JP4632737B2 - Cell culture facility - Google Patents

Description

The present invention includes a working chamber for performing work related to cell preparation, an air supply duct for supplying clean air into the working chamber, and an exhaust duct for discharging after cleaning the air in the working chamber. Cell culture facilities.

  Research and development of disease treatment using therapeutic genes and regenerative medicine using cells have been promoted in recent years, and advanced medical care has been carried out with these therapeutic genes and cells, and there are great expectations for the results. It is sent. In this gene therapy, a recombinant gene called a vector that serves to carry a therapeutic gene is used. Vectors are often made by introducing a therapeutic gene into a virus.

  Originally, viruses have the property of releasing genes inside the virus when they infect cells. Therefore, when a vector having a therapeutic gene introduced therein is used, the therapeutic gene introduced into the virus is released when the vector virus infects cells to be treated. Therefore, the effect of gene therapy by a vector can be exhibited.

  Viruses are inherently pathogenic, and are very dangerous because they may be harmful to the human body. Since the virus or vector cannot be seen with the naked eye, its presence cannot be confirmed. Vector production and experiments are carried out in the work room, but in the production and experiment of vectors, a particularly important management item is to ensure safety to protect the human body from dangerous viruses. Unless these dangers to the human body are wiped out, it is impossible to produce vectors and conduct experiments with peace of mind.

  Therefore, the personnel and personnel engaged in the work room are protected from viruses, and when these personnel and personnel enter and exit the work room, the virus flows out of the work room through clothing, etc. It is necessary to prevent the inconvenience of being contaminated. In view of this, a cell culture facility has been proposed that can protect persons and persons in charge in the work room from viruses and prevent contamination of the surrounding environment of the work room.

  In this cell culture facility, cells that can be used for regenerative treatment are cultured, so aseptic management and aseptic operation is required, so workers enter the changing room from the entrance, and wear dust-free clothing there. After that, it is restricted to move each work room in the order of the preparation room, the first airlock front room, the vector production room, and the airlock back room, and then go through the sterilization room and take off the dustless clothes in the changing room. It is designed to move the flow line. In the sterilization chamber, all wastes and deliverables are sterilized with a high-pressure steam sterilizer before being carried outside. In this way, the human traffic line of workers and raw materials and tools necessary for vector production is restricted to one direction, preventing contact between workers before and after vector production, etc. It protects the people involved and the people in charge from viruses.

  Each work space is provided with a door and an adjusting means (for example, an air conditioner) for adjusting the pressure in each work chamber. Then, the pressure in the first airlock chamber is lower or higher than the pressure in the preparation chamber and the vector production chamber by the adjusting means, and the pressure in the airlock chamber is lower than the pressure in the vector production chamber and the sterilization chamber. The pressure in the vector preparation chamber and the sterilization chamber is maintained below atmospheric pressure. As a result, the pressure in the vector production chamber can be made the lowest compared with the pressure in other work chambers located around the vector production chamber, and the air in the vector production chamber (particularly contaminated air) leaks to the outside. This prevents the outflow of contaminated air from the vector production room where the highest physical containment level is required to the surrounding area (see Patent Document 1).

JP 2003-47457 A

  However, the conventional cell culture facility includes an air supply port for allowing air to flow into each working chamber and an outlet for allowing the air that has flowed out to flow out. In order for air to flow through the outlet, a duct must be secured around the outlet. For this reason, there was a problem that a space for the duct had to be secured around the outlet of the working chamber.

  The present invention has been made to solve the problems of the related art, and an object of the present invention is to provide a cell culture facility that can effectively use the space in the duct in the working chamber that was originally a surplus space. And

That is, the cell culture facility of the invention of claim 1 has purified a working chamber for performing work related to cell preparation, an air supply duct for supplying clean air into the working chamber, and air in the working chamber. And an exhaust duct for discharging the exhaust duct, and a portion of the exhaust duct located in the work chamber is an article storage capable of delivering articles, and the article storage is provided with air from the work chamber. Is provided with a suction port through which air flows in and an outlet through which air flowing in from the suction port flows out, a HEPA filter is provided at the outlet, and a germicidal lamp is disposed between the HEPA filter and the suction port, An air outlet of the air supply duct is provided at or near the ceiling of the work room, and a suction port is formed in the lower part of the article storage .

Moreover, the cell culture facility of the invention of claim 2 purifies the working chamber for performing work related to cell preparation, an air supply duct for supplying clean air into the working chamber, and the air in the working chamber. And an exhaust duct for discharging the exhaust duct, and a portion of the exhaust duct located in the work chamber is an article storage capable of delivering articles, and the article storage is provided with air from the work chamber. Is provided with a suction port through which air flows in and an outlet through which air flowing in from the suction port flows out, a HEPA filter is provided at the outlet, and a germicidal lamp is disposed between the HEPA filter and the suction port, A suction port is provided on the lower side of the article storage .

According to the first aspect of the present invention , since the portion of the exhaust duct located in the working chamber is an article storage capable of delivering articles, the space in the duct can be used, for example, for cleaning tools. . Therefore, the surplus space in the duct provided in each working chamber can be effectively used, and the convenience of the cell culture facility can be greatly improved.

In addition, the article storage is provided with a suction port through which air from the working chamber flows in and an outlet through which the air flowing in from the suction port flows out. A HEPA filter is provided at the outlet, and the HEPA filter Since the germicidal lamp is disposed between the suction port and the clean air sterilized by the germicidal lamp, only the clean air can pass through the HEPA filter. Thereby, inconveniences such as dangerous viruses adhering to the HEPA filter can be prevented, and air purification can be improved. Therefore, since the HEPA filter can be prevented from being contaminated with viruses, replacement and maintenance of the HEPA filter can be improved, and the life of the HEPA filter can be greatly extended.

