Aseptic work system

Abstract

This system provides a sterile work system that ensures the reliability of work in a sterile environment by confirming and recording the contamination status of designated parts of a robot arm that are likely to come into contact with powders, liquids, cells, etc., during work in a sterile environment, as well as the contamination status of foreign matter, dust, etc. generated or attached to those designated parts of the robot arm, and by performing local decontamination or local cleaning of the designated parts of the robot arm when contamination is detected. [Solution] A robot and a robotic arm inspection device are installed inside a sterile workroom. The robotic arm is moved into a sampling pod during or after the sterile work. Dust generation and contamination status from the robotic arm are detected by a contamination detection device. The robotic arm is decontaminated inside the sampling pod. Any remaining decontamination agent inside the sampling pod is removed by a ventilation device. The robotic arm is moved from inside the sampling pod to the sterile work space.

Description

Technical Field

[0001] The present invention relates to an aseptic work system when using a robot inside a chamber of an aseptic workroom such as an isolator.

Background Art

[0002] In a manufacturing site for manufacturing pharmaceuticals and the like, it is important to maintain an aseptic state indoors. Particularly, in the decontamination of an aseptic workroom which is a workroom for pharmaceutical manufacturing, it is necessary to complete a high-level decontamination validation in accordance with GMP (Good Manufacturing Practice).

[0003] In such small-scale work in an aseptic environment, an isolator is used which employs a small chamber as a workroom and allows an operator to work from the outside of the chamber through gloves or a half suit. The chamber of this isolator is provided with a containment mechanism for maintaining an aseptic state so that contaminants do not mix in from the external environment. Also, when carrying in necessary instruments and articles from the external environment into the chamber of the aseptic isolator, the maintenance of the aseptic state is achieved.

[0004] In recent years, work using a robot has been carried out in an isolator. For example, in Patent Document 1 below, a containment device for aseptically transferring a powdered pharmaceutical filled in a can is disclosed. Also, in Patent Document 2 below, a functional module for aseptically filling a liquid into a vial for pharmaceuticals is disclosed. Thus, proposals have been made to efficiently perform the work of aseptically filling powders and liquids into containers such as vials for pharmaceuticals in an aseptic state by using a robot.

[0005] However, when changing the type of powdered or liquid pharmaceuticals being handled during operation, there is a risk that the previous pharmaceuticals may adhere to the robot's arms or hands, requiring the inside of the isolator chamber and the robot itself to be decontaminated again. Furthermore, robotic operations carry the risk of dust generation from the robot's arms and hands during operation, and technologies to improve the cleanliness of the robot itself are desired. One method to prevent dust generation from the robot itself is to attach a cover, but maintaining airtightness of the cover itself is not easy, and even if the surrounding area is decontaminated, there is a concern that air may leak from the undecontaminated area inside the cover.

[0006] Furthermore, with the recent advancements in the field of regenerative medicine, the use of incubators to culture cells has become widespread. Cell-based regenerative medicine requires processes such as preparation, culture, and processing of collected cells (cell processing), which are carried out in facilities called cell processing centers (CPCs). For example, Patent Document 3 below discloses a cell culture processing system that can be used in combination with the processing equipment used in each process, thereby improving sterility and efficiency. In this CPC, an isolator is used as a workspace requiring the highest level of cleanliness, Grade A. In this case, the isolator and the incubator are connected in a sterile state, and the prepared cells are placed in the incubator chamber for culture.

[0007] In these operations, it is necessary to prevent the intrusion of foreign matter and dust, as well as bacteria, and to maintain sterility. Furthermore, when culturing the patient's own cells (autologous culture), it is necessary to prevent contamination by cells from other people, other species, non-autologous cells, viruses, bacteria derived from those cells, etc. Thus, when changing the cells being handled, there is a risk that the previous cells may adhere to the robot's arms or hands, and 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] Japanese Patent Publication No. 2012-147685 [Overview of the project] [Problems that the invention aims to solve]

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

[0010] In order to solve the above problems, the inventors of the present invention, through diligent research, focused on the hand and arm of a robot arm that comes into contact with an object during sterile work, and found that the above problems could be solved by checking the contamination status of this part and decontaminating it when contamination was detected, thus completing the present invention.

