 is used for entry and exit between the buffer room 24 and the interior 22 of the cleanroom 20. The outer door 26 and the inner door 28 are controlled to prevent simultaneous opening, thus preventing direct air exchange between the interior 22 and the exterior 90 of the cleanroom 20. Furthermore, by providing the buffer room 24, the pressure change within the interior 22 of the cleanroom 20 during entry and exit can be reduced, thereby suppressing air turbulence.

[0058] The cleanroom 20 is equipped with an air supply unit 30 and a safety cabinet 40 as devices constituting the cleanroom system 10.

[0059] The air supply unit 30 is a device for controlling the air supply to the cleanroom 20. The air supply unit 30 is located in the flow path (referred to as the "indoor air supply path") that supplies air from the outside 90 to the inside 22 of the cleanroom 20. In the cleanroom system 10, the indoor air supply path is located on the ceiling of the cleanroom 20, relatively close to the buffer room 24. The air supply unit 30 is a device obtained by overlapping and modularizing a HEPA filter 32 and an air supply fan 34, and is installed in the indoor air supply path in a detachable manner. The HEPA filter 32 is a filter that removes airborne particles according to the HEPA (High Efficiency Particulate Air) standard. The HEPA filter 32 is detachably installed on the air supply fan 34. Therefore, by removing the air supply unit 30 and further removing the HEPA filter 32, the HEPA filter 32 can be easily cleaned and replaced.

[0060] The air supply fan 34 is a device equipped with a fan for supplying air. The term "fan" is a general term for any device that drives air, including propeller fans, Sirocco fans, centrifugal fans, and combination fans. The air supply fan 34 receives power from power lines (omitted in the diagram) and operates to drive air from the outside 90 of the cleanroom 20 to the inside 22. During this process, the air flows through the HEPA filter 32, thus removing particles contained in the outside air.

[0061] The safety cabinet 40 is an open-type hazard response cabinet with a front surface opening 44. The safety cabinet 40 is located near the wall of the interior 22 of the cleanroom 20, away from the buffer chamber 24. The safety cabinet 40 has a working space 42, a front surface opening 44, a HEPA filter 46, flow paths 50a to 50f, an exhaust fan 60, and a HEPA filter 62.

[0062] The workspace 42 is a space provided for performing work on the work object, and is sometimes referred to as a work hood, work chamber, etc. The workspace 42 is roughly rectangular in shape inside the safety cabinet 40. A HEPA filter 46 is installed on the upper surface of the workspace 42. The front surface of the workspace 42 (the side closest to the center of the room in the figure, the side where the operator is located) is made of a transparent glass plate, but its lower part forms an opening 44 without a resin plate. Holes communicating with the flow path 50a described later are provided on the bottom surface or around the workspace 42.

[0063] The front surface opening 44 is a part that communicates with the interior 22 of the clean room 20. In addition to allowing operators to pick up and put down their arms and work objects, it also serves as a flow path for supplying air from the interior 22 of the clean room 20 to the device.

[0064] HEPA filter 46 is disposed on the upper surface of workspace 42. HEPA filter 46 is a filter that purifies the air supplied to workspace 42, and the air flows from the upper surface of HEPA filter 46 to the lower surface. The air passing through HEPA filter 46 is purified in workspace 42 to a level that allows for operations known as aseptic operation.

[0065] like Figure 3 As shown, airflow paths 50a to 50f are provided around the workspace 42. Flow path 50a is located below the workspace 42 and communicates with a hole in the bottom surface of the workspace 42. Flow path 50a extends approximately horizontally along the front-rear direction of the safety cabinet 40. Flow path 50b is located behind the workspace 42 and extends vertically. The lower end of flow path 50b communicates with the rear end of flow path 50a. Flow path 50c is located on the extension line of flow path 50b and extends vertically. The lower end of flow path 50c communicates with the upper end of flow path 50b via an exhaust fan 60. Flow path 50d is located on the extension line of flow path 50c and extends approximately vertically. The lower end of flow path 50d is connected to the upper end of flow path 50c via HEPA filter 62, and the upper end of flow path 50d is connected to the outside 90 of clean room 20.

[0066] Airflow path 50e is located above the workspace 42 and extends approximately horizontally along the front-rear direction of the safety cabinet 40. The rear end of airflow path 50e is connected to the upper end of airflow path 50b via exhaust fan 60, and the front end of airflow path 50e is connected to the upper surface of HEPA filter 46. Airflow path 50f is the airflow path in the workspace 42, flowing downwards approximately uniformly within the workspace 42. The upper end of airflow path 50f is connected to the lower surface of HEPA filter 46, and the front end of airflow path 50e is connected via HEPA filter 46. The lower end of airflow path 50f is connected to airflow path 50a via a hole provided in the bottom surface of the workspace 42. In addition, the lower front part of airflow path 50f is connected to the interior 22 of cleanroom 20 (and the exterior of safety cabinet 40) via front surface opening 44. Part or all of airflow paths 50a to 50e can be formed, for example, using tubular pipes, or they can be formed using plate-like components. In this embodiment, flow paths 50a to 50e are installed on the frame constituting the safety cabinet 40, and the safety cabinet 40 covers the area around the flow paths 50a to 50e, so that the flow paths 50a to 50e are integrally formed with the safety cabinet 40.

[0067] An exhaust fan 60 is located in communication with flow paths 50b, 50c, and 50e. The exhaust fan 60 is a fan that drives air and is operated electrically. The exhaust fan 60 draws air from flow path 50b, distributes it to flow paths 50c and 50e, and then exhausts it. The distribution ratio can be constant, or it can be variablely controlled, for example, using an electrically operated valve.