Furthermore, since the air outlet of the air supply duct is provided at or near the ceiling of the work room, and the suction port is formed in the lower part of the article storage, a short circuit occurs between the air outlet and the air inlet of the air supply duct. It becomes difficult. Therefore, the air in each work chamber can be smoothly cleaned.

Further , according to the invention of claim 2 , similarly, the portion of the exhaust duct located in the working chamber is used as an article storage capable of delivering articles. For example, the space in the duct is used for cleaning tools. can do. Therefore, the surplus space in the duct provided in each working chamber can be effectively used, and the convenience of the cell culture facility can be greatly improved.

Similarly, the article storage is provided with a suction port through which air from the working chamber flows in and an outlet through which the air flowing in from the suction port flows out. A HEPA filter is provided at the outlet, and the HEPA Since the germicidal lamp is disposed between the filter and the suction port, only clean air sterilized by the germicidal lamp can pass through the HEPA filter. Thereby, inconveniences such as dangerous viruses adhering to the HEPA filter can be prevented, and air purification can be improved. Therefore, since the HEPA filter can be prevented from being contaminated with viruses, replacement and maintenance of the HEPA filter can be improved, and the life of the HEPA filter can be greatly extended.

Further, since the suction port is provided on the lower side of the article storage, the air in the working chamber moves toward the suction port on the lower side of the article storage. As a result, it becomes possible to prevent dangerous substances and contaminants from floating in the working chamber and sucking in by the worker, and to provide a safe cell culture facility.

  The present invention is characterized by effectively utilizing a space in a duct provided in a work chamber. The purpose of effectively utilizing the surplus space in the duct is realized by providing an article storage for storing cleaning tools in the surplus space in the duct.

  Next, embodiments of the present invention will be described in detail with reference to the drawings. FIG. 1 is a plan view of a cell culture facility showing an embodiment of the present invention, and FIG. 2 is a conceptual diagram of an article storage 18 provided in the cell culture facility showing an embodiment of the present invention. The cell culture facility of the present invention is a facility for culturing cells that can be used in gene therapy / regenerative therapy, and is provided with a plurality of work rooms for performing work related to cell preparation. This working room is composed of a preparation room 3, an airlock front room 5, a cell preparation room 2, a dressing room 7 (a degauning room), and the like. Each of these working rooms is an indispensable room for cell preparation and vector preparation. In addition, the material storage room 16, the clothing room 10 (secondary degauning room), the sterilization room 8, and the cells and vectors are stored. Work rooms such as a cell storage room 12, a quality control room 13, and a data management room 14 are provided. The data management room 14 also serves as a control room for monitoring and controlling the entire facility. Each of these rooms is housed in one building 1.

  Next, an arrangement example of each room when the building 1 is viewed from above will be described. As shown in FIG. 1, the building 1 is formed in a horizontally long and substantially rectangular shape, and the entrance 40 is arranged at a position slightly closer to the left side than the lower center in the figure. The preparation room 3 is formed in a horizontally long and substantially rectangular shape, and is arranged in the lower right corner of the building 1. A cell preparation chamber 2 is disposed above the preparation chamber 3. The cell preparation chamber 2 is composed of a first cell preparation chamber 2A having a vertically long and substantially rectangular shape and a second cell preparation chamber 2B which is also a vertically long and substantially rectangular shape. The number of cell preparation chambers 2 may be one, or three or more.

  The first cell preparation chamber 2A is arranged at the right end of the building 1, and the second cell preparation chamber 2B is arranged on the left side of the first cell preparation chamber 2A. A hallway 42 is disposed above the second cell preparation chamber 2B with a partition wall K3 therebetween, and the first cell preparation chamber 2A is disposed on the right side of the hallway 42 with a partition wall K4 therebetween. The preparation chamber 3 is disposed on the lower side across the first and second cell preparation chambers 2A and 2B and the partition walls K1 and K5. The airlock front chamber 5 is formed in a substantially rectangular shape, and is disposed on the lower left side in the first cell preparation chamber 2A. The undressing chamber 7 is also formed in a substantially rectangular shape, and is disposed at the upper right in the second cell preparation chamber 2B. The undressing chamber 7 also serves as an air lock chamber.

  The material storage chamber 16 is disposed across a partition wall K2 provided on the left side of the preparation chamber 3 and a partition wall K5 provided on the lower side of the second cell preparation chamber 2B. The material storage chamber 16 is formed in an L shape from approximately the center on the left side of the second cell preparation chamber 2B to approximately the center on the lower side of the second cell preparation chamber 2B. A horizontally elongated clothes room 10 is disposed between the preparation room 3 and the material storage room 16, and the partition wall K2 is provided between the clothes room 10 and the second cell preparation room 2B.

  A vertically long rectangular data management room 14 is arranged on the left side of the entrance 40, and a substantially rectangular quality management room 13 is arranged on the left side of the data management room 14 with a partition wall K6 therebetween. A substantially rectangular cell storage chamber 12 is disposed above the data management chamber 14 and the quality control chamber 13 with a partition wall K7 therebetween. A changing room 17 (primary degauning room) is disposed above the entrance 40 with a door D2 therebetween, and a corridor 42 is disposed above the door 40 with the door D17 therebetween.

