Aseptic Processing System

Abstract

To provide a sterile work system that can ensure the reliability of work in a sterile environment by confirming and recording the contamination status of specific parts of a robot arm that are likely to come into contact with powder, liquid, cells, etc. when working in a sterile environment, and the contamination status of foreign matter, dust, etc. generated from or attached to the specific part of the robot arm, and by locally decontaminating or locally cleaning the specific part of the robot arm when contamination is detected. [Solution] A robot and a robot arm inspection device are installed inside a sterile work room. The robot arm is moved into a sampling pod during the middle or end of the sterile work. Dust generation and contamination from the robot arm are detected by a contamination detection device. The robot arm is decontaminated inside the sampling pod. Residual decontamination agent in the sampling pod is removed by a ventilation system. The robot arm is moved from inside the sampling pod to the sterile work space.

Description

[Technical field]

[0001] The present invention relates to a sterile work system in which a robot is used inside a chamber of a sterile work room such as an isolator. [Background technology]

[0002] It is important to maintain a sterile environment in pharmaceutical manufacturing sites. In particular, when decontaminating sterile work rooms used in pharmaceutical manufacturing, it is necessary to complete advanced decontamination validation in accordance with Good Manufacturing Practice (GMP).

[0003] For small-scale work in such a sterile environment, an isolator is used, which employs a small chamber as a work room and allows workers to work from outside the chamber through gloves or a half suit. The chamber of this isolator is equipped with a containment mechanism that maintains a sterile state to prevent contamination from the external environment. In addition, the sterile state is maintained even when necessary instruments and items are brought into the sterile isolator chamber from the external environment.

[0004] In recent years, robots have been used in isolators for work. For example, the following Patent Document 1 discloses a containment device for aseptically transferring powdered medicines filled in cans. Also, the following Patent Document 2 discloses a functional module for aseptically filling liquids into vials for medicines. In this way, it has been proposed to use a robot to efficiently fill containers such as vials for medicines with powders or liquids in a sterile state.

[0005] However, when changing the type of powder or liquid medicine handled during work, there is a risk that the previous medicine will adhere to the robot's arms or hands, making it necessary to decontaminate the inside of the isolator chamber and the robot again. Furthermore, when working with robots, there is a risk that the robot's arms or hands will generate dust during operation, so technology to improve the cleanliness performance of the robot itself is desired. One method to prevent dust generation from the robot itself is to attach a cover, but it is not easy to keep the cover airtight, and even if the surrounding area is decontaminated, there is a concern that air will leak from the non-decontaminated area inside the cover.

[0006] In addition, with the recent development of the field of regenerative medicine, it is becoming common to use incubators to culture cells. In regenerative medicine using cells, processes such as adjustment, culture, and processing of collected cells (cell processing) are required, and these processes are carried out in facilities called cell processing centers (CPCs). For example, the following Patent Document 3 discloses a cell culture processing system that can be used in combination with processing devices used in each process, improving sterility and efficiency. In this CPC, an isolator is used as a work room that requires the highest level of cleanliness, Grade A. In this case, the isolator and the incubator are connected in a sterile state, and the cells that have been adjusted are placed in the chamber of the incubator for culture.

[0007] In these operations, it is necessary to prevent the intrusion of foreign objects and dust, as well as germs, and maintain sterility. Furthermore, when culturing the patient's own cells (autologous culture), it is necessary to prevent contamination with other people's cells, other types of cells, non-autologous cells, and viruses and bacteria derived from those cells. Thus, when changing the cells being handled, there is a risk that the previous cells will adhere to the robot's arms or hands, and so it was necessary to decontaminate the inside of the isolator chamber and the robot again. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] Special Publication No. 2022-547842 [Patent Document 2] Special Publication No. 2023-534219 [Patent Document 3] JP 2012-147685 A Summary of the Invention [Problem to be solved by the invention]

[0009] Therefore, the present invention addresses the above-mentioned problems and aims to provide a sterile work system that can ensure the reliability of work in a sterile environment by confirming and recording the contamination status of specific parts of a robot arm that are likely to come into contact with powders, liquids, cells, etc. when working in a sterile environment, and the contamination status of foreign matter, dust, etc. generated from or attached to the specific parts of the robot arm, and by locally decontaminating or locally cleaning the specific parts of the robot arm when contamination is detected. [Means for solving the problem]

[0010] In order to solve the above problems, the inventors conducted extensive research and discovered that the above problems could be solved by focusing on specific parts of the hand and arm of the robot arm that come into contact with the object during sterile work, checking the contamination status of these parts, and decontaminating them when contamination is detected, which led to the completion of the present invention.

