Total Logging System

Abstract

Provided is a total logging system with which it is possible for the causes of trouble and the like to be investigated and countermeasures confirmed rapidly and appropriately, by comprehensively recording and accumulating workers, a work status, and a work environment for a series of operations using a sterile working device, and video recording and tracing the series of operations. The total logging system includes: an image capturing device for capturing images of the work status; an information exchanging device for exchanging information between a tag and a reader; various sensors for monitoring the internal environment of the sterile working device and the operating state of an inward / outward conveying mechanism and the like; and an information recording and accumulating device. The information recording and accumulating device authenticates a worker using information from the information exchanging device, and records work content relating to machines, instruments, and objects being processed, for example, involving the worker. Further, changes in the internal environment of the sterile working device, and the operating state of the inward / outward conveying mechanism, for example, are recorded using the information from the various sensors. The recorded information is indexed to correspond chronologically to the video, and is recorded and accumulated.

Description

[Technical field]

[0001] The present invention relates to a total logging system that records and accumulates information about workers, work conditions, work environment, etc., together with video images, regarding work in sterile work equipment such as isolators. [Background technology]

[0002] Work that is carried out in a clean atmosphere, for example, work in the manufacturing stage of pharmaceuticals or work in the manufacturing stage of semiconductors and electronic components, is carried out in a clean work environment that is kept sterile and dust-free to prevent the intrusion of contaminants from the external environment. Clean rooms are generally used as such work environments. Workers wearing dust-free clothing carry out their work in these clean rooms. However, in order to increase the sterility and dust-free assurance levels, even more advanced clean areas are constructed within the clean room and work is carried out there.

[0003] One method of constructing a highly clean area is to use an isolator, which uses a chamber sealed off from the outside environment, and workers work from outside the chamber using work gloves or wearing a half suit.

[0004] Another method for constructing a highly clean area is the use of RABS (Restricted Access Barrier System). In this RABS, an area surrounded by walls with an open lower part is provided in a part of the clean room, and a laminar flow of clean air flows in one direction from top to bottom inside the area, while strictly restricting access for workers. In this RABS, workers work through work gloves or the like provided on the walls.

[0005] In this way, pharmaceuticals and other products are manufactured in strictly controlled sterile environments such as isolators and RABS. Many of these tasks necessarily involve workers, directly or indirectly. For example, sterile vial dispensing equipment is used to dispense pharmaceuticals into containers such as vials inside an isolator. This dispensing equipment itself is installed inside the isolator in advance, and is decontaminated along with the inside of the isolator before use.

[0006] However, the filling needles, drug transport tubes, and other parts to be attached to the dispensing equipment, the vials to be filled, the drug solutions to be filled, and the rubber stoppers to be used after filling are all carried into the isolator, which is in a sterile state, by the workers. The work of attaching the carried-in filling needles to the dispensing equipment is also performed by the workers from outside the isolator, wearing work gloves, etc. Furthermore, even during the filling operation, the workers monitor the filling work inside the isolator to see if there are any abnormalities. For example, if a problem occurs, such as a vial falling over or being broken, the workers will deal with it wearing gloves.

[0007] Therefore, this series of work is recorded based on certain rules. For example, which worker performed what work and when is recorded. Furthermore, these records are currently managed by workers' self-reporting. In such a situation, there is a possibility that discrepancies, misunderstandings, and omissions in reporting may occur in the contents of reports by each worker. Therefore, it is difficult to identify the cause of the problem even by looking back at the records.

[0008] Meanwhile, the internal environment of the isolator is constantly monitored by various sensors for temperature, humidity, pressure, suspended dust, suspended bacteria, etc. The contents of these monitoring are also recorded in chronological order. Furthermore, when these sensors detect an abnormality, the operator takes action and records it according to a set of rules. However, it is difficult to identify the cause of the abnormality even by looking back at the records.