  The sterilization chamber 8 is formed in a substantially rectangular shape and is arranged in the upper left corner of the corridor 42. The corridor 42 disposed across the door D17 above the changing room 17 bypasses the sterilization room 8 along the material storage room 16 and continues to the upper side of the second cell preparation room 2B. In addition, a horizontally elongated changing room 44 is disposed adjacent to the data management room 14 at the lower right of the quality control room 13.

  Next, main work rooms will be described. In the cell preparation room 2, cells that can be used for disease treatment research using genes, research and development of new drugs, or regenerative treatment are cultured. Examples of cells that can be used in regenerative treatment include embryonic stem cells, neural stem cells, and adult stem cells. In cell preparation chamber 2, for example, corneal cell production / vector production is one of the cells used in regenerative treatment. Cell preparation and vector production are performed. Further, in this working room, processing such as deletion of viral pathogenicity, extraction of therapeutic genes, integration with viral genes, or preparation / exchange of media is performed. In the first cell preparation chamber 2A, there is provided a safety cabinet 32 provided with a special air conditioner for safely handling dangerous viruses. In the safety cabinet 32, for example, an openable / closable door is provided at the front opening of the housing, and a work table is provided in a work space formed inside.

  The working space is controlled to a negative pressure by the air conditioner than the first cell preparation chamber 2A so that dangerous viruses handled in the safety cabinet 32 do not leak outside (in the first cell preparation chamber 2A). Is considered. A similar safety cabinet 32 is also provided in the second cell preparation chamber 2B and the quality control chamber 13. In addition, a filter having an action of capturing microorganisms is attached to the air exhaust system in the safety cabinet 32. A HEPA filter 50 (high-efficiency particulate air) is suitable as the type of filter. The technology in which the safety cabinet 32 is safely constructed against viruses and vectors is a well-known technology and will not be described in detail.

  Cell preparation and vector production work in the cell preparation chamber 2 can be performed by placing raw materials and instruments in the safety cabinet 32 and inserting the hand from the cell preparation chamber 2 side through rubber gloves or the like. It has become. Therefore, there is a low risk that pathogenic viruses and gene transfer vectors that are hidden in the cells will leak into the cell preparation chamber 2 during the operation. However, since cell handling and vector culture are performed in the cell preparation chamber 2 before and after the operation, the cell preparation chamber 2 is the place with the highest risk. Measures for avoiding this danger, that is, measures for ensuring safety will be described later.

  The material storage chamber 16 stores materials necessary for production of vectors and stores instruments. The preparation room 3 is a working room for performing preparation for vector production, preliminary processing, pre-process, and the like. Since the preparation chamber 3 needs to minimize the complicated processing in the cell preparation chamber 2, the operation of handling the virus necessary for the production of the vector, the gene for recombination, the equipment necessary for the operation, the container, etc. is smoothly performed. Make preparations to do it.

  The sterilization room 8 is a work room for sterilizing instruments used for cell preparation and vector production work and waste that may be contaminated. The sterilization chamber 8 is equipped with a high-pressure steam sterilizer (not shown) for performing sterilization before it is carried out of the building 1 so that dangerous substances and contaminants do not go outside. It has been. Moreover, the autoclave process (sterilization process) by a high pressure steam sterilizer is a process for improving the certainty of a sterilization process further, and it is good to process on the conditions of +1.2 atmospheres and +121 degreeC.

  The airlock front chamber 5 prevents the air in the cell preparation chamber 2 (in this case, air in which dangerous substances or contaminants may float) from leaking into the preparation chamber 3. It is a work room for doing. Moreover, the undressing room 7 is a room which changes the dust-free clothes (work clothes) worn at the time of work. There is a danger if a dust-free garment that may be contaminated in the cell preparation chamber 2 is taken out of the undressing chamber 7. Therefore, the dressing room 7 is provided with a sterilizer 30 for sterilizing the dust-free garment with high-pressure steam, and the dust-free garment removed in the dressing room 7 is sterilized by the sterilizer 30.

  The dust-free clothing sterilized by the sterilizer 30 in the undressing room 7 is taken out after a predetermined time or longer (about 1 to 2 hours) and placed in the locker 36 provided in the changing room 17 or in the material storage room 16. It is carried into a locker (not shown) provided and used again. This prevents the danger that the dust-free garment once taken off is taken out of the undressing chamber 7 and worn again. Further, since the removed dust-free garment can be used again by sterilizing with the sterilizer 30, the waste of the dust-free garment is eliminated, and the cost can be reduced.

  The changing room 17 is a room for removing the outerwear such as storage of a dust-free garment or a coat, and the clothing room 10 is a room for wearing a dust-free garment necessary for work in the first and second cell preparation rooms 2A and 2B. It is. The cell storage room 12 is a room for temporarily storing a vector as a product, and the quality control room 13 is a room for conducting quality control of the vector and quality control in the manufacturing process. The data management room 14 is a room for monitoring the air pressure in the entire cell culture facility and the working room and controlling it so as to maintain a normal state, and is a working room that functions as a centralized data management room.

  Here, since the cell culture facility handles dangerous vectors, it is necessary to prevent the contaminated air in each room from flowing out to other work rooms. In this case, by providing a differential pressure space in front of and behind the working chamber that passes through the human flow line, the contaminated air is prevented from flowing out to other working chambers. That is, the airlock front chamber 5 has a role as a barrier to the front and rear working chambers (preparation chamber 3 and first and second cell preparation chambers 2A and 2B), and the cell preparation chamber 2 (vector production chamber). The air in which the potentially dangerous substances and pollutants may float is prevented from leaking into the preparation chamber 3. In addition, the air lock chambers such as the air lock front chamber 5 and the dressing chamber 7 block the air flow between the work chambers arranged on the front and rear sides of the air lock chamber and buffer the front and rear with respect to the work chamber. Play the role of space.