[0011] That is, the aseptic operation system according to the present invention comprises, according to claim 1: The present invention comprises a sterile work room capable of maintaining a sterile state, a robot equipped with a robot arm provided inside the sterile work room, a robot arm inspection device for detecting localized contamination of a predetermined portion of the robot arm, and a contamination removal device for removing the detected contaminant, the robot arm inspection device comprises a sampling pod that houses a predetermined portion of the robot arm, and a contamination detection device that detects dust generation and a contamination state from the predetermined portion of the robot arm, the contamination detection device comprising clean air supply means that supplies clean air to the predetermined portion of the robot arm, collection means that collects the supplied clean air, a particle counter that detects fine particles contained in the collected air, and a bioparticle counter that detects biological fine particles including microorganisms contained in the collected air, The decontamination apparatus has a decontamination mechanism, the decontamination mechanism including a decontamination agent supply device that supplies a decontamination agent into the sampling pod when performing a decontamination operation, and a ventilation device that removes the decontamination agent remaining in the sampling pod to maintain a sterile environment; a first movement operation of moving a predetermined portion of the robot arm into the sampling pod in a sterile work space inside the sterile work room at an intermediate stage of the sterile work by the robot or at a completion stage of the sterile work; a contamination detection operation of detecting dust generation from the predetermined portion of the robot arm after the movement and a contamination state due to the sterile work by the contamination detection device; a decontamination operation of decontaminating the predetermined portion of the robot arm in the sampling pod when contamination is detected; a ventilation operation of removing a decontamination agent remaining in the sampling pod after decontamination by the ventilation device; and a second movement operation of moving the predetermined portion of the robot arm from within the sampling pod to the sterile work space when contamination is not detected or after decontamination and ventilation, The method is characterized in that one or more cycles are carried out while maintaining the sterile condition inside the sterile work chamber.

[0012] According to claim 2, the present invention provides a sterile operation system according to claim 1, The decontamination mechanism of the decontamination device is characterized by including an ultrasonic vibration plate, which improves the efficiency of contamination detection and improves the decontamination efficiency of the decontamination operation.

[0013] According to claim 3, the present invention provides a sterile operation system according to claim 1, The decontamination equipment has a cleaning mechanism, which is equipped with a cleaning water supply device that supplies cleaning water when performing a cleaning operation with water, and a compressed air supply device that supplies compressed air when performing a cleaning operation with compressed air, and is characterized in that it performs a cleaning operation in addition to the decontamination operation.

[0014] According to claim 4, the present invention provides a sterile operation system according to claim 3, The cleaning mechanism of the contamination removal device is characterized by having an ultrasonic vibration plate, which improves the efficiency of contamination detection and the cleaning efficiency of the cleaning operation.

[0015] According to claim 5, the present invention provides a sterile operation system according to any one of claims 1 to 4, the sampling pod has an insertion port through which a predetermined portion of the robot arm is inserted into the sampling pod, and a closing means provided at the insertion port; The sealing means is in an open state when a specified part of the robot arm is inserted into the sampling pod, and after the specified part of the robot arm is inserted into the sampling pod, it adheres tightly to the outer periphery of the robot arm to seal the boundary between the inside of the sterile workroom and the inside of the sampling pod.

[0016] According to claim 6, the present invention provides a sterile operation system according to claim 5, The contamination detection device is equipped with one or more cameras, and the cameras are used to detect the status of the robot arm before and after the decontamination and cleaning operations. A given part It is characterized by its ability to check and record the state of surface contamination.

[0017] According to claim 7, the present invention provides a sterile operation system according to claim 5, The particle counter is characterized by having an alert function that automatically issues a warning when the number of detected particles exceeds a preset threshold.

[0018] According to claim 8, the present invention provides a sterile operation system according to claim 5, The bioparticle counter is characterized by having an alert function that automatically issues a warning when the number of detected biological particles exceeds a preset threshold value. Effect of the Invention

[0019] According to the above configuration, the aseptic work system of the present invention includes a sterile work room, a robot equipped with a robot arm, a robot arm inspection device, and a contamination removal device. The robot equipped with a robot arm and the robot arm inspection device are provided inside the aseptic work room. The robot arm inspection device includes a sampling pod that houses a predetermined part of the robot arm, and a contamination detection device that detects dust generation and a contamination state from the predetermined part of the robot arm. The contamination detection device includes clean air supply means, collection means, a particle counter, and a bioparticle counter.