[0011] In other words, according to the description in claim 1, the sterile work system according to the present invention is: The system comprises a sterile workroom capable of maintaining a sterile state, a robot equipped with a robotic arm installed inside the sterile workroom, a robotic arm inspection device that locally detects contamination in a predetermined portion of the robotic arm, and a contamination removal device that removes the detected contaminants. The robot arm inspection apparatus comprises a sampling pod that houses a predetermined portion of the robot arm, and a contamination detection device that detects dust generation and contamination status from the predetermined portion of the robot arm, the contamination detection device comprising a clean air supply means that supplies clean air to the predetermined portion of the robot arm, a 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 bio-particles containing microorganisms contained in the collected air. The decontamination device has a decontamination mechanism, which includes 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. In the sterile work space inside the sterile workroom, at an intermediate stage or completion stage of the sterile work performed by the robot, a first movement operation is performed to move a predetermined portion of the robot arm into the sampling pod; a contamination detection operation is performed to detect dust generation from the predetermined portion of the robot arm after movement and the contamination state due to the sterile work using the contamination detection device; a decontamination operation is performed to decontaminate the predetermined portion of the robot arm inside the sampling pod when contamination is detected; a ventilation operation is performed to remove any remaining decontamination agent inside the sampling pod using the ventilation device after decontamination; and a second movement operation is performed to move a predetermined portion of the robot arm from inside the sampling pod to the sterile work space when contamination is not detected or after decontamination and ventilation. The method is characterized by performing one or more cycles while maintaining the sterile condition inside the sterile workroom.

[0012] Furthermore, according to the description in claim 2, the present invention is a sterile work system as described in claim 1, The decontamination mechanism of the aforementioned contamination removal device is equipped with an ultrasonic vibrator, and is characterized by improving the contamination detection efficiency and the decontamination efficiency through the decontamination operation.

[0013] Furthermore, according to claim 3, the present invention is a sterile work system as described in claim 1, The decontamination device has a cleaning mechanism, which includes 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 by performing a cleaning operation in addition to the decontamination operation.

[0014] Furthermore, according to claim 4, the present invention is a sterile work system as described in claim 3, The cleaning mechanism of the aforementioned contamination removal device is equipped with an ultrasonic vibrator, and is characterized by improving contamination detection efficiency and cleaning efficiency through the cleaning operation.

[0015] Furthermore, according to claim 5, the present invention is a sterile work system according to any one of claims 1 to 4, The sampling pod has an insertion port into which a predetermined portion of the robot arm is inserted, and a sealing means provided at the insertion port. The sealing means is in an open state when a predetermined portion of the robot arm is inserted into the sampling pod, and after the predetermined portion of the robot arm is inserted into the sampling pod, it adheres tightly to the outer circumference of the robot arm to seal the boundary between the inside of the sterile work chamber and the inside of the sampling pod.

[0016] Furthermore, according to the description in claim 6, the present invention is a sterile work system as described in claim 5, The contamination detection device is equipped with one or more cameras, and is characterized by using these cameras to confirm and record the contamination status of the surface of the robot arm before and after decontamination and cleaning operations.

[0017] Furthermore, according to claim 7, the present invention is a sterile work system as described in 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] Also, according to the description of claim 8, the present invention provides a sterile working system as described in claim 5, wherein the bio-particle counter is characterized by having an alert function that automatically issues a warning when the number of detected viable particles exceeds a preset threshold value.