The working chambers on both sides of the buffer space are either higher or lower than the buffer space. Therefore, in the cell culture facility, a blower (not shown) provided in an air supply duct , which will be described later, and a blower 48 provided in the duct 46 are driven and controlled, so that the air conditioner is connected to each room from the air supply duct. By adjusting the amount of air blown out to the outside and the amount of air discharged from the exhaust duct to the outside of the building 1, a differential pressure is provided for each indoor pressure, and each is controlled to a predetermined physical containment level. That is, in the embodiment, for example, the first cell preparation chamber 2A is ± 0 Pa, the second cell preparation chamber 2B is ± 0 Pa, the airlock front chamber 5 is +30 Pa, the undressing chamber 7 is −30 Pa, the preparation chamber 3 is +15 Pa, and the dressing chamber 10 +30 Pa, material storage room 16 +15 Pa, corridor 42 +15 Pa, changing room 17 +15 Pa, sterilization room 8 +15 Pa, cell storage room 12 ± 0 Pa, quality control room 13 ± 0 Pa, data management room 14 +15 Pa The entrance 40 is at atmospheric pressure. Since the technology for controlling the pressure in each room to a physical containment level by such an air conditioner is a well-known technology, detailed description thereof will be omitted.

  As described above, the airlock front chamber 5 is set to a positive pressure from the cell preparation chamber 2 and the negative pressure from the preparation chamber 3, and the undressing chamber 7 is set to a negative pressure from the cell preparation chamber 2 and the corridor 42. In this case, the air in the airlock front chamber 5 flows into the cell preparation chamber 2, so that the air in the cell preparation chamber 2 can be prevented from leaking into the preparation chamber 3 through the airlock front chamber 5. Moreover, since the air in the corridor 42 flows into the undressing chamber 7, it is possible to prevent the air in the cell preparation chamber 2 from leaking into the corridor 42 through the undressing chamber 7. Thereby, it is possible to block leakage of dangerous substances from the cell preparation chamber 2 to the airlock front chamber 5 and the undressing chamber 7. Accordingly, it is possible to reliably prevent the vector prepared in the cell preparation chamber 2 or contaminants that are likely to float in the air from leaking out of the cell preparation chamber 2.

  On the other hand, an article storage 18 is provided in a place that does not interfere with each room, and a duct (shown in FIG. 3) is formed in the article storage 18. The article storage 18 has a rectangular tube shape that can deliver articles, and the article storage 18A is located in the upper right corner of the first cell preparation chamber 2A, and the article storage is located in the upper left corner of the second cell preparation chamber 2B. 18B is provided. Further, an article storage 18C is provided above the material storage chamber 16, an article storage 18D is provided in the upper right corner of the cell storage chamber 12, and an article storage 18E is provided in the lower right corner of the quality control room 13. In these article storage boxes 18, a cleaning tool for sterilization cleaning (such as a mop) used in each room can be stored. From the viewpoint of cleanliness and physical containment, the cleaning tool is, in principle, a disposable type, and is discarded after sterilization after use. The article storage boxes 18 and 18A to 18E are configured substantially the same. In addition, the article storage 18 may store other items used in each room other than the cleaning tool, but since the article storage 18 is a duct, it is stored so as not to block the inside of the article storage 18. There is a need to.

  When the vector production work is performed in this cell culture facility, the workers and the raw materials and the tools necessary for vector production are shown in FIG. 1 from the entrance 40 to the changing room 17 and the material storage room 16. , Enters the preparation room 3 through the dressing room 10, and moves through the chambers in the order of the airlock front room 5, the cell preparation room 2 (one of the first and second cell preparation rooms 2A, 2B) and the dressing room 7. . Then, a restricted human flow line is formed which flows in one direction from the dressing room 7 to the hallway 42 and back to the entrance 40. The entrance 40 allows entry into the changing room 17, the data management room 14, the changing room 44, and the quality control room 13, and the corridor 42 allows access to the cell storage room 12, sterilization room 8, undressing room 7, and changing room 17. It has become. The left and right and front doors D9, D10, D11 of the dressing room 7 are constituted by electronic locks with interlocks, and at the same time any one door is opened, the other doors are not opened.

  In addition, each working chamber is individually adjusted for the indoor pressure (the indoor pressure will be described in detail later). For this purpose, doors for partitioning the respective chambers are provided on the inlet side and the outlet side of the respective chambers. An entrance door D1 is provided at the entrance of the entrance 40, a door D2 as described above is provided between the entrance 40 and the changing room 17, and a door D3 is provided between the changing room 17 and the material storage room 16. A door D 4 is provided between the material storage chamber 16 and the clothing room 10, and a door D 5 is provided between the clothing room 10 and the preparation room 3. The doors D4 and D5 before and after the clothing room 10 are also constituted by electronic locks with an interlock, and when one door is opened, the other doors are not opened simultaneously. Further, when any one of the doors around the entrance 40 (entrance door D1, door D2, D12) and the door of the work room provided with the entrance and the exit is opened, the other doors are not opened. ing.