[0020] The clean air supplying means supplies clean air to a predetermined portion of the robot arm. The collecting means collects the supplied clean air. The particle counter detects fine particles contained in the collected air. The biological particle counter detects biological fine particles including microorganisms contained in the collected air. The decontamination device also has a decontamination mechanism, which includes a decontamination agent supplying device that supplies a decontamination agent into the sampling pod when performing a decontamination operation, and a ventilation device that removes the decontamination agent remaining in the sampling pod to maintain a sterile environment.

[0021] The aseptic operation system according to the present invention comprises a first movement operation, a contamination detection operation, a decontamination operation, and a second movement operation, and these operations are performed in one cycle or multiple cycles while maintaining the aseptic state inside the aseptic operation room. The first movement operation is to move a predetermined part of the robot arm into a sampling pod in a sterile work space inside the aseptic work room during or at the end of the aseptic work by the robot. The contamination detection operation is to detect dust generation from a predetermined part of the robot arm after the movement and a contamination state due to the aseptic work by a contamination detection device. The decontamination operation is to decontaminate a predetermined part of the robot arm in the sampling pod when contamination is detected. The second movement operation is to move a predetermined part of the robot arm from inside the sampling pod to the aseptic work space when contamination is not detected or after decontamination and ventilation.

[0022] This makes it possible to provide a sterile work system that can ensure the reliability of work in a sterile environment by checking and recording the contamination status of specific parts of the robot arm that are likely to come into contact with powders, liquids, cells, etc. when working in a sterile environment, and the contamination status of foreign matter, dust, etc. that is generated from or adheres to the specific parts of the robot arm, and by locally decontaminating the specific parts of the robot arm when contamination is detected.

[0023] According to the above configuration, the decontamination mechanism of the decontamination device includes a cleaning water supply device that supplies cleaning water when a cleaning operation is performed, and a compressed air supply device that supplies compressed air when a cleaning operation using compressed air is performed, and thus a cleaning operation can be performed in addition to the decontamination operation. This makes it possible to more specifically and effectively exert the above-mentioned effects by performing local cleaning in addition to local decontamination.

[0024] The contamination removal device may also include an ultrasonic vibration plate. The ultrasonic vibration plate can improve the efficiency of contamination detection, the efficiency of decontamination in the decontamination operation, and the efficiency of cleaning in the cleaning operation. This makes it possible to more specifically and effectively achieve the above-mentioned effects.

[0025] Furthermore, according to the above configuration, the sampling pod has an insertion opening and a sealing means. The insertion opening is a portion through which a predetermined portion of the robot arm is inserted into the sampling pod, and is provided with a sealing means. The sealing means is in an open state when the predetermined portion of the robot arm is inserted into the sampling pod. On the other hand, after the predetermined portion of the robot arm is inserted into the sampling pod, the sealing means comes into close contact with the outer periphery of the robot arm to seal the boundary between the inside of the sterile work chamber and the inside of the sampling pod. This makes it possible to exert the above-mentioned operational effects more specifically and effectively.

[0026] According to the above configuration, the contamination detection device includes one or more cameras. The cameras capture images of the robot arm before and after the decontamination and cleaning operations. A given part The state of contamination on the surface is confirmed and recorded, which allows the above-mentioned effects to be exerted more specifically and effectively.

[0027] Furthermore, according to the above configuration, the bioparticle counter has an alert function that automatically issues a warning when the number of detected biological particles exceeds a preset threshold. Also, the particle counter has an alert function that automatically issues a warning when the number of detected particles exceeds a preset threshold. These features make it possible to more specifically and effectively exert the above-mentioned effects. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 is a front view showing aseptic work being performed by a robot arm inside a chamber of an isolator. [Diagram 2] FIG. 2 is a front view showing a state in which the contamination detection portion of the robot arm has been moved into the sampling pod in the front view of FIG. [Diagram 3] FIG. 3 is a plan view showing the interior of the chamber in the state shown in FIG. 2. [Figure 4] 1A is a perspective view showing a state in which an insertion opening of a sampling pod is open, and FIG. 1B is a perspective view showing a state in which the insertion opening is closed. [Diagram 5] 13 is a front view showing a state in which the contamination state of the robot arm inside the sampling pod is detected and a decontamination operation or cleaning operation can be performed. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The aseptic work system according to the present invention is used in the manufacture of pharmaceuticals and cell culture in regenerative medicine. The present invention is applied to cases where a sterile work room such as an isolator or RABS (restricted access barrier system) is used and an articulated robot is placed inside to perform unmanned work. The present invention will be described below with reference to an embodiment using an isolator.