[0068] HEPA filter 62 is installed in a removable manner between flow path 50c and flow path 50d. HEPA filter 62 is a filter that purifies exhaust gas from the interior 22 of cleanroom 20 to the exterior 90 to a level that can prevent or reduce hazards.

[0069] Typically, one HEPA filter 62 is provided in one location in the flow paths 50c and 50d, but it can also be provided in multiple locations, or multiple filters can be provided in one location.

[0070] Next, the operation of the cleanroom system 10 will be described. In the cleanroom system 10, personnel enter the interior 22 of the cleanroom 20 from the outside 90 via the buffer chamber 24. At this time, the personnel first open the outer door 26 to enter the buffer chamber 24 and then close the outer door 26. If the buffer chamber 24 is used as a changing room, the personnel put on the prescribed clothing, etc. Next, the personnel open the inner door 28 to enter the interior 22 of the cleanroom 20 and then close the inner door 28. The outer door 26 and the inner door 28 are interlocked and designed so that neither can be opened simultaneously.

[0071] Inside the cleanroom 20, 22, the operator is positioned in front of the safety cabinet 40, either standing or sitting. The operator then uses the front surface opening 44 to retrieve and place work objects and their arms within the work space 42, while simultaneously performing operations on the work objects.

[0072] In cleanroom 20, air 70a is supplied from the outside 90 to the inside 22 via an air supply unit 30 located in the indoor air supply circuit. An air supply fan 34 drives the air supply. The air 70a flows into the interior 22 of cleanroom 20 after being purified by a HEPA filter 32.

[0073] Inside the cleanroom 20 22, air 70b flows from the air supply unit 30 toward the front surface opening 44 of the biosafety cabinet 40. The air 70b is controlled to have relatively little turbulence and flows approximately in one direction. Then, air 70c is drawn into the interior of the biosafety cabinet 40 through the front surface opening 44 and enters the flow path 50a.

[0074] Inside the safety cabinet 40, air is driven by the exhaust fan 60 (and indirectly, the air supply fan 34 also drives the air). The function of the exhaust fan 60 can be categorized into three types: First, it supplies air from the interior 22 of the cleanroom 20 to the work space 42. Second, it circulates air within the safety cabinet 40. Third, it exhausts air to the outside 90. The details of each type are explained below.

[0075] In the first type of air supply, air originates from the interior 22, passes through the front surface opening 44, the lower front part of the working space 42 (also the lower front part of flow path 50f), flow paths 50a, 50b, and 50e, and is supplied to the working space 42. This flow path, which supplies air from the interior 22 of the cleanroom 20 to the working space 42, is referred to as the "working space air supply path." An exhaust fan 60 is located midway along the working space air supply path to drive the air supplied to the working space 42. Additionally, a HEPA filter 46 is installed in the working space air supply path to purify the air supplied to the working space 42.

[0076] In the second type of circulation, air flows in a circulation path consisting of flow path 50e, flow path 50f (working space 42), flow path 50a, and flow path 50b. An exhaust fan 60 is installed in this circulation path to drive the circulating air. In addition, a HEPA filter 46 installed in the circulation path purifies the passing air.

[0077] In this circulation path, the amount of air flowing into the flow path 50a from the holes provided on the bottom surface of the work space 42 is greater than the amount of air supplied to the work space 42 via 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 becomes air-deficient and negatively pressurized, so air is continuously drawn into the lower front part of the work space 42 through the front surface opening 44. The continuous suction flow formed at the front surface opening 44 reduces or prevents the leakage of particles that have dispersed into the interior of the work space 42 into the interior 22 of the cleanroom 20.

[0078] The third type of exhaust can be understood from two perspectives. One perspective is exhaust from the workspace 42 to the outside 90. In this perspective, air originates in the workspace 42, flows through flow paths 50a, 50b, 50c, and 50d, and reaches the outside 90 in the exhaust path (referred to as the "workspace exhaust path"). The other perspective is exhaust from the interior 22 of the cleanroom 20 to the outside 90. In this perspective, air originates in the interior 22, flows through the front surface opening 44, the lower front part of the workspace 42 (the lower front part of flow path 50f), flow paths 50a, 50b, 50c, and 50d, and reaches the outside 90 in the exhaust path (referred to as the "indoor exhaust path"). The flow path shared by the workspace exhaust path and the indoor exhaust path (referred to as the "shared exhaust path") is flow paths 50a, 50b, 50c, and 50d. The exhaust fan 60 and the HEPA filter 62 are both located in this shared exhaust path, driving the exhaust and purifying the exhaust, respectively.

[0079] The exhaust fan 60 exhausts air by discharging a portion of the air drawn from flow path 50b into flow path 50c. The air flowing in flow path 50b includes air flowing in the work space 42 and air flowing in from the front surface opening 44 but not yet passing through the work space 42. This latter air can be described as originating from the interior 22 of the cleanroom 20, passing through a "detour" formed by the front surface opening 44 and the lower front portion of the work space 42, merging with the work space exhaust path, thereby bypassing the work space 42 and directly exhausting to the outside 90. Furthermore, the detour path is combined with the common exhaust path to form an indoor exhaust path. The flow in the detour path is driven by the exhaust fan 60.

[0080] HEPA filter 62 purifies the air flowing in from flow path 50c, reducing particulate matter to below a reference value and directing it to flow path 50d. This reduces or prevents the leakage of particulate matter (e.g., infectious microorganisms, viruses, etc., including both the particulate matter itself and the aerosols it constitutes) that may be introduced into the workspace 42 to the outside 90.