[0009] The internal pressure of the isolator is always kept positive relative to the outside in order to prevent contamination from the external environment. For example, when a worker performs the above-mentioned procedure using the work gloves of the isolator, the internal pressure of the isolator may change due to the removal and insertion of the work gloves from the isolator, causing an abnormality in which the positive pressure is temporarily not maintained. However, it has been very difficult to find the cause of such a temporary pressure abnormality. In addition, the airtightness of the work gloves is considered to be particularly important. In the case of work gloves that are frequently used by workers, if holes (pinholes) or tears occur in the main body of the gloves, the airtightness is broken, and it becomes impossible to maintain a highly sterile environment inside.

[0010] Therefore, it is desirable to accurately record the usage conditions of work gloves, such as the frequency of use, period of use, and type of work, and to inspect the airtightness and replace the work gloves according to a set rule. However, in reality, the management of work gloves was mainly done by inspecting the damage of work gloves after a certain period of time.

[0011] For example, work gloves that have been in use for a certain period of time are replaced according to a set rule. However, it is difficult to accurately grasp the actual usage status of each work glove before replacement. In reality, it is managed by workers' self-reporting and visual inspection. In such a situation, the load on each work glove will differ depending on the difference in the contents of the report by each worker, misunderstandings and omissions, and differences in the work content.

[0012] Therefore, it is necessary to identify the worker who wears each work glove and to accurately grasp the work content and working time. With this information, it is possible to accurately grasp the timing of airtightness inspection and replacement of each work glove. Furthermore, it is possible to accurately verify the occurrence of equipment troubles and work troubles from the frequency of use of the work gloves, and it is possible to quickly address safety issues.

[0013] Therefore, the present inventors have proposed a glove logging system as shown in the following Patent Document 1. This glove logging system records and accumulates the usage status, such as the user, frequency of use, period of use, and type of work, of each work glove worn in a device such as an isolator, thereby accurately determining the timing of air tightness inspection and replacement, thereby improving the safety of using work gloves and the work efficiency. [Prior art documents] [Patent documents]

[0014] [Patent Document 1] JP 2019-008565 A Summary of the Invention [Problem to be solved by the invention]

[0015] This glove logging system can trace glove operations when abnormal conditions occur during work, making it possible to retroactively check for inappropriate work, equipment abnormalities, etc. However, there are many problems caused by abnormalities other than the above pressure, or inappropriate work by workers in other operations, equipment abnormalities, etc., and a comprehensive system that can deal with these is required.

[0016] In particular, in pharmaceutical manufacturing, each element of equipment, personnel, and environment is essential. However, if no defects are found in the pharmaceutical manufacturing records, and a defective product is found in a subsequent quality inspection, etc., it is necessary to investigate the cause and take prompt action. However, with the conventional manufacturing record work of recording and storing the contents of various operations, it is not possible to investigate the cause quickly on the spot. Therefore, accumulated information that can reliably grasp the cause of the defect is required. Furthermore, since workers are involved, there is also human error, and it is difficult to identify which worker made what operation and when.

[0017] Therefore, the present invention addresses the above-mentioned problems and aims to provide a total logging system that comprehensively records and accumulates, in chronological order, a series of operations in sterile work equipment such as isolators and RABS, including operator authentication logs, operation logs of the work status, environmental logs of the work environment, and logs of opening / closing and connection of loading / unloading mechanisms and connection mechanisms, together with video footage, and that can trace the series of operations together with the video footage, making it possible to quickly and appropriately identify the cause of any problems and identify how to deal with them. [Means for solving the problem]

[0018] In order to solve the above problems, the inventors conducted extensive research and discovered that the above objectives could be achieved by attaching RFID tags or readers to workers working in isolators and RABS and to related equipment, and combining the worker logs, operation logs, environmental logs from environmental sensors, and opening / closing / connection logs from mechanism sensors obtained through information exchange with simultaneously captured video, thereby completing the present invention.