[0030] Fig. 1 is a front view showing a state in which a robot arm is performing aseptic work inside the chamber of an isolator. In Fig. 1, a chamber 11 of an isolator body 10 is maintained in a grade A sterile state. The isolator body 10 is disposed inside a grade B or grade C clean room (not shown). The chamber 11 has two air blowers on the upper surface of a ceiling wall 12. machine A baffle plate 14 made of a mesh screen is provided below the ceiling wall 12. machine The air blown from 13 through HEPA filter 13a flows unidirectionally from top to bottom inside chamber 11 as laminar flow 15 of clean air, maintaining a clean environment inside the chamber. Note that the stand, drive unit, control unit, air supply and exhaust device, etc. of the isolator are omitted in Figure 1.

[0031] Inside the chamber 11, an articulated robot 20 (center in the figure) and a sampling pod 30 (left side in the figure) are arranged on the bottom wall surface 16. The articulated robot 20 is composed of a robot body 21 and a robot arm 22 equipped with a robot hand. The robot arm 22 is composed of a robot hand 22a, a first robot arm 22b, and a second robot arm 22c. In the present invention, a predetermined portion of the first robot arm 22b equipped with the robot hand 22a is used as a local contamination detection portion. In addition, a sterile work space 23 (a dashed area in front of the robot in the figure) where the articulated robot 20 performs sterile work is provided on the bottom wall surface 16 of the chamber 11, and in FIG. 1, the articulated robot 20 performs sterile work using the robot arm 22.

[0032] The sampling pod 30 has a ULPA filter on the ceiling. - A blower 31 is installed at the top and a decontamination agent decomposition filter is installed on the side wall. - A ventilation device 32 equipped with a ventilation mechanism is provided. A contamination detection device X, a decontamination mechanism Y, and a cleaning mechanism Z are connected to the sampling pod 30 (the details of each device will be described later).

[0033] Here, each operation of the aseptic operation system according to this embodiment will be specifically described. In aseptic operation in a sterile environment, the inside of the chamber 11 and the articulated robot 20 and sampling pod 30 arranged therein are decontaminated before the operation, and then the aseptic operation is performed while maintaining the aseptic environment. In the aseptic operation state shown in FIG. 1, the tip of the robot arm 22 is located at the position of the aseptic work space 23. This aseptic work space 23 is also called the critical area, and is the most important aseptic area inside the grade A chamber 11. In aseptic operation, for example, cell culture in regenerative medicine, petri dishes, vials, rubber stoppers, cultured cells, etc. are operated by the robot hand 22a in the aseptic work space 23. Note that during aseptic operation, particles are constantly monitored in the critical area by a separate particle counter (not shown).

[0034] During this aseptic work, there is a risk that the cultured cells and microorganisms attached thereto may come into contact with, scatter, and adhere to parts of the robot hand 22a or the first robot arm 22b. In addition, when the articulated robot 20 is used, there is a risk of dust being generated from joints during operation. If cultured cells or instruments of another lot are operated in this contaminated state, contamination with dust, cells, microorganisms, etc. will occur. Therefore, in principle, when there is a risk of contamination, such as when a different lot is being handled, it is necessary to clean and decontaminate the inside of the chamber 11 and the articulated robot 20 arranged therein again. However, this is very difficult in reality.

[0035] Therefore, in the present invention, attention is focused on a part of the robot hand 22a or the first robot arm 22b (hereinafter referred to as "a predetermined part of the robot arm 22") that is at high risk of contamination. Then, during the middle stage of the aseptic work by the articulated robot 20 or at the end stage of the aseptic work, the contamination state of the predetermined part of the robot arm 22 is detected by the contamination detection device X. In this way, while maintaining the aseptic environment inside the chamber 11, the contamination state can be confirmed without interrupting the aseptic work for a long period of time, and when contamination is detected, the predetermined part of the robot arm 22 is decontaminated or cleaned.

[0036] In the aseptic operation system according to the present invention, the first moving operation, the contamination detection operation, the decontamination operation, the ventilation operation, the cleaning operation, and the second moving operation are performed in combination as necessary. Moreover, these operations can be performed in one cycle or multiple cycles while maintaining the aseptic state inside the chamber 11. Each operation will be described below.

[0037] ≪First movement operation≫ The first moving operation is to move a predetermined part of the robot arm 22 into the sampling pod 30 in the middle of the aseptic work by the articulated robot 20 or at the end of the aseptic work in the aseptic work space 23 inside the chamber 11. FIG. 2 is a front view showing a state in which the contamination detection part of the robot arm has been moved into the sampling pod in the front view of FIG. 1. FIG. 3 is a plan view showing the state inside the chamber in the state of FIG. 2. In FIGS. 2 and 3, the robot arm 22 of the articulated robot 20 has its tip part (robot hand 22a and a part of the first robot arm 22b) inserted inside the sampling pod 30. This part is a local contamination detection target (a predetermined part of the robot arm 22) with the highest contamination risk in the aseptic work.