[0081] The exhaust gas discharged to the outside 90 via the exhaust fan 60 is all the exhaust gas discharged from the inside 22 of the cleanroom 20 to the outside 90. Here, "all exhaust gas" refers to the total amount of exhaust gas discharged from the cleanroom 20 under control during the operation of the cleanroom system 10, excluding air leaking from tiny gaps in the walls of the cleanroom 20, turbulent backflow air from the air supply unit 30, and air leaking from the buffer chamber 24 when personnel enter and exit. In the cleanroom system 10, the exhaust fan 60 drives all the exhaust gas, thus simplifying the exhaust system structure and reducing manufacturing and maintenance costs. Furthermore, the cleanroom system 10 reduces the number or locations of HEPA filters 62 installed in the common exhaust path, potentially further reducing manufacturing and maintenance costs.

[0082] In the cleanroom system 10, the interior 22 of the cleanroom 20 is maintained at a negative pressure. In this negative pressure cleanroom 20, where the interior 22 is maintained at a negative pressure, air leakage from the walls of the cleanroom 20, air leakage from the air supply unit 30, or air leakage from the buffer chamber 24 during entry and exit can be reduced or prevented. Therefore, leakage of particles generated during operations in the workspace 42 to the outside 90 can be prevented or reduced.

[0083] The exhaust fan 60 operates using power capable of maintaining a negative pressure in the cleanroom 20. The power required for the operation of the exhaust fan 60 also depends on the power of the supply fan 34. Therefore, in the cleanroom system 10, the exhaust fan 60 and the supply fan 34 are controlled by monitoring various conditions.

[0084] Here, refer to Figure 4 An example of controlling the exhaust fan 60 and the air supply fan 34 in the cleanroom system 10 is described.

[0085] UI 100 is a user interface with an input section and a display section formed by a touch panel display, etc. UI 100 can be installed, for example, near the entrance of cleanroom 20, or on a terminal that can be carried by the operator. The display section of UI 100 displays the operating status of cleanroom system 10, and the input section accepts various user inputs. Examples of inputs include start and stop indications for cleanroom system 10, as well as settings for switching operating power during and off-peak hours of workspace 42, and cleanliness settings.

[0086] Outdoor pressure sensor 102 and indoor pressure sensor 104 are pressure sensors respectively installed on the exterior 90 and interior 22 of cleanroom 20. Indoor temperature sensor 106 is a temperature sensor installed on the interior 22 of cleanroom 20. Indoor particle sensor 107 and workspace particle sensor 108 are sensors respectively installed on the interior 22 of cleanroom 20 and workspace 42, and measure suspended particles in the air of the spaces where they are located. These various sensors perform measurements in real time.

[0087] The control device 110 is a device that controls computer hardware, including a central processing unit and memory, through embedded software to perform its operations. The control device 110 includes a recording unit 112, a processing unit 114, and an operation mode table 116, all configured under the control of the embedded software. The recording unit 112 records the operation status of the cleanroom system 10. The recorded data includes sensing data sent to the control device 110 from various sensors and operation data sent to the control device 110 from the air supply fan 34 and the exhaust fan 60. Additionally, the recording unit 112 also records instruction data, setting data, and control status data from the UI 100. The processing unit 114 switches the operation modes of the air supply fan 34 and the exhaust fan 60 according to the instruction data sent from the UI 100. Then, based on the operation mode table 116, the processing unit 114 instructs the air supply fan 34 and the exhaust fan 60 to operate in the corresponding mode. In addition, the following feedback control is performed in the arithmetic unit 114: the power of the air supply fan 34 and the exhaust fan 60 is fine-tuned by monitoring the sensing data sent from various sensors to the control device 110.

[0088] Operating mode table 116 sets the power data for the air supply fan 34 and exhaust fan 60 under various operating modes. An operating mode is the way the air supply fan 34 and exhaust fan 60 operate. Operating modes include stop mode, normal operating mode, high power mode, and low power mode. Additionally, a power-saving mode can be set within the operating modes to allow the air supply fan 34 and exhaust fan 60 to operate efficiently without the use of the safety cabinet 40. Operating mode table 116 sets the power values ​​for the air supply fan 34 and exhaust fan 60 to operate under each operating mode.

[0089] The air supply fan 34 and the exhaust fan 60 operate under the control of the control device 110, with their power adjusted accordingly. Furthermore, the actual power data of the air supply fan 34 and the exhaust fan 60 is sent to the control device 110 and monitored by the arithmetic unit 114.

[0090] Furthermore, in the cleanroom system 10, by controlling the relatively increased power of the air supply fan 34, the cleanroom 20 can be maintained at positive pressure (meaning that the pressure inside 22 is higher than the pressure outside 90 on average over time). A positive-pressure cleanroom 20 is suitable for reducing or preventing particles from flowing into the inside 22 from the outside 90. When there is a need for operation under positive pressure, the control device 110 can also be configured to switch the cleanroom system 10 between negative and positive pressure based on input from UI 100.

[0091] In the above description, the air supply fan 34 and the exhaust fan 60 are controlled while monitoring various data. However, as long as they operate in a way that ensures the required negative pressure, the air supply fan 34 and the exhaust fan 60 can also be controlled without monitoring.

[0092] In addition, the above description assumes that the air supply and exhaust are from the ceiling. However, it is also possible to supply and exhaust one or both of the air from parts other than the ceiling (walls or floor).