Advantages of the Invention

[0019] According to the above configuration, the sterile working system according to the present invention includes a sterile working chamber, a robot equipped with a robotic arm, a robotic arm inspection device, and a contamination removal device. The robot equipped with the robotic arm and the robotic arm inspection device are provided inside the sterile working chamber. The robotic arm inspection device includes a sampling pod for accommodating a predetermined portion of the robotic arm, and a contamination detection device for detecting the dust generation and contamination state from the predetermined portion of the robotic arm. The contamination detection device includes a clean air supply means, a collection means, a particle counter, and a bio-particle counter.

[0020] The clean air supply means supplies clean air to a predetermined portion of the robotic arm. The collection means collects the supplied clean air. The particle counter detects the particles contained in the collected air. The bio-particle counter detects viable particles including microorganisms contained in the collected air. Further, the contamination removal device has a decontamination mechanism, and the decontamination mechanism includes a decontamination agent supply device for supplying a decontamination agent into the sampling pod when performing a decontamination operation, and a ventilation device for removing the decontamination agent remaining in the sampling pod to maintain a sterile environment.

[0021] Furthermore, the sterile work system according to the present invention consists of a first movement operation, a contamination detection operation, a decontamination operation, and a second movement operation, and these operations are performed in one or more cycles while maintaining a sterile state inside the sterile workroom. The first movement operation moves a predetermined part of the robot arm into the sampling pod in the sterile work space inside the sterile workroom, either at an intermediate stage of the sterile work performed by the robot or at the end of the sterile work. The contamination detection operation detects dust generation from the predetermined part of the robot arm after movement and the contamination state due to the sterile work using a contamination detection device. The decontamination operation decontaminates the predetermined part of the robot arm inside the sampling pod when contamination is detected. The second movement operation moves the predetermined part of the robot arm from inside the sampling pod to the sterile work space when contamination is not detected or after decontamination and ventilation.

[0022] This enables the provision of a sterile work system that ensures the reliability of work in a sterile environment by confirming and recording the contamination status of a predetermined part of the robot arm that is likely to come into contact with powders, liquids, cells, etc. during work in a sterile environment, as well as the contamination status of foreign matter, dust, etc. generated or attached to that predetermined part of the robot arm, and by locally decontaminating the predetermined part of the robot arm when contamination is detected.

[0023] Furthermore, according to the above configuration, the decontamination mechanism of the decontamination device includes a washing water supply device that supplies washing water when performing a washing operation, and a compressed air supply device that supplies compressed air when performing a washing operation using compressed air, allowing for washing operations in addition to the decontamination operation. As a result, the above effects can be exerted more concretely and effectively by performing local washing in addition to local decontamination.

[0024] Furthermore, the decontamination device may be equipped with an ultrasonic vibrator. The ultrasonic vibrator can improve the detection efficiency of contamination detection, the decontamination efficiency of decontamination operations, and the cleaning efficiency of cleaning operations. This allows the above effects to be achieved more concretely and effectively.

[0025] Furthermore, according to the above configuration, the sampling pod has an insertion port and a sealing means. The insertion port is the portion into which a predetermined part of the robot arm is inserted into the sampling pod, and a sealing means is provided therein. The sealing means is in an open state when the predetermined part of the robot arm is inserted into the sampling pod. On the other hand, after the predetermined part of the robot arm is inserted into the sampling pod, the sealing means adheres tightly to the outer circumference of the robot arm, sealing 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 effects more concretely and effectively.

[0026] Furthermore, according to the above configuration, the contamination detection device is equipped with one or more cameras. The cameras confirm and record the contamination status of the robot arm surface before and after decontamination and cleaning operations. This allows the above effects to be demonstrated more concretely and effectively.