[0038] To detect contamination of a predetermined portion of the robot arm 22 and to locally decontaminate it, it is necessary to seal off the inside of the sampling pod 30 into which the predetermined portion of the robot arm 22 is inserted, to prevent communication with the inside of the chamber 11. If this is not done properly, it will be impossible to sample appropriate test air (described later) from the contamination detection target, and during decontamination, the decontamination agent will leak from the inside of the sampling pod 30 into the inside of the chamber 11. Therefore, a mechanism is provided on the side wall of the sampling pod 30 that seals off the inside of the sampling pod 30 by coming into close contact with the outer periphery of the arm of the robot arm 22.

[0039] 4A and 4B are perspective views showing a state in which the insertion opening of the sampling pod is open and closed, respectively. In FIG. 4A, an insertion opening 34 is open on one side surface 33 of the sampling pod 30. The other three sides are closed by side walls. The insertion opening 34 is provided with shutters 33a and 33b that open and close in the vertical direction, and approximately semicircular openings 34a and 34b are provided in the center of each of the shutters 33a and 33b, which are large enough to cover and contact the outer periphery of the arm of the robot arm 22. As a result, after the robot arm 22 is inserted, the shutters 33a and 33b are closed from the vertical direction by the drive of a shutter closing device (not shown) to seal the inside of the sampling pod 30.

[0040] Fig. 4(B) shows a state in which the insertion opening 34 is closed. In Fig. 4(B), on the side surface 33 of the sampling pod 30, the shutters 33a, 33b closed from above and below are in close contact with the arm portion of the first robot arm 22b and seal the inside of the sampling pod 30. The material of the shutters 33a, 33b and the material of the abutting portion of the shutters 33a, 33b and the material of the approximately semicircular openings 34a, 34b are not particularly limited, but are preferably flexible and resistant to the decontamination agent. sex In this embodiment, a flexible epoxy resin sheet is used. In this manner, a predetermined portion of the robot arm 22 to be decontaminated is inserted into the sampling pod 30, and contamination detection of the predetermined portion of the robot arm 22 is performed with the side surface 33 sealed.

[0041] <Contamination detection operation> In the contamination detection operation, the contamination state of a predetermined portion of the robot arm 22 is detected by the contamination detection device X. Fig. 5 is a front view showing a state in which the contamination state of the robot arm is detected inside the sampling pod and a decontamination operation or a cleaning operation can be performed. In Fig. 5, the sampling pod 30 has one air blower on the upper surface of the ceiling wall 35. machine A flow plate 36 made of a screen mesh is provided below the ceiling wall 35 of the sampling pod 30.

[0042] The pollution detection device X is a blower machine The robot arm 22 is provided with a clean air supply device 41 that supplies clean air to a predetermined portion of the robot arm 22 as the pollution collecting air 37 via the air supply pipe 41a. machine The pollution collecting air 37 supplied to 31 is blown machine Air is sent from 31 through a ULPA filter 31a (in some cases, a HEPA filter can also be used) into the inside of the sampling pod 30, and is blown onto a predetermined part of the robot arm 22 as contamination capturing air 37 that flows unidirectionally from top to bottom. Here, if the predetermined part of the robot arm 22 is contaminated, contaminants are captured in this air.

[0043] Air that may have trapped contaminants (sample air) flows in a one-way direction from top to bottom and is collected by collector 45b of particle counter 45 and collector 46b of bioparticle counter 46 below sampling pod 30. The sample air collected by collectors 45b and 46b is sent to particle counter 45 and bioparticle counter 46 via collection pipes 45a and 46a, respectively, and the state of contamination is detected.

[0044] Since the pollution trapping air 37 flows in one direction, it is preferable to move and rotate the first robot arm 22b in the forward and backward directions so that the pollution trapping air 37 is blown uniformly over the entire predetermined portion of the robot arm 22 (see the arrows attached to the first robot arm 22b in FIG. 5). machine It is preferable that the wind speed and volume of the contamination collecting air blown from 31 be variable and appropriately adjusted depending on the capacity of the sampling pod 30, the volume of a predetermined portion of the robot arm 22, the collecting capacity of the collectors 45b and 46b, and the like.