[0093] In the above description, HEPA filters 32, 46, and 62 are used in the cleanroom system 10 as filters for purifying the air. HEPA filters are high-precision particulate filters whose specific performance is specified by JIS, ISO, EN standards, etc. Cleanroom system 10 is equipped with HEPA filters 32, 46, and 62 according to appropriate standards. By using HEPA filters, in most cases when using cleanroom system 10, the required cleanliness can be expected to be ensured. However, in cleanroom system 10, some or all of the HEPA filters 32, 46, and 62 can be replaced with other filters depending on the required cleanliness. For example, higher-performance filters (such as ULPA) or lower-performance filters can be used instead of HEPA filters. In addition, HEPA particulate capture can be achieved not only by the fineness of the filter but also by electrostatic methods. In electrostatic methods, continuous operation is usually required to continuously generate static electricity in order to continuously adsorb particulates. In the type that utilizes static electricity, in order to achieve the above-mentioned power-saving mode, for example, the supply and exhaust volume can be controlled at a level that can prevent or stop the falling of particles at a specified level.

[0094] In the above description, a buffer chamber 24 is provided in the cleanroom system 10. However, the cleanroom system 10 can also be compactly formed without providing a buffer chamber 24. In addition, in other ways, the buffer chamber 24 can be used exclusively for entry, while a separate buffer chamber can be provided exclusively for exit.

[0095] The above description illustrates a safety cabinet 40 as an open-type hazard response cabinet. However, the above embodiment can be easily applied to open-type hazard response cabinets other than the safety cabinet 40, such as ventilation rooms.

[0096] In the ventilation chamber, air drawn in through the front surface opening (equivalent to the work space air supply path) is directly supplied to the work space. Additionally, a work space exhaust path is provided to exhaust air from the work space to the outside of the cleanroom; an exhaust fan and filter are installed in the work space exhaust path. The flow path formed by the front surface opening, the work space, and the work space exhaust path is equivalent to the indoor exhaust path, and the work space exhaust path is consistent with the common exhaust path. Furthermore, by not providing an exhaust path connecting to the outside of the cleanroom, a negative pressure cleanroom system can be formed where the exhaust fan drives all exhaust air, and the filter purifies all exhaust air.

[0097] (2) Second implementation method

[0098] Reference Figure 5 The cleanroom system 210 of the second embodiment will be described. Figure 5 This is a side view of the second embodiment. Figure 5 In the middle, to and Figure 3 (Side view of the first embodiment) The same or substantially the same parts are labeled with the same reference numerals, and the description is simplified or omitted.

[0099] In the cleanroom system 210, the cleanroom 220 includes an air supply unit 30 and a safety cabinet 240. The safety cabinet 240 includes a workspace 42, a front surface opening 44, a HEPA filter 46, flow paths 250a to 250f, an exhaust unit 261, and a workspace air supply fan 264. Flow paths 250a to 250f are formed in approximately the same shape and at approximately the same location as flow paths 50a to 50f in the first embodiment.

[0100] The flow path 250b is connected at its upper end to the lower end of the flow path 250c and the rear end of the flow path 250e. Furthermore, the exhaust unit 261 is detachably installed near the connection point of the flow paths 250c and 250d. The exhaust unit 261 is formed by overlapping and unitizing an exhaust fan 260 and a HEPA filter 262 located directly above the exhaust fan 260. The HEPA filter 262 is a filter for purifying the exhaust gas and is detachably installed in the exhaust unit 261. Therefore, when cleaning or replacing the HEPA filter 262, the exhaust unit 261 can be removed first, and then the HEPA filter 262 can be removed from the exhaust unit 261 for cleaning and replacement. A workspace air supply fan 264 is provided near the front end of the flow path 250e. The workspace air supply fan 264 is a fan that drives the air supply to the workspace 42.

[0101] In the second embodiment, the air supply path to the workspace is a path that starts from the interior 22, passes through the front surface opening 44, the lower front part of the workspace 42 (the lower front part of flow path 250f), flow path 250a, flow path 250b, and flow path 250e, and reaches the workspace 42. The exhaust path to the workspace is a path that starts from the workspace 42, passes through flow paths 250a, 250b, 250c, and 250d, and reaches the exterior 90. The indoor exhaust path is a path that starts from the interior 22, passes through the front surface opening 44, the lower front part of the workspace 42, and flow paths 250a, 250b, 250c, and 250d, and reaches the exterior 90. Furthermore, the common exhaust path is a path composed of flow paths 250a, 250b, 250c, and 250d. Additionally, the circulation path is composed of the workspace 42 (flow path 250f), flow paths 250a, 250b, and 250e.

[0102] The exhaust fan 260 is driven to discharge air from the interior 22 to the outside 90 through the front surface opening 44, the lower front part of the work space, and flow paths 250a, 250b, 250c, and 250d. However, the exhaust fan 260 does not drive the flow in flow path 250e or the work space 42. This can be understood by examining the state where only the exhaust fan 260 operates, while the work space air supply fan 264 is stopped. Furthermore, the work space air supply fan 264 is a circulation drive fan that only drives the flow in the circulation path formed by the work space 42, flow paths 250a, 250b, and 250e. This can be understood by examining the state where the exhaust fan 260 is stopped, and only the work space air supply fan 264 operates. Of course, when the exhaust fan 260 and the work space air supply fan 264 operate simultaneously, in addition to linear superposition, a nonlinear effect also occurs. However, this nonlinear effect is limited. If the effect of the workspace air supply fan 264 on the exhaust is disregarded, it can be considered that the exhaust fan 260 installed in the common exhaust path drives all the exhaust. Furthermore, it can be considered that the HEPA filter 262 installed in the common exhaust path purifies all the exhaust. In the second embodiment, compared to the first embodiment, there is redundancy in having the workspace air supply fan 264, but the exhaust structure is simply implemented.