  Between the preparation chamber 3 and the airlock front chamber 5, the door D6, and between the airlock front chamber 5 and the cell preparation chamber 2 (first cell preparation chamber 2A), the door D7, the airlock front chamber 5 and the cell preparation. A door D8 is provided between the chambers 2 (second cell preparation chamber 2B). Further, a door D12 is provided between the entrance 40 and the data management room 14, a door D13 is provided between the data management room 14 and the changing room 44, and a door D14 is provided between the changing room 44 and the quality control room 13. Yes. A door D15 is provided between the corridor 42 and the cell storage chamber 12, and a door D16 is provided between the corridor 42 and the sterilization chamber 8. And these doors are provided in the partition wall in each chamber, or its vicinity.

  Further, a partition wall K2 that partitions the material storage chamber 16 and the preparation chamber 3, a partition wall K1 that partitions the preparation chamber 3 and the first cell preparation chamber 2A, and a partition wall K5 that partitions the preparation chamber 3 and the second cell preparation chamber 2B. A product delivery port 34 is provided in each of the partition wall K4 that partitions the first cell preparation chamber 2A and the hallway 42, and in the partition wall K3 that partitions the second cell preparation chamber 2B and the hallway 42. These product delivery ports 34 are prepared from the material storage chamber 16 to the preparation chamber 3, from the preparation chamber 3 to the first cell preparation chamber 2A, and from the first cell preparation chamber 2A to the corridor 42 as shown by the dotted arrows in FIG. These are movement lines for moving an object from the chamber 3 to the second cell preparation chamber 2B and from the second cell preparation chamber 2B to the corridor 42.

  The product delivery port is also provided in a partition wall K8 that partitions the corridor 42 and the cell storage chamber 12, a partition wall K7 that partitions the cell storage chamber 12 and the quality control chamber 13, and a partition wall K9 that partitions the corridor 42 and the material storage chamber 16. 34 is provided. These product delivery ports 34 are used to move objects from the corridor 42 to the cell storage chamber 12, from the cell storage chamber 12 to the quality control room 13, and from the corridor 42 to the material storage chamber 16, as indicated by the dotted arrows in FIG. This is the flow of movement. The cell storage chamber 12 and the quality control chamber 13 are determined in installation position and door position so that the operator can enter and exit without entering the material storage chamber 16 or the preparation chamber 3.

  The cell culture facility according to the present invention having the above configuration will be described in detail below. The cell culture facility shown in FIG. 1 is a facility according to a preferred embodiment of the present invention. The cell culture facility is designed to perform all of preparation for vector production, vector production, vector storage, quality control, and the like in one building 1. Furthermore, it is designed so that workers and raw materials / products flow in one direction.

  There is a changing room 17 inside the entrance 40, and the changing room 17 is entered through the entrance door D1 and the entrance door D2 of the changing room 17. The preparation room 3 is provided next to the changing room 17 via the material storage room 16 and the dressing room 10, and from the changing room 17 to the material storage room 16 via the door D3, and from the material storage room 16 to the door D4. It moves to the preparation room 3 via the door D5 from the clothing room 10 via the door D5.

  From the preparation chamber 3, it moves to the 1st cell preparation chamber 2A via the door D6 via the door D6 and the air lock front chamber 5 via the door D7. Further, the air lock front chamber 5 moves to the second cell preparation chamber 2B through the door D8.

  The downstream side in the process with respect to the first cell preparation chamber 2A is movable to the dressing room 7 via the door D9, and the downstream side in the process with respect to the second cell preparation chamber 2B is movable to the dressing room 7 through the door D10. The undressing room 7 is a working room for removing the dust-free clothes worn during the work in the first and second cell preparation rooms 2A and 2B and immediately sterilizing them so that the contaminated dust-free clothes are not taken out. The undressing chamber 7 is provided with a high-pressure steam sterilizer 30 for sterilizing the dust-free garment. The time for sterilizing the dust-free garment in the sterilizer 30 is about 1 to 2 hours as described above.

  The dressing room 7 can be moved to the hallway 42 through the door D11 and from the hallway 42 into the dressing room 7. As a result, the dust-free clothing sterilized by the sterilizer 30 can enter the undressing chamber 7 from the corridor 42 and be taken out. Further, the sterilization chamber 8 is entered from the corridor 42 through the door D16, and can be exited from the door D16 to the corridor 42.

On the other hand, the cell culture facility is provided with an air conditioner (not shown) for adjusting the indoor pressure of each room. The air conditioner includes a blower that blows air into each room, and a blower 48 (shown in FIG. 2) that discharges the air in each room to the outside of the building 1. By the air conditioner, it is supplied to each chamber from the building block 1 out of the air supply duct (not shown) to clean the air, cleaned suck each chamber of air to the exhaust duct 28 (FIG. 2 shown) building block 1 Each room is cleaned by discharging it outside. An air outlet 26 for blowing air into each room is provided in the ceiling of each room or in the vicinity of the ceiling, and this air outlet 26 communicates with an air supply duct of the air conditioner. FIG. 1 is a plan view of the cell culture facility, but also shows an air outlet 26 provided on the ceiling or in the vicinity of the ceiling.

  As shown in FIG. 2, the article storage case 18 is provided with a suction port 20 substantially in contact with the floor surface, and a louver plate 21 is provided at the suction port 20. The louver plate 21 is provided in the lower part of the article storage 18 or in the vicinity of the lower part (in this case, the floor surface of the first cell preparation chamber 2A or in the vicinity of the floor surface), and the louver plate 21 is provided in the first cell preparation chamber. It is provided facing 2A. The inside of the first cell preparation chamber 2 </ b> A communicates with the inside of the article storage box 18 through the louver plate 21. An opening / closing door 19 that can be opened and closed together with a louver plate 21 for storing a cleaning tool or the like in the article storage 18 is provided on the front surface of the article storage 18. In addition, it is preferable to arrange | position the blower outlet 26 and the suction inlet 20 in the same room | chamber interior, and the position spaced apart as much as possible. As a result, it is possible to prevent a so-called short circuit in which the air blown out from the air outlet 26 is directly sucked in from the air inlet 20.