[0027] Furthermore, with the above configuration, the bioparticle counter is equipped with an alert function that automatically issues a warning when the number of detected bioparticles exceeds a preset threshold. These features allow the above effects to be achieved more concretely and effectively. [Brief explanation of the drawing]

[0028] [Figure 1] This is a front view showing a robotic arm performing sterile work inside the isolator chamber. [Figure 2] Figure 1 is a front view showing the contamination detection portion of the robot arm moved into the sampling pod. [Figure 3] This is a plan view showing the internal state of the chamber in the state shown in Figure 2. [Figure 4] This is a perspective view showing the sampling pod in two states: (A) with the insertion port open, and (B) with the insertion port closed. [Figure 5] This is a front view showing the state in which the contamination status of the robotic arm inside the sampling pod is detected, and decontamination or cleaning operations can be performed. [Modes for carrying out the invention]

[0029] The sterile work system according to the present invention is used in the manufacture of pharmaceuticals and in cell culture in regenerative medicine. This invention applies to cases where a sterile workroom, such as an isolator or RABS (Access Restriction 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] Figure 1 is a front view showing a robotic arm performing sterile work inside the chamber of an isolator. In Figure 1, the chamber 11 of the isolator body 10 is maintained in a Grade A sterile state. The isolator body 10 is installed inside a Grade B or Grade C cleanroom (not shown). Two blowers 13 are positioned on the upper surface of the ceiling wall 12 of the chamber 11. Below the ceiling wall 12, a rectifier plate 14 made of screen mesh is provided. The air blown from the blowers 13 through the HEPA filter 13a flows as a unidirectional laminar flow 15 of clean air flowing from top to bottom inside the chamber 11, maintaining a clean environment inside the chamber. Note that the isolator stand, drive unit, control unit, and air supply and exhaust system are omitted in Figure 1.

[0031] Furthermore, a multi-joint robot 20 (center in the figure) and a sampling pod 30 (left in the figure) are positioned on the bottom wall surface 16 of the chamber 11. The multi-joint robot 20 consists of a robot body 21 and a robot arm 22 equipped with a robot hand. The robot arm 22 consists of a robot hand 22a, a first robot arm 22b, and a second robot arm 22c. In this invention, a predetermined portion of the first robot arm 22b equipped with the robot hand 22a is designated as a local contamination detection area. In addition, a sterile work space 23 (dashed line area in front of the robot in the figure) is provided on the bottom wall surface 16 of the chamber 11 where the multi-joint robot 20 performs sterile work, and in Figure 1, the multi-joint robot 20 is performing sterile work with the robot arm 22.

[0032] The sampling pod 30 is equipped with a blower 31 on the ceiling with a ULPA filter (not shown) on top, and a ventilation device 32 on the side wall with a decontamination agent decomposition filter (not shown). The sampling pod 30 is also connected to a contamination detection device X, a decontamination mechanism Y, and a cleaning mechanism Z (details of each device will be described later).

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

[0034] During this sterile operation, there is a risk that cultured cells and microorganisms attached to them may come into contact with and be scattered onto parts of the robot hand 22a or the first robot arm 22b. Furthermore, if the articulated robot 20 is used, there is a risk of dust generation from its joints during operation. Handling cultured cells or instruments from other lots in this contaminated state will result in contamination by dust, cells, and microorganisms. Therefore, ideally, if there is a risk of contamination, such as when handling different lots, the inside of the chamber 11 and the articulated robot 20 placed inside should be cleaned and decontaminated again. However, this is practically very difficult.

[0035] Therefore, in this invention, we focused on a portion of the robot hand 22a and the first robot arm 22b (hereinafter referred to as "a predetermined portion of the robot arm 22"), which have a high risk of contamination. The contamination status of the predetermined portion of the robot arm 22 is detected by the contamination detection device X during or after the sterile work performed by the articulated robot 20. This allows the contamination status to be checked without interrupting the sterile work for a long time while maintaining the sterile environment inside the chamber 11, and when contamination is detected, the predetermined portion of the robot arm 22 is decontaminated or cleaned.