[0103] The above description illustrates an example where only one safety cabinet 240 is installed inside the cleanroom 220. However, it is also possible to install multiple hazard response cabinets of the same or different types in the cleanroom 220. In the case of multiple hazard response cabinets, it is necessary to establish workspace exhaust paths that exhaust air from each workspace to the outside 90 of the cleanroom 220. Each workspace exhaust path can be separate and connected to the outside 90, and each can be equipped with an exhaust fan and a filter. Alternatively, the exhaust paths of each workspace can be combined, with the combined path connected to the outside 90. In the case of combined paths, an exhaust fan and filter can be installed only in the combined path. When only an exhaust fan is installed in the combined path, a circulation drive fan can be installed inside each hazard response cabinet to circulate the air within each cabinet.

[0104] (3) Third implementation method

[0105] Reference Figure 6 The cleanroom system 310 of the third embodiment will be described. Figure 6 This is a side view of the third embodiment. Figure 6 In the middle, to and Figure 3 (Side view of the first embodiment) The same or substantially the same parts are labeled with the same reference numerals, and the description is simplified or omitted.

[0106] In the cleanroom system 310, the cleanroom 320 includes an air supply unit 30 and an isolator 340. The isolator 340 is a closed hazard response cabinet with a work space 342 without openings. A glove box 344 is provided on the front surface of the isolator 340 instead of an opening on the front surface. In the glove box 344, a soft glove is protruding and positioned on one side of the work space 342. The glove is airtight, allowing the operator to access the work objects located inside the work space 342 from the outside of the work space 342.

[0107] 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 from the interior 22 of the cleanroom 320. Flow path 350a is located above the work space 342 and extends approximately horizontally in the front-to-back direction. The front end of flow path 350a opens into the interior 22 of the cleanroom 320. Flow path 350b is a flow path for air that flows approximately uniformly downward in the work space 342. The upper end of flow path 350b is connected to 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 located below the work space 342 and extends approximately horizontally in the front-to-back direction of the isolator 340. Flow path 350c is connected to flow path 350b via a hole provided in the bottom surface of the work space 342. Flow path 350d is located behind the workspace 342, extending vertically, with its upper end reaching a position higher than the upper surface of the workspace 342. The lower end of flow path 350d connects to the rear end of flow path 350c. Flow path 350e is an extension of flow path 350d, extending vertically. The lower end of flow path 350e connects to the upper end of flow path 350d via exhaust fan 360. Flow path 350f is an extension of flow path 350e, extending vertically. The lower end of flow path 350f connects to the upper end of flow path 350e via HEPA filter 362. The upper end of flow path 350f opens to the outside 90 degrees of the cleanroom 320.

[0108] Exhaust fan 360 is a fan that drives the exhaust. Exhaust fan 360 is located between flow path 350d and flow path 350e. HEPA filter 362 is a filter that purifies the exhaust. HEPA filter 362 is located between flow path 350e and flow path 350f.

[0109] In cleanroom system 310, air 70a is supplied to the interior 22 of cleanroom 320 via air supply unit 30. Inside 22, air 370b flows approximately in one direction and reaches the front end of flow path 350a. After being purified by HEPA filter 46, the air flowing in flow path 350a flows in flow path 350b inside workspace 342 and enters flow path 350c through holes provided in the bottom surface of workspace 342. After moving to flow path 350d, the air entering flow path 350c is drawn by exhaust fan 360 and discharged into flow path 350e. Then, the air is purified by HEPA filter 362 and discharged to the outside 90 after passing through flow path 350f.

[0110] Within the working space 342 of the isolator 340, only air purified by the HEPA filter 46 flows in, thus achieving a high level of cleanliness. Furthermore, exhaust gas from the working space 342 is purified by the HEPA filter 362, preventing particles generated within the working space 342 from leaking to the outside 90. Of course, within the isolator 340, particles from the working space 342 also do not leak into the interior 22 of the cleanroom 320.

[0111] In the cleanroom system 310, the air supply path for the workspace is flow path 350a, and the exhaust path for the workspace is flow paths 350c, 350d, 350e, and 350f. Additionally, the indoor exhaust path is flow paths 350a, 350b, 350c, 350d, 350e, and 350f, and the shared exhaust path is consistent with the exhaust path for the workspace.

[0112] An exhaust fan 360 is installed in the common exhaust path. It drives the air supply to the work space and the exhaust from the work space and the indoor exhaust path. In the cleanroom system 310, no exhaust is discharged to the outside 90 except from the exhaust from the flow path 350f. Therefore, the exhaust fan 360 drives all the exhaust from the cleanroom system 310. Furthermore, a HEPA filter 362 is installed in the common exhaust path to purify all the exhaust. A simple exhaust configuration is also achieved in this third embodiment.

[0113] (4) Fourth implementation method

[0114] Reference Figure 7 The cleanroom system 410 of the fourth embodiment will be described. Figure 7 This is a side view of the fourth embodiment. Figure 7 In the middle, to and Figure 6 (Side view of the third embodiment) The same or substantially the same parts are labeled with the same reference numerals, and the description is simplified or omitted.

[0115] In the cleanroom system 410, the cleanroom 420 includes an air supply unit 30 and an isolator 340. The isolator 440 is configured to... Figure 6 The isolator in the third embodiment shown is substantially the same.