An outlet 22 is formed in the upper part of the article storage 18 </ b> A, and a duct 46 that opens to the outside of the building 1 communicates with the outlet 22. That is, the duct 46 forms an exhaust duct 28 that communicates from the suction port 20 provided in each room to the outside of the building 1 through the article storage 18 and the outlet 22. The outlet 22 is provided with a HEPA filter 50 capable of removing dust in micron units and removing viruses. Further, a germicidal lamp 52 is provided in the article storage case 18 </ b> A, and this germicidal lamp 52 is provided below the HEPA filter 50 between the HEPA filter 50 and the suction port 20. The germicidal lamp 52 illuminates the entire HEPA filter 50 and the article storage 18A, and prevents viruses and bacteria from propagating from cleaning tools and the like stored in the HEPA filter 50 and the article storage 18A.

  The blower 48 is disposed in the duct 46. When the blower 48 is operated, the air in the first cell preparation chamber 2A is sucked into the article storage 18A (in the duct 46) from the suction port 20 as shown by the white arrow in FIG. In the process of passing through the HEPA filter 50, dust and viruses are trapped by the HEPA filter 50 in the process of passing through the HEPA filter 50, and the purified air becomes purified air from the opening of the duct 46 to the outside of the building 1 Discharged. Further, the air sucked into the article storage 18A is sterilized by the sterilization lamp 52 provided in the article storage 18A, and the virus caught by the HEPA filter 50 is also sterilized by the sterilization lamp 52. Thereby, inconveniences such as dangerous viruses passing through the HEPA filter 50 can be prevented, and air purification can be improved. Therefore, the danger that the air contaminated with the virus is discharged from the duct 46 to the outside of the building 1 can be reliably prevented. The article storage boxes 18B, 18C, 18D, and 18E provided in the other chambers are similarly configured. Moreover, it is desirable that the air outlet 26 and the article storage 18 are provided in each chamber. However, as described above, it is not necessarily provided in all the rooms.

Thus, since the cell culture facility uses the duct 46 portion located in the working chamber of the exhaust duct 28 as the article storage 18 capable of delivering articles, it is used for putting a cleaning tool in the article storage 18. can do. Thereby, the surplus space of the exhaust duct 28 in each work chamber can be effectively used, and the convenience of the cell culture facility can be greatly improved.

  In addition, the article storage case 18 includes a suction port 20 through which air from the work chamber flows in and an outflow port 22 through which air that flows in from the suction port 20 flows out. Since the HEPA filter 50 is provided at the outlet 22 and the sterilization lamp 52 is provided between the HEPA filter 50 and the suction port 20, clean air sterilized by the sterilization lamp 52 is supplied to the HEPA filter 50. Can flow in. As a result, it is possible to prevent the inconvenience that the HEPA filter 50 is contaminated with viruses, so that the air cleaning can be greatly improved.

Further, the air outlet duct 26 is provided at or near the ceiling of each work room, and the suction port 20 is formed near the floor surface of the lower part of the article storage case 18 spaced from the air outlet 26. In this case, it is possible to prevent inconveniences such as that it becomes impossible to clean each work chamber by the short circuit in which the air blown out from the air outlet 26 is directly sucked from the air inlet 20. Thereby, the air in each work chamber can be smoothly cleaned, and the safety in each work chamber can be ensured reliably.

  Next, FIG. 3 shows another cell culture facility of the present invention. The cell culture facility has substantially the same configuration as the above-described embodiment. Hereinafter, different parts will be described. The same parts as those in the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted. Cell culture facilities such as those described above must safely handle cells and viruses that can be dangerously pathogenic. Therefore, as shown in FIG. 3, the cell culture facility color-codes the floor surface of each work room in accordance with the cleanliness in the work room.

  Here, the air cleanliness in each working chamber is classified into four zones A to D to improve safety. The standard for managing cleanliness is described in the document “EU-GMP, Japanese Pharmacopoeia (14th revised Japanese Pharmacopoeia, Part 2 Reference Information, published in 2001)” and the latest version of EU-GMP According to (May 30, 2003), the place where the product is exposed to air and operated (in the safety cabinet 32) is set to a class 100 cleanliness. Such zone A indicates the highest cleanliness, less than CLASS100, zone B indicates the next highest cleanliness less than CLASS10000, zone C indicates the next highest cleanliness B, less than CLASS10000000, Zone D shows CLASS100,000 or more with the lowest cleanliness.

  That is, according to the present invention, each room is divided into different colors according to the cleanliness zone so that the work can be performed safely in the cell culture facility, so that the person concerned or the operator can easily grasp the risk of the place. I have to. The color classification is performed by coloring the floor of each room. As for the division color, the highest zone A is in the safety cabinet 32 and there is no floor surface, and there is no floor coloration (horizontal parallel lines in the figure). Pink color (vertical and horizontal dotted lines at approximately equal intervals in the figure), the floor surface of zone C with the next highest cleanliness is green (hatched diagonal lines in the figure), and the floor surface of zone D with the lowest cleanliness is gray ( It is colored (hatched).