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

[0037] ≪First movement operation≫ The first movement operation involves moving a predetermined portion of the robot arm 22 into the sampling pod 30 at an intermediate stage or completion stage of aseptic work performed by the articulated robot 20 in the sterile work space 23 inside the chamber 11. Figure 2 is a front view showing the state in which the contamination detection portion of the robot arm has been moved into the sampling pod, as in the front view of Figure 1. Figure 3 is a plan view showing the state inside the chamber in the state shown in Figure 2. In Figures 2 and 3, the robot arm 22 of the articulated robot 20 has its tip portion (a portion of the robot hand 22a and the first robot arm 22b) inserted into the sampling pod 30. This portion is the localized contamination detection target (a predetermined portion of the robot arm 22) with the highest risk of contamination during aseptic work.

[0038] To detect contamination in a predetermined part of the robot arm 22 and to perform localized decontamination, it is necessary to seal the inside of the sampling pod 30 into which the predetermined part of the robot arm 22 is inserted, thereby eliminating communication with the inside of the chamber 11. If this is not done properly, it will not be possible to sample appropriate test air (described later) from the object to be detected as contaminated, and during decontamination, the decontamination agent will leak from the inside of the sampling pod 30 into the inside of the chamber 11. Therefore, the side wall of the sampling pod 30 is provided with a mechanism that adheres tightly to the outer circumference of the arm of the robot arm 22 and seals the inside of the sampling pod 30.

[0039] Figure 4 is a perspective view showing the sampling pod in two states: (A) with the insertion port open and (B) with the insertion port closed. In Figure 4(A), an insertion port 34 is open on one side 33 of the sampling pod 30. The other three sides are sealed by side walls. The insertion port 34 is provided with shutters 33a and 33b that open and close vertically, and each has a roughly semicircular opening 34a and 34b in its center that is large enough to cover and contact the outer circumference 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 a shutter closing device (not shown), sealing the inside of the sampling pod 30.

[0040] Figure 4(B) shows the state in which the insertion opening 34 is sealed. In Figure 4(B), on the side 33 of the sampling pod 30, shutters 33a and 33b, which are closed from the top and bottom, 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 and 33b, and the material of the contact portion between the shutters 33a and 33b and the approximately semicircular openings 34a and 34b are not particularly limited, but it is preferable that they be flexible resins that are resistant to decontamination agents. In this embodiment, a sheet of flexible epoxy resin was used. In this way, a predetermined portion of the robot arm 22 to be decontaminated is inserted into the inside of the sampling pod 30, and the contamination detection operation of the predetermined portion of the robot arm 22 is performed with the side 33 sealed.

[0041] <<Contamination detection procedure>> The contamination detection operation involves detecting the contamination status of a predetermined part of the robot arm 22 using a contamination detection device X. Figure 5 is a front view showing the state in which the contamination status of the robot arm is detected inside the sampling pod and a decontamination or cleaning operation can be performed. In Figure 5, the sampling pod 30 has one blower 31 positioned on the upper surface of the ceiling wall 35. In addition, a rectifier plate 36 made of screen mesh is provided below the ceiling wall 35 of the sampling pod 30.

[0042] The contamination detection device X includes a clean air supply device 41 that supplies clean air as contamination collection air 37 to a predetermined portion of the robot arm 22 via a blower 31. The contamination collection air 37 supplied from the clean air supply device 41 to the blower 31 via a supply pipe 41a is blown from the blower 31 into the sampling pod 30 via a ULPA filter 31a (a HEPA filter may also be used in some cases), and is blown onto the predetermined portion of the robot arm 22 as a unidirectional flow of contamination collection air 37 flowing from top to bottom. If the predetermined portion of the robot arm 22 is contaminated, the contaminants are captured in this air.

[0043] Air potentially containing contaminants (sample air) is collected as a unidirectional flow from top to bottom below the sampling pod 30 by a collector 45b equipped with the particle counter 45 and a collector 46b equipped with the bioparticle counter 46. The sample air collected by collectors 45b and 46b is sent to the particle counter 45 and bioparticle counter 46 via collection pipes 45a and 46a, respectively, where the level of contamination is detected.