[0116] The fourth embodiment differs from the third embodiment in the presence of flow path 450g. Flow path 450g is located above the work space 342 and extends approximately horizontally along the front-rear direction of isolator 440. The front end of flow path 450g opens into the interior 22 of cleanroom 420. The rear end of flow path 450g communicates with the upper end of flow path 450d1 and the lower end of flow path 450d2.

[0117] In isolator 440, air flows in the same manner as in isolator 340 of the third embodiment. That is, air from the interior 22 of cleanroom 420 is supplied to workspace 342 via flow path 350a. Then, air from workspace 342 is exhausted to the outside 90 via flow paths 350c, 450d1, 450d2, 350e, and 350f. This exhaust is driven by exhaust fan 360 and purified by HEPA filter 362.

[0118] Additionally, a flow originating from the interior 22 of the cleanroom 420, bypassing the workspace 342, passes through flow paths 450g, 450d2, 350e, and 350f as exhaust paths and is discharged to the outside 90. This is because flow path 450g bypasses the workspace 342 and merges with the connection point of flow paths 450d1 and 450d2 to form a loop. The exhaust via flow path 450g is also driven by the exhaust fan 360 and purified by the HEPA filter 362. The exhaust volume through flow path 450g can be adjusted, for example, by adjusting the cross-sectional area of ​​flow path 450g, or by installing a movable valve in flow path 450g for variable control.

[0119] In the fourth embodiment, the air supply path for the work space is flow path 350a, and the exhaust path for the work space is flow paths 350c, 450d1, 450d2, 350e, and 350f. There are two types of indoor 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 indoor exhaust paths and work space exhaust paths is flow path 450d2, 350e, and 350f. No other exhaust paths are provided. The exhaust fan 360 and HEPA filter 362 are located in the common exhaust path and respectively drive and purify all exhaust gas.

[0120] (5) Fifth implementation method

[0121] Reference Figure 8 The cleanroom system 510 of the fifth embodiment will be described. Figure 8 This is a side view of the fifth embodiment. Figure 8 In the middle, to and Figure 3 (Side view of the first embodiment) The same or substantially the same parts are labeled with the same reference numerals, and the description is simplified or omitted.

[0122] In the cleanroom system 510 of the fifth embodiment, unlike the cleanroom system 10 of the first embodiment, no air supply fan is provided in the air supply unit 530. Only a HEPA filter 532 is provided in the air supply unit 530.

[0123] In the cleanroom system 510, the interior 22 of the cleanroom 520 has a low air volume due to the exhaust from the exhaust fan 60, thus creating a negative pressure. The exhaust fan 60 increases its power to operate, thereby increasing the degree of negative pressure inside the 22. Therefore, the required amount of air 570 overcomes the air resistance of the HEPA filter 532 installed in the indoor air supply path and flows from the outside 90 into the interior 22. That is, the air supply in the cleanroom system 510 is driven by the pressure difference between the interior 22 and the outside 90 of the cleanroom 520. If limited to this air supply section, no power is used, and it can be called natural air supply.

[0124] In the fifth embodiment, the exhaust structure is configured simply as in the first embodiment, and the indoor air supply path is used as a natural air supply path. Therefore, in the cleanroom system 510, there is a possibility of reducing manufacturing costs or maintenance costs.

[0125] (6) 6th implementation method

[0126] As mentioned above, negative pressure cleanroom systems have biohazard mitigation capabilities, preventing or reducing the leakage of particulate matter generated in the work space. Therefore, negative pressure cleanroom systems are mostly used in situations where substances that may have negative impacts on human health or the environment are the objects of the work. The handling of these objects includes collection, testing, inspection, processing, and manufacturing.

[0127] Radioactive materials are examples of work objects requiring biohazard response. Radioactive pharmaceuticals are pharmaceuticals that use radioactive materials. Additionally, toxic or highly physiologically active chemical substances are also work objects requiring hazard response. Anticancer agents are an example of highly physiologically active chemical substances. Furthermore, biological objects are work objects requiring biohazard response. Here, biological objects refer to objects derived from living organisms (including viruses), either in whole or in part, or that have undergone processing. Examples of biological objects include human, animal, or microbial tissues, cells, or nucleic acids, or these processed products. Blood samples are also examples of biological objects. Hazard response is particularly necessary for samples involving highly contagious infectious diseases that have a significant impact on public health. Antibody pharmaceuticals, nucleic acid pharmaceuticals, and regenerative medicine products are also examples of biological objects. Biological objects require biohazard response because they may contain infectious or pathogenic substances.

[0128] In the sixth embodiment, as an example requiring biohazard response, the utilization of a cleanroom system in the field of regenerative medicine related to autologous cell transplantation will be described.

[0129] Figure 9 This is a diagram illustrating the network 600 of the sixth embodiment. Figure 9The network 600 shown is obtained by connecting the delivery associated facilities of the regenerative medicine product 602. The network 600 includes CPC 604, cell preparation facility 606, cell preparation vehicle 608, and hospitals 610a, 610b, 610c, and 610d (sometimes referred to in part or in whole as hospital 610).

[0130] CPC 604 is sometimes referred to as a Cell Processing Center (Cell Culture and Processing Facility) or CPF (Cell Processing Facility). CPC 604 has cleanrooms where cells collected from patients are processed to manufacture regenerative medical products 602. The cleanroom systems illustrated in embodiments 1 to 5 can be incorporated into CPC 604. CPC 604 is a relatively large facility, and there are cases where it has multiple large cleanrooms with multiple biohazard response cabinets within each cleanroom. Therefore, it is also considered that, in addition to the biohazard response cabinets, the cleanrooms in CPC 604 should have their own exhaust systems.