[0045] In addition, ventilation machine 5 may be supplied as contamination collecting air 37 to a predetermined portion of the robot arm 22 via 31, and compressed air may be discharged (continuously or intermittently) as contamination collecting air from a compressed air supply device 44 shown in Fig. 5 via a discharger (not shown) connected to the tip of the supply piping 44a onto the surface of a predetermined portion of the robot arm 22 within the sampling pod 30. The shape and number of the dischargers are not particularly limited, but it is preferable that they have a structure for discharging uniformly onto the surface of the robot arm 22 and that they are arranged at multiple locations.

[0046] In addition, when capturing pollutants with the pollution capturing air 37, the efficiency of capturing pollutants can be improved by operating the ultrasonic vibration plate 47 shown in FIG. 5 to apply ultrasonic vibration and acoustic radiation pressure from the plate surface.

[0047] Here, the particle counter 45 and the bioparticle counter 46 that work together as the contamination detection device X will be described. The particle counter 45 is also called a particle measuring device, and is a measuring device that counts dust, particles, impurities, etc. in the air. The sample air collected by the collector 45b from a predetermined part of the robot arm 22 inside the sampling pod 30 is sent to the particle counter 45 via the collection pipe 45a, and the sample air is irradiated with laser light to measure the size and number of particles from the light scattering intensity. In the present invention, the size and number of particles are measured, which is a sum of particles generated from joints and the like due to the operation of the robot arm 22 of the articulated robot 20 (hereinafter referred to as "non-biological particles") and cells and microorganisms attached to the robot arm 22 during aseptic work (hereinafter referred to as "biological particles").

[0048] On the other hand, the bioparticle counter 46 is also called an airborne bacteria counter, and is a measuring instrument that counts airborne bacteria contained in dust and fine particles in the air, similar to the particle counter 45. In particular, it is preferable to adopt a bioparticle counter used in the rapid microorganism measurement method (RMM). The sample air collected by the collector 46b from a predetermined part of the robot arm 22 inside the sampling pod 30 is sent to the bioparticle counter 46 via the collection pipe 46a, and the sample air is irradiated with laser-induced fluorescence (LIF) to detect the spontaneous luminescence due to the constituents of the airborne bacteria, thereby measuring the size and number of the airborne bacteria. In the present invention, the size and number of biological particles attached to the robot arm 22 during aseptic work are particularly measured.

[0049] Furthermore, the contamination detection device X may be equipped with one or more cameras 48 (see FIG. 5). These cameras photograph the surface of a predetermined portion of the robot arm 22 after the decontamination operation, and confirm that no coarse particles or contaminants that cannot be detected by the particle counter 45 or bioparticle counter 46 are attached to the robot arm 22. Note that images may also be taken before the contamination detection operation, after the decontamination operation, and after the cleaning operation, to confirm and record the contamination state of the surface of the robot arm 22 before and after the decontamination and cleaning operations.

[0050] Furthermore, the contamination detection device X may be provided with an alert function that automatically issues a warning when contamination is detected by the particle counter 45 or the bioparticle counter 46. Specifically, it is preferable to set the alert function to automatically issue a warning when the number of particles or biological particles detected by the particle counter 45 or the bioparticle counter 46 exceeds a preset threshold value.

[0051] In the above-mentioned contamination detection operation, if microparticles or biological microparticles are detected by the particle counter 45 or the bioparticle counter 46, the next decontamination operation or cleaning operation is performed. If microparticles or biological microparticles are not detected, the decontamination operation or cleaning operation is not performed and the process proceeds to the second movement operation described below.

[0052] <Decontamination operations> The decontamination operation is performed when a contaminant is detected from a predetermined part of the robot arm 22 in the contamination detection operation. In particular, the decontamination operation must be performed when biological particles are detected by the bioparticle counter 46. The decontamination operation decontaminates only a predetermined part of the robot arm 22 inside the sampling pod 30. In the contamination detection operation, a predetermined part of the robot arm 22 to be decontaminated is inserted into the sampling pod 30, and the side 33 of the sampling pod 30 is sealed (FIG. 4(B)). The blower 31 of the sampling pod 30 is stopped. In this state, the decontamination agent supply device 42 of the decontamination mechanism Y supplies the decontamination agent stored inside as gas or mist to the inside of the sampling pod 30 through the supply pipe 42a and a discharger (not shown) connected to the tip of the supply pipe 42a.