[0044] Furthermore, since the contaminated air 37 is a unidirectional flow, it is preferable to move and rotate the first robot arm 22b in the forward and backward directions so that the contaminated air 37 is uniformly blown over a predetermined portion of the robot arm 22 (see the arrow attached to the first robot arm 22b in Figure 5). In addition, it is preferable to make the wind speed and airflow rate of the contaminated air blown from the blower 31 variable and adjust them appropriately based on the capacity of the sampling pod 30, the volume of a predetermined portion of the robot arm 22, the collection capacity of the collectors 45b and 46b, etc.

[0045] In addition, the air used to collect contaminants 37 may be supplied to a predetermined portion of the robot arm 22 via the blower 31, and compressed air may also be supplied from the compressed air supply device 44 shown in Figure 5 as contaminant collecting air and discharged (continuously or intermittently) to the surface of a predetermined portion of the robot arm 22 in the sampling pod 30 via a discharger (not shown) connected to the end of the supply pipe 44a. The shape and number of dischargers are not particularly limited, but it is preferable that they have a structure that allows for uniform discharge to the surface of the robot arm 22 and that they are arranged in multiple locations.

[0046] Furthermore, when capturing pollutants with the pollutant-collecting air 37, the ultrasonic vibrating disc 47 shown in Figure 5 is activated to apply ultrasonic vibrations and acoustic radiation pressure from the disc surface, thereby improving the efficiency of capturing pollutants.

[0047] Here, we will explain the particle counter 45 and bioparticle counter 46, which work in conjunction as contamination detection device X. The particle counter 45, also known as a fine particle measuring instrument, is a measuring instrument that counts dust, fine particles, impurities, etc. in the air. Inside the sampling pod 30, the sample air collected by the collector 45b from a predetermined part of the robot arm 22 is sent to the particle counter 45 via the collection pipe 45a, where laser light is irradiated onto the sample air and the size and number of fine particles are measured from the light scattering intensity. In this invention, in particular, the size and number of fine particles are measured by combining fine particles generated from joints etc. (hereinafter referred to as "non-biological fine particles") due to the operation of the robot arm 22 of the articulated robot 20 and cells, microorganisms etc. (hereinafter referred to as "biological fine particles") that adhere to the robot arm 22 during sterile work.

[0048] On the other hand, the bioparticle counter 46, also known as a parasitic bacteria counter, is a measuring instrument that, like the particle counter 45, counts parasitic bacteria contained in dust and fine particles in the air. In particular, it is preferable to use a bioparticle counter used in rapid microbiological testing (RMM). Inside the sampling pod 30, the sample air collected by the collector 46b from a predetermined part of the robot arm 22 is sent to the bioparticle counter 46 via the collection pipe 46a, where the sample air is irradiated with laser-excited fluorescence (LIF) to detect the autoluminescence caused by the components of the parasitic bacteria and measure the size and number of parasitic bacteria. In this invention, the size and number of bio-particles attached to the robot arm 22 are measured, particularly during sterile work.

[0049] Furthermore, the contamination detection device X may be equipped with one or more cameras 48 (see Figure 5). These cameras photograph the surface of a predetermined part of the robot arm 22 after the decontamination operation to confirm that no coarse particles or contaminants that are not detected by the particle counter 45 or bioparticle counter 46 are attached to the robot arm 22. In addition, photographs may be taken before the contamination detection operation, after the decontamination operation, and after the cleaning operation to confirm and record the contamination status 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 equipped 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 up an alert function that automatically issues a warning when the number of fine particles or bioparticles detected by the particle counter 45 or the bioparticle counter 46 exceeds a preset threshold.

[0051] In the contamination detection operation described above, if particulate matter or bio-particulate matter is detected by the particle counter 45 or bio-particulate counter 46, the following decontamination or washing operation is performed. If no particulate matter or bio-particulate matter is detected, the process proceeds to the second transport operation described below without performing the decontamination or washing operation.