[0019] That is, according to claim 1, the total logging system of the present invention comprises: The operator must be in charge of the sterile work equipment, the machines and tools associated with said equipment, and the tools, reagents and objects to be processed that are brought into said equipment. Product A logging system that records and accumulates information on a series of work situations performed using the system, The system includes a photographing device that photographs the working conditions, an information exchange device that exchanges information between a tag and a reader, various sensors that monitor the state of the sterile working device, and an information recording and storage device that communicates and records information between the photographing device, the information exchange device, and the various sensors, The imaging device includes a first camera for imaging the inside of the sterile processing apparatus, The information exchange device is a tag attached to one or more operators working outside or inside the sterile work device, and a tag attached to the instruments, reagents, and objects to be processed that are brought into the sterile work device as necessary. Product and a tag for equipment and articles attached to the aseptic work device. Ingredients a device reader having an antenna attached thereto for reading information from each tag; The information recording and storing device records information on authenticating the worker based on the information received from the information exchange device as an authentication log, and records information on each worker and the machine, instrument, reagent, and processing object involved in the worker. Product record information specifying the work content as an operation log, and record information on the presence or absence of a change in the internal environment of the aseptic work apparatus based on the information received from the various sensors as an environment log; The authentication log, the operation log, and the environmental log are recorded and accumulated by chronologically corresponding each piece of information to the camera image captured by the imaging device and a callable index is assigned to a predetermined portion of the camera image.

[0020] According to claim 2, the present invention provides a total logging system according to claim 1, The photographing device includes, in addition to the first camera, a second camera for photographing the external surroundings of the sterile working apparatus, The authentication log, the operation log, and the environmental log are each associated with a chronological order in the camera image captured by the second camera, and a callable index is assigned to a predetermined portion of the camera image, so that the information is recorded and accumulated.

[0021] According to claim 3, the present invention provides a total logging system according to claim 1 or 2, The aseptic work apparatus has a highly aseptic area that maintains a high level of sterility within the aseptic area therein, The various sensors include an area sensor that monitors the highly sterile area, and the area sensor detects the presence of the operator or the machine, instrument, reagent, or object to be processed in the highly sterile area. Product The invention is characterized in that it detects an intrusion and transmits information to the information recording and storing device.

[0022] According to claim 4, the present invention further comprises the following: 3A total logging system according to claim 1, The various sensors include a particle counter (PC) for continuously monitoring particles in the highly sterile area, a real-time microorganism monitor (RMM) for continuously monitoring microorganism particles, and a pressure sensor (P) for monitoring the pressure in the sterile work device. do.

[0023] According to claim 5, the present invention provides a total logging system according to claim 1, The information exchange device is installed in the sterile work device. Transport a mechanism reader having an antenna attached to the entrance / exit mechanism and the connection mechanism with an external device for reading information from each tag; The various sensors include various environmental sensors that monitor the internal environment of the sterile working apparatus, and mechanism sensors that monitor the operating states of the loading / unloading mechanism and the connecting mechanism, the information recording and accumulating device records, based on the information received from the various environmental sensors, information on the presence or absence of a change in the internal environment of the aseptic working apparatus as an environmental log, and records, based on the information received from the mechanism sensors, information identifying each worker and the contents of the opening / closing / connecting operations of the loading / unloading mechanism and the connection mechanism in which the worker was involved as an opening / closing / connecting log; The authentication log, the operation log, the opening / closing / connection log, and the environmental log are recorded and stored by chronologically corresponding each piece of information to the camera image captured by the imaging device and by assigning a callable index to a predetermined portion of the camera image.

[0024] According to claim 6, the present invention provides a total logging system according to claim 5, The photographing device includes, in addition to the first camera, a second camera for photographing the external surroundings of the sterile working apparatus, The authentication log, the operation log, the opening / closing / connection log, and the environmental log are also associated with the camera image captured by the second camera in chronological order, and a callable index is assigned to a predetermined portion of the camera image, so that the information is recorded and accumulated.