[0053] In this embodiment, hydrogen peroxide is used as the decontamination agent, but the decontamination agent is not limited to this and may be a disinfectant such as peracetic acid, formaldehyde, or alcohol. Hydrogen peroxide may be heated with a heating plate or the like and supplied as hydrogen peroxide gas, or may be supplied as mist with a two-fluid nozzle or ultrasonic atomizer. In this embodiment, hydrogen peroxide and compressed air are supplied as mist to the sampling pod 30 using a two-fluid nozzle (not shown) and decontaminated for a predetermined time.

[0054] In addition, when decontaminating a specific portion of the robot arm 22, the ultrasonic vibration plate 47 shown in FIG. 5 is operated to apply ultrasonic vibration and acoustic radiation pressure from the plate surface, thereby improving the efficiency of decontamination using decontamination agent gas or mist.

[0055] <Ventilation operation> When the decontamination operation for a predetermined period of time is completed, a ventilation operation is performed. In the ventilation operation, the decontamination agent remaining in the sampling pod 30 after decontamination is removed by the ventilation device 32. First, aeration is performed to release the remaining hydrogen peroxide from inside the sampling pod 30. In aeration, clean air is released from the blower 31 of the sampling pod 30 into the inside of the sampling pod 30, and the hydrogen peroxide is decomposed and removed by the ventilation device 32 equipped with a decomposition filter 32a.

[0056] When the decontamination and ventilation operations are completed, the contamination detection operation may be performed again to confirm the effectiveness of the decontamination. If the effectiveness of the decontamination is confirmed, proceed to the second moving operation described below. However, even if no biological particles are confirmed in the contamination detection operation, if non-biological particles are confirmed, the next cleaning operation is performed.

[0057] <Cleaning Operation> The cleaning operation is performed when contaminants (only non-biological particles) are detected from a predetermined part of the robot arm 22 in the contamination detection operation. In particular, it must be performed when no biological particles are detected by the bioparticle counter 46, and non-biological particles (the number obtained by subtracting the number of biological particles from the total number of particles) are detected by the particle counter 45. The cleaning operation is performed by cleaning only a predetermined part of the robot arm 22 inside the sampling pod 30. In this embodiment, the cleaning operation includes water cleaning with cleaning water and air cleaning with compressed air.

[0058] First, in the water washing with washing water, a predetermined part of the robot arm 22 to be decontaminated is inserted inside the sampling pod 30, and the side surface 33 of the sampling pod 30 is sealed (FIG. 4(B)). The blower 31 of the sampling pod 30 is stopped. In this state, the washing water supply device 43 of the washing mechanism Z supplies washing water to the inside of the sampling pod 30 through the supply pipe 43a and a discharger (not shown) connected to the tip of the supply pipe 43a. The washing water after washing is discharged outside the system from an exhaust port (not shown) provided at the bottom of the sampling pod 30. The predetermined part of the robot arm 22 after washing may be dried with clean air blown from the blower 31 of the sampling pod 30.

[0059] On the other hand, in air cleaning with compressed air, compressed air may be discharged (continuously or intermittently) from the compressed air supply device 44 of the cleaning mechanism Z as air cleaning air via a discharger (not shown) connected to the tip of the supply pipe 44a onto the surface of a predetermined part of the robot arm 22 inside the sampling pod 30. The shape and number of the dischargers are not particularly limited, but it is preferable that they have a structure for discharging air evenly onto the surface of the robot arm 22 and that they are arranged in multiple locations.

[0060] Once the cleaning operation is complete, the contamination detection operation may be performed again to confirm the effectiveness of the decontamination. If the effectiveness of the decontamination is confirmed, proceed to the second moving operation described below. However, if non-biological particles are confirmed in the contamination detection operation, the cleaning operation is performed again.

[0061] ≪Second movement operation≫ In the second movement operation, after the contamination detection operation is completed, a predetermined part of the robot arm 22 that has been confirmed to be clean and free of contamination is removed from the inside of the sampling pod 30 by opening the shutters 33a, 33b, and moved to the sterile work space 23. This allows the next sterile operation to be performed without having to decontaminate or clean the inside of the chamber 11 and the articulated robot 20 and other parts arranged therein. In this way, it is possible to perform the next sterile operation without having to decontaminate or clean the inside of the chamber 11 every time the object of the sterile operation is changed. This series of operations may be automatically operated under the control of a microcomputer.