[0052] Decontamination Operations The decontamination operation is performed when contaminants are detected from a predetermined part of the robot arm 22 during the contamination detection operation. In particular, it must be performed when bio-particles are detected by the bio-particle counter 46. The decontamination operation decontaminates only the predetermined part of the robot arm 22 inside the sampling pod 30. During the contamination detection operation, the 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 (Figure 4(B)). Also, 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 into the inside of the sampling pod 30 via the supply pipe 42a and a discharger (not shown) connected to the end of the supply pipe 42a.

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

[0054] Furthermore, when decontaminating a predetermined portion of the robot arm 22, the ultrasonic vibrating plate 47 shown in Figure 5 is activated to apply ultrasonic vibrations and acoustic radiation pressure from the plate surface, thereby improving the decontamination efficiency of the decontamination agent gas or mist.

[0055] Ventilation Operation Once the predetermined time for decontamination is complete, ventilation is performed. The ventilation operation removes any remaining decontamination agent inside the sampling pod 30 after decontamination using the ventilation device 32. First, aeration is performed to release any remaining hydrogen peroxide from inside the sampling pod 30. Aeration involves releasing clean air into the sampling pod 30 from the blower 31 of the sampling pod 30, while simultaneously decomposing and removing hydrogen peroxide using the ventilation device 32 equipped with a decomposition filter 32a.

[0056] Once the decontamination and ventilation operations are complete, a 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 relocation operation described below. However, even if no bio-particulate matter is detected during the contamination detection operation, if non-bio-particulate matter is detected, the following washing operation should be performed.

[0057] <Washing Procedure> The cleaning operation is performed when contaminants (only non-biological particulate matter) are detected from a predetermined part of the robot arm 22 during the contamination detection operation. In particular, it must be performed if no biological particulate matter is detected by the bioparticle counter 46, but non-biological particulate matter (the total number of particulate matter minus the number of biological particulate matter) is detected by the particle counter 45. The cleaning operation cleans only the 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 portion 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 (Figure 4(B)). Also, 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 into the inside of the sampling pod 30 via the supply pipe 43a and a discharger (not shown) connected to the end of the supply pipe 43a. After washing, the washing water is discharged out of the system from an outlet (not shown) provided at the bottom of the sampling pod 30. Alternatively, the predetermined portion 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 using compressed air, compressed air may be supplied from the compressed air supply device 44 of the cleaning mechanism Z as air cleaning air and discharged (continuously or intermittently) to the surface of a predetermined portion of the robot arm 22 inside the sampling pod 30 via a discharger (not shown) connected to the end of the supply pipe 44a. The shape and number of dischargers are not particularly limited, but it is preferable that they have a structure that allows for uniform discharge onto the surface of the robot arm 22 and that they are arranged in multiple locations.

[0060] Once the cleaning operation is complete, a contamination detection operation may be performed again to confirm the effectiveness of decontamination. If the effectiveness of decontamination is confirmed, proceed to the second transfer operation described below. However, if non-biological particulate matter is detected during the contamination detection operation, the cleaning operation should be performed again.

[0061] ≪Second movement operation≫ The second movement operation involves opening shutters 33a and 33b to remove a predetermined portion of the robot arm 22, which has been confirmed to be clean and free of contamination after the contamination detection operation is completed, from inside the sampling pod 30 and moving it to the sterile work space 23. This allows the next sterile operation to be performed without having to decontaminate and clean the inside of the chamber 11 and the articulated robot 20 placed inside it again. In this way, it is possible to perform the next sterile operation without having to decontaminate and clean the inside of the chamber 11 each time the object to be sterile is changed. These operations may also be automated by controlling them with a microcomputer.