[0025] According to claim 7, the present invention provides a total logging system according to claim 5 or 6, The aseptic work apparatus is a restricted access barrier system (RABS), The loading / unloading mechanism is a mechanism for loading / unloading a RABS into which the worker works, or into which the instruments, reagents, and objects to be processed are loaded. Product An openable door for carrying in, The door is characterized in that it is provided with the mechanism reader and the mechanism sensor.

[0026] According to claim 8, the present invention provides a total logging system according to any one of claims 1 to 7, The worker tag and the equipment / item tag are 、R It is characterized by being an FID. Effect of the Invention

[0027] According to the configuration of claim 1, the total logging system of the present invention has an imaging device, an information exchange device, various sensors, and an information recording and storage device, and records and stores information on a sterile work apparatus, machines and instruments associated with the sterile work apparatus, and instruments, reagents, and processing objects brought into the sterile work apparatus by an operator. Product Record and accumulate information about the series of work situations performed using the device.

[0028] The photographing device is provided with a first camera for photographing the inside of the sterile work apparatus, and photographs the working conditions related to the sterile work apparatus. The information exchange device is provided with a worker tag attached to one or more workers working outside or inside the sterile work apparatus, and a tag for each worker, and a tag for each worker, which is attached to one or more workers working outside or inside the sterile work apparatus ... ProductTags for equipment and articles to be attached to machines and equipment Ingredients The tag is attached to the equipment and has an antenna for reading information from each tag. Information is exchanged between the tag and the reader. Various sensors monitor the status of the sterile work equipment.

[0029] The information recording and storage device records and stores information exchanged between the imaging device, the information exchange device, and various sensors. Specifically, the information received from the information exchange device records the authentication information of the worker as an authentication log, and records the information of each worker and the machines, instruments, reagents, and processing objects involved in the worker. Product The information recording and accumulating device records information specifying the work content as an operation log. Also, based on information received from various sensors, information on the presence or absence of changes in the internal environment of the sterile work equipment is recorded as an environmental log. Furthermore, the information recording and accumulating device chronologically corresponds each piece of information on the authentication log, operation log, and environmental log to the camera images captured by the imaging device, and records and accumulates the information by assigning a callable index to a specific portion of the camera image.

[0030] This makes it possible to comprehensively record and accumulate the authentication log of the operator, the operation log of the work status, and the environmental log of the work environment in chronological order along with the video for a series of operations in sterile work equipment such as isolators and RABS.In addition, by using this to trace a series of operations along with the video records, it is possible to quickly and appropriately identify the cause of a problem and confirm how to deal with it.

[0031] According to the configuration of claim 2, the photographing device may include a second camera that photographs the outside surroundings of the sterile operating apparatus in addition to the first camera. Also, each piece of information of the authentication log, operation log, and environment log is recorded and accumulated in chronological order with respect to the camera image photographed by the second camera, and a callable index is assigned to a predetermined portion of the camera image. This makes it possible to more effectively exert the above-mentioned operational effects.

[0032] According to the configuration of claim 3, the aseptic work device may have a highly sterile area within the sterile area inside the device, which maintains a high level of sterility. In this case, the various sensors include an area sensor that monitors the highly sterile area. This area sensor detects the presence of an operator or a machine, instrument, reagent, or object to be processed in the highly sterile area. Product Intrusion is detected and information is transmitted to the information recording and storing device, whereby the above-mentioned effects can be more effectively achieved.

[0033] According to the configuration of claim 4, the various sensors may include a particle counter (PC) for continuously monitoring particles in the highly sterile area, a real-time microorganism monitor (RMM) for continuously monitoring microbial particles, and a pressure sensor (P) for monitoring the pressure inside the aseptic working device. This makes it possible to more specifically achieve the above-mentioned effects.