[0062] As explained above, according to the present invention, the contamination status of specific parts of a robot arm that are likely to come into contact with powder, liquid, cells, etc. when working in a sterile environment, and the contamination status of foreign matter, dust, etc. generated from or attached to the specific part of the robot arm are confirmed and recorded, and when contamination is detected, the specific part of the robot arm is locally decontaminated, thereby ensuring the reliability of work in a sterile environment. [Explanation of symbols]

[0063] 10: isolator body, 11: chamber, 12: ceiling wall, 13...Ventilator machine , 13a...HEPA filter, 14...rectifier plate, 15...Laminar flow, 16...Bottom wall, 20... Articulated robot, 21... Robot body, 22... Robot arm, 22a...robot hand, 22b...first robot arm, 22c...second robot arm, 23...Sterile work space (critical area), 30...sampling pod, 31...blower, 32...ventilation device, 32a...decomposition filter, 33... side surface, 33a, 33b... shutter, 34... insertion port, 34a, 34b... opening, 35...ceiling wall, 36...rectifier plate, 37...contamination collecting air, 41: clean air supply device, 41a: supply piping, 42: decontamination agent supply device, 42a: supply piping, 43... cleaning water supply device, 43a... supply piping, 44... compressed air supply device, 44a... supply piping, 45: Particle counter, 45a: Collection pipe, 46...Bio particle counter, 46a...Collection piping, X...contamination detection device, Y...decontamination mechanism, Z...cleaning mechanism.

Claims

1. The present invention comprises a sterile work room capable of maintaining a sterile state, a robot equipped with a robot arm provided inside the sterile work room, a robot arm inspection device for detecting localized contamination of a predetermined portion of the robot arm, and a contamination removal device for removing the detected contaminant, the robot arm inspection device comprises a sampling pod that houses a predetermined portion of the robot arm, and a contamination detection device that detects dust generation and a contamination state from the predetermined portion of the robot arm, the contamination detection device comprising clean air supply means that supplies clean air to the predetermined portion of the robot arm, collection means that collects the supplied clean air, a particle counter that detects fine particles contained in the collected air, and a bioparticle counter that detects biological fine particles including microorganisms contained in the collected air, The decontamination device has a decontamination mechanism, the decontamination mechanism including a decontamination agent supply device that supplies a decontamination agent into the sampling pod during operation, and a ventilation device that removes the decontamination agent remaining in the sampling pod to maintain a sterile environment; a first movement operation of moving a predetermined portion of the robot arm into the sampling pod in a sterile work space inside the sterile work room at an intermediate stage of the sterile work by the robot or at a completion stage of the sterile work; a contamination detection operation of detecting dust generation from the predetermined portion of the robot arm after the movement and a contamination state due to the sterile work by the contamination detection device; a decontamination operation of decontaminating the predetermined portion of the robot arm in the sampling pod when contamination is detected; a ventilation operation of removing a decontamination agent remaining in the sampling pod after decontamination by the ventilation device; and a second movement operation of moving the predetermined portion of the robot arm from within the sampling pod to the sterile work space when contamination is not detected or after decontamination and ventilation. A sterile work system characterized by performing one or more cycles while maintaining the sterile condition inside the sterile work room.

2. 2. The aseptic operation system according to claim 1, wherein the decontamination mechanism of the decontamination device includes an ultrasonic vibration plate for improving the efficiency of contamination detection and the efficiency of decontamination by the decontamination operation.

3. 2. The aseptic operation system according to claim 1, wherein the decontamination device has a cleaning mechanism, the cleaning mechanism comprising a cleaning water supply device for supplying cleaning water when performing a cleaning operation with water, and a compressed air supply device for supplying compressed air when performing a cleaning operation with compressed air, and wherein the cleaning operation is performed in addition to the decontamination operation.

4. 4. The aseptic operation system according to claim 3, wherein the cleaning mechanism of the contamination removal device includes an ultrasonic vibration plate for improving the efficiency of contamination detection and the cleaning efficiency of the cleaning operation.

5. the sampling pod has an insertion port through which a predetermined portion of the robot arm is inserted into the sampling pod, and a closing means provided at the insertion port; A sterile work system as described in any one of claims 1 to 4, characterized in that the sealing means is in an released state when a specified part of the robot arm is inserted into the sampling pod, and after the specified part of the robot arm is inserted into the sampling pod, it adheres tightly to the outer periphery of the robot arm to seal off the boundary between the inside of the sterile work room and the inside of the sampling pod.

6. The aseptic work system according to claim 5, characterized in that the contamination detection device is equipped with one or more cameras, and the cameras are used to confirm and record the contamination state of the surface of a specified part of the robot arm before and after the decontamination operation.

7. 6. The aseptic work system according to claim 5, wherein the particle counter has an alert function that automatically issues a warning when the number of detected particles exceeds a preset threshold value.

8. 6. The aseptic work system according to claim 5, wherein the bioparticle counter has an alert function that automatically issues a warning when the number of detected biological particles exceeds a preset threshold value.

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