[0131] Cell preparation facility 606 is a facility located between CPC 604 and hospital 610. In cell preparation facility 606, cells collected from patients or regenerative medical products 602 manufactured are prepared and transported. Cell preparation facility 606 is located inside a building and includes a cleanroom system 606a as illustrated in embodiments 1 to 5. Cell preparation is performed using the workspace of a hazard response cabinet provided in the cleanroom system 606a. Furthermore, cell preparation generally refers to processes that alter the state of cells or processes that test or examine the state of cells.

[0132] The cell preparation vehicle 608, located between CPC 604 and hospital 610, is a vehicle used for the preparation and delivery of cells collected from patients or manufactured regenerative medical products. The cell preparation vehicle 608 is formed by mounting a self-driving vehicle equipped with an electric motor, internal combustion engine, etc., on the cleanroom system 608a illustrated in the first to fifth embodiments.

[0133] Hospital 610 is a facility where doctors, dentists, veterinarians, and other professionals engaged in regenerative medicine diagnose and treat patients. Hospitals 610a to 610d are envisioned to be established by different organizations and located in buildings in different locations. Regenerative medicine related to autologous transplantation is conducted in Hospital 610. Doctors and dentists are responsible for collecting tissues or cells from patients and transplanting regenerative medical products 602 to patients.

[0134] In the sixth embodiment, it is envisioned that the number of hospitals 610 is the largest, the number of cell preparation facilities 606 or cell preparation vehicles 608 is the second largest, and the number of CPCs 604 is the smallest. Furthermore, the CPCs 604 serve multiple hospitals 610 via multiple cell preparation facilities 606 or cell preparation vehicles 608. Additionally, each cell preparation facility 606 or cell preparation vehicle 608 serves multiple hospitals 610. Of course, a single hospital 610 may utilize multiple cell preparation facilities 606 or cell preparation vehicles 608, or a single cell preparation facility 606 or cell preparation vehicle 608 may utilize multiple CPCs 604.

[0135] In the case of regenerative medicine related to autologous transplantation, cells are first collected from one or more patients at hospital 610. During collection, staff from cell preparation facility 606 or cell preparation vehicle 608 assist with the collection at hospital 610. Examples of assistance include inputting patient and cell information into a computer, storing the collected cells in containers with controlled temperature and cleanliness, and adjusting the transplantation date and time.

[0136] The collected cells are taken back to cell preparation facility 606 or cell preparation cart 608. Then, the required cell preparation is performed using cleanroom systems 606a and 608a. Examples of cell preparation include one or more processes selected from cell washing, reagent addition, refrigeration, freezing, container storage, and examination of infectious specimens containing sterility tests.

[0137] Staff will transfer the cells, contained in containers, into the CPC 604. Transfer can be delegated to a transfer specialist or CPC 604 staff, or it can be performed by the staff themselves. Transfers can be performed individually or by multiple people working together.

[0138] In CPC 604, a regenerative medical product 602 is manufactured from the received cells. In the manufacturing process, for example, cell culture is performed using a manufacturing apparatus located in a cleanroom. The manufactured regenerative medical product 602 is then transported in a frozen state to a cell preparation facility 606 or a cell preparation cart 608.

[0139] In cell preparation facility 606, the received regenerative medical products 602 are stored in a vault where cleanliness and temperature are managed. The vault may be located within cleanroom systems 606a or 608a, or it may be located externally.

[0140] Based on the timing derived from the date and time of the transplantation performed in hospital 610, regenerative medical product 602 is retrieved from the vault. Then, cell preparation is performed in cleanroom systems 606a and 608a. Examples of cell preparation include one or more processes selected from thawing, heating, activation, drug addition, container placement, and inspection including sterility testing.

[0141] Staff at cell preparation facility 606 or cell preparation vehicle 608 deliver the regenerative medical product 602, obtained from cell preparation, to hospital 610. Staff also assist with the transplantation of the regenerative medical product 602 as needed. As an auxiliary service, an example is verifying patient information, cell information, etc., registered in a computer against the patient and the regenerative medical product 602.

[0142] In this way, staff from the cell preparation facility 606 and the cell preparation vehicle 608 can travel to multiple hospitals 610 to support regenerative medicine. Therefore, it is convenient for the cell preparation facility 606 to be located near two, three, four, or five hospitals 610 that are its clients. Here, the range of "nearby" can be defined by the one-way travel time between the patient's treatment area in the hospital 610 and the cleanroom system 606a of the cell preparation facility 606. Specifically, examples can be given of 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 for commonly used modes of transportation selected from walking, cycling, motorcycles, cars, buses, trams, etc. To equalize deviations caused by signal waiting times, public transportation intervals, etc., travel time is measured by the average time required for multiple trips during the week and time period in which the transport is carried out. Alternatively, the range of "nearby" can be determined based on the distance or straight-line distance between the patient's treatment location in hospital 610 and the cleanroom system 606a of cell preparation facility 606, as described above, using the aforementioned movement method. Specifically, ranges within 20km, 15km, 10km, 8km, 6km, 2km, 1km, or 500m can be exemplified by the distance or straight-line distance.

[0143] The cell preparation vehicle 608 is capable of autonomous driving and moving towards the hospital 610. However, there is a limitation on the size of the cleanroom system 608a that can be mounted on the cell preparation vehicle 608. In cases where the vehicle has ample space, a buffer chamber can be installed in the cleanroom system 608a; however, to save space, only the cleanroom can be installed without a buffer chamber. The cleanroom system 608a is typically used when the cell preparation vehicle 608 is parked, but it is designed to be usable even while the vehicle is in motion.