  In the cell culture facility, since most of the workers are women, the color of the floor surface of Zone B is a warm pink. The worker works in each sealed room, but the image received from the pink color has a feeling of openness, so how to create the feeling of opening in a narrow space is a very important factor. Among the warm colors, “red, orange, yellow”, which includes half of the hue circle, pink and brown, are colors that make you feel warm. In particular, pink is said to have a calming effect on women. ing. Thereby, the work efficiency of the worker can be improved in a narrow work room.

  Further, when the floor surface of the zone C is made green, it is possible to feel a more comfortable (clean feeling) than the gray working room of the zone D. Thereby, it is possible to work calmly and to improve the work efficiency of the worker. Further, when the floor surface corresponding to the zone D is made gray, it is possible to imagine an opaque meaning that is not well understood whether it is clean or not. As a result, it is easy to see that it is not a work room and is convenient. In addition, when the pink floor surface of the zone B is changed to the amber system which is a gray system, it is very difficult to visually recognize that it is contaminated with the contaminants. If it is pink, it is easy to visually recognize that the floor surface is contaminated with contaminants, and it is possible to prevent dangers such as contaminants being scattered to others.

  Thus, since the floor surface of each work room is color-coded according to the cleanliness, the cleanliness of each work room can be grasped by the color of the floor surface. Thereby, the worker can easily know whether he / she has entered the working room having a special cleanliness level, and the worker himself can be aware of which cleanliness zone he / she is working in. Therefore, the operator can grasp the cleanliness of each work room clearly by the color of the floor surface, and can work very safely in the work room of each zone. In particular, the floor of each room is color-coded according to cleanliness, so do not lean on walls, equipment, desks, etc. in high-risk areas, do not lean on hands, take off gloves, and minimize conversation It will be possible to work safely by minimizing actions and actions that lead to danger, such as limiting to the limit.

  Moreover, since the floor surface of the work room (cell preparation room 2) with a high cleanliness is warm-colored pink, the health degree of the worker can be improved and the work efficiency can be improved. In particular, since most of the workers are women, the feeling of women can be calmed by making the floor surface pink. Moreover, a vector can be produced safely and with high productivity by configuring a cell culture facility as described above. Therefore, the work efficiency can be further improved.

  Next, FIG. 4 shows another cell culture facility of the present invention. The cell culture facility has substantially the same configuration as each of the embodiments described above. Hereinafter, different parts will be described. The same parts as those in the above-described embodiment are denoted by the same reference numerals, and description thereof is omitted. The cell culture facility according to another embodiment of the present invention is provided with the air conditioner 56 for each room as shown in FIG.

In the figure, the upper side shows the cell preparation chamber 2, the lower side shows the cell storage chamber 12, and the lower side shows the material storage chamber 16, and an air conditioner 56 is provided in each of these chambers. The air conditioner 56 has a blower (not shown) for blowing air into each room as described above, and a blower 48 (shown in FIG. 2) that discharges the air in each room to the outside of the building 1. An air outlet 26 is provided in the ceiling of the first cell preparation chamber 2A (cell preparation chamber 2) or near the ceiling, and an article storage 18A (article storage 18) is provided in the first cell preparation chamber 2A. . The outlet 26 is connected to an air conditioner 56A (air conditioner 56) via the air supply duct 24, and the article storage 18A is connected to the air conditioner 56A via the exhaust duct 28.

Similarly to the first cell preparation chamber 2A, the cell storage chamber 12 is provided with an air outlet 26 at or near the ceiling in the cell storage chamber 12, and an article storage 18D (article storage 18) is provided in the cell storage chamber 12. It has been. The outlet 26 is connected to the air conditioner 56B (air conditioner 56) via the air supply duct 24, and the article storage 18D is connected to the air conditioner 56B via the exhaust duct 28.

Similarly to the first cell preparation chamber 2A, the material storage chamber 16 is provided with an air outlet 26 at or near the ceiling in the material storage chamber 16, and an article storage 18C (article storage 18) is provided in the material storage chamber 16. It has been. The air outlet 26 is connected to an air conditioner 56C (air conditioner 56) via the air supply duct 24, and the article storage case 18C is connected to the air conditioner 56C via the exhaust duct 28.

The air conditioner 56 controls the air blower (not shown) provided in the air supply duct 24 and the air blower 48 provided in the duct 46 to control the amount of air blown from the air supply duct 24 into each room. Then, the amount of air discharged from the exhaust duct 28 to the outside of the building 1 is adjusted, and each indoor pressure is controlled to a predetermined cleanliness. The article storage 18 provided in each room is provided at a position as far away as possible from the air outlet 26 or in the vicinity of the separated position. Thereby, the short circuit from which the air blown out from the blower outlet 26 is sucked in from the suction inlet 20 provided in each goods storage 18 as it is can be prevented suitably. As a result, it is possible to prevent inconveniences in cleaning the work chambers, and to ensure the safety of the work chambers.

  Further, since the air outlet 26 is provided on the ceiling or in the vicinity of the ceiling, and the suction port 20 is provided substantially in contact with the floor surface, the air blown from the air outlet 26 moves toward the lower suction port 20. Thereby, it is possible to prevent dangerous substances and contaminants from floating. Therefore, it is possible to reliably prevent inconveniences such as the operator handling the vector that is handled on the workbench at the time of vector production, the substance that is likely to float in the working room, and the contaminants, A cell culture facility with safety can be provided.