[0062] As explained above, according to the present invention, the reliability of work in a sterile environment can be ensured by checking and recording the contamination status of a predetermined part of a robot arm that is likely to come into contact with powders, liquids, cells, etc. during work in a sterile environment, as well as the contamination status of foreign matter, dust, etc. generated or attached to the predetermined part of the robot arm, and by locally decontaminating the predetermined part of the robot arm when contamination is detected. [Explanation of symbols]

[0063] 10...Isolator body, 11...Chamber, 12...Ceiling and walls, 13... Blower, 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 workspace (critical area), 30...Sampling pod, 31...Blower, 32...Ventilation device, 32a...Decomposition filter, 33...side, 33a,33b...shutter, 34...insertion slot, 34a,34b...opening, 35...Ceiling and walls, 36...Rectifier plate, 37...Air for collecting contaminants, 41... Clean air supply device, 41a... Supply piping, 42... Decontamination agent supply device, 42a... Supply piping, 43... Washing water supply device, 43a... Supply piping, 44... Compressed air supply device, 44a... Supply piping, 45...Particle counter, 45a...Collection piping, 46... Bioparticle counter, 46a... Collection piping, X...Contamination detection device, Y...Decontamination mechanism, Z...Washing mechanism

Claims

1. The system comprises a sterile workroom capable of maintaining a sterile state, a robot equipped with a robotic arm installed inside the sterile workroom, a robotic arm inspection device that locally detects contamination in a predetermined portion of the robotic arm, and a contamination removal device that removes the detected contaminants. The robot arm inspection apparatus comprises a sampling pod that houses a predetermined portion of the robot arm, and a contamination detection device that detects dust generation and contamination status from the predetermined portion of the robot arm, the contamination detection device comprising a clean air supply means that supplies clean air to the predetermined portion of the robot arm, a 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 bio-particles containing microorganisms contained in the collected air. The decontamination device has a decontamination mechanism, which includes a decontamination agent supply device that supplies a decontamination agent into the sampling pod when operation is performed, and a ventilation device that removes the decontamination agent remaining in the sampling pod to maintain a sterile environment. In the sterile work space inside the sterile workroom, at an intermediate stage or completion stage of the sterile work performed by the robot, a first movement operation is performed to move a predetermined portion of the robot arm into the sampling pod; a contamination detection operation is performed to detect dust generation from the predetermined portion of the robot arm after movement and the contamination state due to the sterile work using the contamination detection device; a decontamination operation is performed to decontaminate the predetermined portion of the robot arm inside the sampling pod when contamination is detected; a ventilation operation is performed to remove any remaining decontamination agent inside the sampling pod using the ventilation device after decontamination; and a second movement operation is performed to move a predetermined portion of the robot arm from inside 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 a sterile state inside the sterile work chamber.

2. The sterile work system according to claim 1, characterized in that the decontamination mechanism of the contamination removal device is equipped with an ultrasonic vibrating plate to improve contamination detection efficiency and decontamination efficiency by the decontamination operation.

3. The decontamination device has a cleaning mechanism, the cleaning mechanism comprises 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 the aseptic work system according to claim 1 is characterized in that it performs a cleaning operation in addition to the decontamination operation.

4. The sterile work system according to claim 3, characterized in that the cleaning mechanism of the contamination removal device is equipped with an ultrasonic vibrator to improve contamination detection efficiency and cleaning efficiency through the cleaning operation.

5. The sampling pod has an insertion port into which a predetermined portion of the robot arm is inserted, and a sealing means provided at the insertion port. The sterile work system according to any one of claims 1 to 4, characterized in that the sealing means is in an open state when a predetermined portion of the robot arm is inserted into the sampling pod, and after the predetermined portion of the robot arm is inserted into the sampling pod, it adheres tightly to the outer circumference of the robot arm to seal the boundary between the inside of the sterile work chamber and the inside of the sampling pod.

6. The sterile 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 status of the surface of the robot arm before and after the decontamination operation.

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

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

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