[0144] The cleanroom systems 606a and 608a of the cell preparation facility 606 and cell preparation cart 608 have the simple exhaust mechanisms described above. Therefore, compared to conventional cleanrooms such as CPC 604, the manufacturing and maintenance costs of the exhaust mechanisms can be reduced. Since the number of cell preparation facilities 606 and cell preparation carts 608 needs to be increased compared to CPC 604, the introduction of the low-cost cleanroom systems 606a and 608a is of higher value.

[0145] The above description includes regenerative medicine product 602 related to autologous transplantation. Network delivery from CPC 604 to hospital 610 via cell preparation facility 606 or cell preparation vehicle 608 can also be widely used for regenerative medicine products related to allogeneic transplantation. These allogeneic transplantation-related regenerative medicine products are manufactured by CPC using cells derived from sources other than the recipient patient and stored in storage facilities as needed.

[0146] In the above description, cell preparation facility 606 and cell preparation vehicle 608 are facilities that support multiple hospitals 610. Alternatively, cell preparation facility 606 or cell preparation vehicle 608 can be facilities dedicated to each hospital 610. In the case of dedicated facilities, cell preparation facility 606 is considered to be located closer to the hospital 610 than in the example above. Specifically, as a nearby location, examples include locations where the travel time from cell preparation facility 606 to the treatment site is within 10 minutes, 5 minutes, 3 minutes, or 1 minute. In addition, examples of nearby locations include the same land, the same building, or the same ground level within the same building where cell preparation facility 606 and treatment site are connected. When cell preparation facility 606 or cell preparation vehicle 608 is installed in each hospital 610, the number of cleanroom systems 606a and 608a also increases, thus the advantage of using an exhaust structure that can be installed or maintained at a low cost is greater.

[0147] Label Explanation

[0148] 10: Cleanroom system; 20: Cleanroom; 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 surface opening; 46: HEPA filter; 50a, 50b, 50c, 50d, 50e, 50f: Flow path; 60: Exhaust fan; 62: HEPA filter; 70a, 70b, 70c: Air; 90: External; 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: Cleanroom system; 220: Cleanroom; 240: Safety cabinet; 250a, 250b, 250c, 250d, 250e, 250f: Flow path; 260: 261: Exhaust fan; 262: HEPA filter; 264: Workspace air supply fan; 310: Cleanroom system; 320: Cleanroom; 340: Isolator; 342: Workspace; 344: Glove box; 350a, 350b, 350c, 350d, 350e, 350f: Flow paths; 360: Exhaust fan; 362: HEPA filter; 370b: Air; 410: Cleanroom system; 420: Cleanroom; 440: Isolator; 450d1, 450d2, 450g: Flow path; 470b: Air; 510: Cleanroom system; 520: Cleanroom; 530: Air supply unit; 532: HEPA filter; 570: Air; 600: Network; 602: Regenerative medicine products; 604: CPC; 606: Cell preparation facility; 606a: Cleanroom system; 608: Cell preparation cart; 608a: Cleanroom system; 610, 610a, 610b, 610c, 610d: Hospital.

Claims

1. A cleanroom system, characterized in that, This cleanroom system has the following features: A cleanroom is airtight; An indoor air supply system that supplies air from the outside to the inside of the cleanroom; as well as The hazard response cabinet, located inside the cleanroom, includes a work space, a work space air supply path, a circulation path, a work space exhaust path, an exhaust fan, and a filter. The work space air supply path supplies air from inside the cleanroom to the work space. The circulation path draws in air from the work space and supplies it back. The work space exhaust path shares a portion with the circulation path but branches off midway to the outside, venting exhaust air from the work space to the outside of the cleanroom. The exhaust fan is located at the point where the circulation path and the work space exhaust path separate, driving the circulation in the circulation path and the exhaust in the work space exhaust path. The filter is located in the work space exhaust path and purifies the exhaust air. In the circulation path, no other fans are installed between the location where the exhaust fan is located and the workspace. The exhaust fan, which drives the circulation in the circulation path and the exhaust in the work space exhaust path, drives all the exhaust from the inside of the cleanroom to the outside and maintains the inside of the cleanroom at a negative pressure.

2. The cleanroom system according to claim 1, characterized in that, The cleanroom system has a bypass loop that connects to the exhaust duct of the workspace from inside the cleanroom without passing through the workspace itself. The exhaust fan also drives the air flowing in a circuitous path.

3. The cleanroom system according to claim 1, characterized in that, The hazard response cabinet mentioned is a safety cabinet. The workspace is the space for performing operations on biological objects.

4. The cleanroom system according to claim 1, characterized in that, The indoor air supply circuit is a natural air supply circuit that uses the negative pressure inside the cleanroom created by the exhaust fan as the driving force to supply air.

5. The cleanroom system according to claim 1, characterized in that, The workspace is the space used for processing regenerative medical products manufactured using cell culture processing facilities. The cleanroom system is located near the treatment area where the regenerative medical products are used.

6. The cleanroom system according to claim 5, characterized in that, The treatment facilities are scattered across more than two buildings. The cleanroom system is located in a location near the treatment site in at least two buildings.

7. A cleanroom system-equipped vehicle, characterized in that, The cleanroom system is equipped with vehicles that have the following features: The cleanroom system of claim 1; and The vehicle, which carries the cleanroom, The workspace is the space used for processing regenerative medical products manufactured using cell culture processing facilities. The vehicle is capable of moving to the vicinity of treatment sites where regenerative medicine products are used.

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