As described above, since the air conditioner 56 is provided in each chamber (the cell preparation chamber 2, the cell storage chamber 12, and the material storage chamber 16), the air circulated through each chamber is supplied to the air conditioner 56 in another work chamber. Inflow into the air duct 24 and the exhaust duct 28 can be prevented. This makes it possible to avoid cross-contamination with respect to each room, so that, for example, one room may be accidentally accidentally compared to the case where the air in a plurality of rooms is cleaned to a predetermined cleanliness by a single air conditioner 56. It is possible to reliably prevent the danger that the contaminated air is blown out into another room. Therefore, each room can be managed extremely safely. In Example 3, each chamber is described as the cell preparation chamber 2, the cell storage chamber 12, and the material storage chamber 16, but each of the other chambers is similarly provided with an air conditioner 56, respectively. Thus, the air in each chamber can be cleaned to a predetermined cleanliness. However, as described above, the air conditioners 56 are not necessarily provided in all the rooms.

  In the examples, the cell culture facility has been described by the production of a vector. However, the cell culture facility is not limited to the production of a vector, but in other dangerous bacterial culture experiments, dangerous gases and chemicals, or recombinant DNA experiments. The present invention is also effective.

  Moreover, although the blower outlet 26 and the article | item storage 18 were provided in one place in each room, the blower outlet 26 and the article | item storage 18 are not restricted to one place in each room, and may provide multiple places. In this case, since the flow velocity of the blower outlet 26 and the article storage case 18 and the wind speed blown into each room can be suppressed, inconveniences such as invisible dust and dust rising by the air blown from the blower outlet 26 can be prevented. Can do. Thereby, it is possible to prevent inconveniences such as floating of the vector or scattering around the vector at the time of vector production, and the convenience of the cell culture facility can be greatly improved. Further, by providing a plurality of outlets 26 and the article storage case 18, it becomes possible to clean each room in a short time. As a result, the spread of contamination in each room can be minimized, and the safety in each room can be reliably ensured.

  Further, in Example 1, the airlock front chamber 5 is set to a positive pressure from the cell preparation chamber 2 and the negative pressure from the preparation chamber 3, and the dressing chamber 7 is set to a negative pressure from the cell preparation chamber 2 and the corridor 42, thereby Although some contaminants were prevented from leaking out of the cell preparation chamber 2, the cell preparation chamber 2 was set to a positive pressure, the airlock front chamber 5 was set to a negative pressure from the cell preparation chamber 2, and the preparation chamber 3 was set to air. A positive pressure may be applied from the lock front chamber 5, a negative pressure may be applied to the dressing chamber 7 from the cell preparation chamber 2, and a corridor 42 may be set to a positive pressure from the dressing chamber 7. Further, the cell preparation chamber 2 is set to a negative pressure, the airlock front chamber 5 is set to a positive pressure from the cell preparation chamber 2, the preparation chamber 3 is set to a negative pressure from the airlock front chamber 5, and the dressing room 7 is set to the cell preparation chamber 2. The positive pressure and the corridor 42 may be set to a negative pressure from the dressing room 7. Thereby, since the airlock front chamber 5 and the dressing chamber 7 can serve as a barrier, it is possible to prevent dangerous contaminants from leaking out of the cell preparation chamber 2.

  The present invention is not limited to the above-described embodiments, and it goes without saying that various modifications can be made without departing from the scope of the invention.

It is a top view of the cell culture facility which shows one Example of this invention (Example 1). It is a conceptual diagram of the article | item storage provided in the cell culture facility which shows one Example of this invention. It is a top view of the cell culture facility which shows the cleanliness of each room which is one Example of this invention (Example 2). It is a schematic diagram of the cell culture facility which shows one Example of this invention (Example 3).

DESCRIPTION OF SYMBOLS 1 Building 2 Cell preparation room 2A 1st cell preparation room 2B 2nd cell preparation room 3 Preparation room 5 Airlock front room 7 Dressing room 8 Sterilization room 10 Dressing room 12 Cell storage room 13 Quality control room 14 Data management room 16 Material Storage room 17 Changing room 18 Goods storage 20 Suction port 22 Outlet 24 Air supply duct 26 Air outlet 28 Exhaust duct 30 Sterilizer 32 Safety cabinet 34 Product delivery port 42 Corridor 46 Duct 48 Blower 50 HEPA filter 52 Sterilization light

Claims (2)

A cell comprising: a work chamber for performing work related to cell preparation; an air supply duct for supplying clean air into the work chamber; and an exhaust duct for discharging the air after cleaning the air in the work chamber In the culture facility,
A portion of the exhaust duct located in the work chamber is used as an article storage capable of delivering articles, and a suction port through which air from the work chamber flows into the article storage, and flows from the suction port. An air outlet from which air flows out, a HEPA filter provided at the outlet, a germicidal lamp disposed between the HEPA filter and the inlet,
A cell culture facility characterized in that an air outlet of the air supply duct is provided at or near the ceiling of the work chamber, and the suction port is formed at a lower portion of the article storage . A cell comprising: a work chamber for performing work related to cell preparation; an air supply duct for supplying clean air into the work chamber; and an exhaust duct for discharging the air after cleaning the air in the work chamber In the culture facility,
A portion of the exhaust duct located in the work chamber is used as an article storage capable of delivering articles, and a suction port through which air from the work chamber flows into the article storage, and flows from the suction port. An air outlet from which air flows out, a HEPA filter provided at the outlet, a germicidal lamp disposed between the HEPA filter and the inlet,
A cell culture facility characterized in that the suction port is provided below the article storage case .

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