[0034] According to the configuration of claim 5, the information exchange device includes a mechanism reader in addition to the worker tag, the equipment / goods tag, and the equipment reader. The mechanism reader is installed in the sterile operating device. Transport The device is provided with antennas that are attached to the entry / exit mechanism and the connection mechanism with an external device to read information from each tag, and exchanges information between the tag and the reader. In addition, the various sensors include various environmental sensors that monitor the internal environment of the sterile work device, and mechanism sensors that monitor the operating conditions of the entry / exit mechanism and the connection mechanism.

[0035] The information recording and accumulating device records information on the presence or absence of changes in the internal environment of the sterile work equipment as an environmental log based on information received from various environmental sensors.In addition, based on information received from the mechanism sensors, it records information identifying each worker and the contents of the opening / closing / connection operations of the loading / unloading mechanism and the connection mechanism in which the worker was involved as an opening / closing / connection log.Furthermore, the information recording and accumulating device chronologically corresponds each piece of information on the authentication log, operation log, opening / closing / connection log, and environmental log to the camera images captured by the imaging device, and records and accumulates them by assigning a callable index to a specific part of the camera image.

[0036] This allows a series of operations in sterile work equipment such as isolators and RABS to be comprehensively recorded and stored in chronological order along with video footage, including operator authentication logs, operational logs of the work status, environmental logs of the work environment, and logs of the opening / closing and connection of loading / unloading mechanisms and connection mechanisms.By tracing the series of operations along with the video records, it is possible to quickly and appropriately identify the cause of any problems and identify how to deal with them.

[0037] According to the configuration of claim 6, the photographing device may include a second camera that photographs the outside surroundings of the sterile work apparatus in addition to the first camera. Also, each piece of information of the authentication log, operation log, opening / closing / connection log, and environment log is recorded and accumulated in chronological order with respect to the camera image photographed by the second camera, and a callable index is assigned to a predetermined portion of the camera image. This makes it possible to more effectively exert the above-mentioned operational effects.

[0038] According to the configuration of claim 7, the aseptic work device is a restricted access barrier system (RABS), and the loading / unloading mechanism is a mechanism for loading / unloading an operator into the RABS or an instrument, a reagent, or an object to be processed into the RABS. Product The device may have an openable door that can be used when bringing it in. The door is provided with a mechanism reader and a mechanism sensor. This makes it possible to more specifically achieve the above-mentioned effects.

[0039] According to the configuration of claim 8, the worker tag and the equipment / goods tag are 、R In this case, the above-mentioned effects can be more specifically exhibited. [Brief description of the drawings]

[0040] [Figure 1] This is a schematic diagram showing the basic configuration of an isolator equipped with a total logging system. [Diagram 2] This is an image showing the appearance of an isolator equipped with a total logging system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] The total logging system according to the present invention will be described in detail below. Here, a total logging system equipped in an isolator will be described as an example. However, the present invention is not limited to isolators, and the same can be applied to RABS (Restricted Access Barrier Systems). Figure 1 is a schematic diagram showing the basic configuration of an isolator equipped with a total logging system.

[0042] In Fig. 1, an isolator 10 has a highly sterile area 11 (critical area 11) depending on the work carried out therein, and a higher level of sterility is maintained in this area than in other areas. In this critical area 11, important operations such as filling pharmaceuticals and culturing cells for regenerative medicine are carried out. In addition, work gloves 12 are provided on the wall of the isolator 10 so that workers can carry out their work from outside. Although three work gloves 12 are shown in Fig. 1, the number is not particularly limited.

[0043] A sterile connection port 13 (RTP13) for carrying an object from the external environment into the isolator 10 is provided on the side wall of the isolator 10. A pass box or the like may be provided instead of or in addition to the RTP13. As various sensors for monitoring the internal environment of the isolator 10, an air sampler 14 (AS14) for monitoring airborne bacteria and dust inside and a particle counter 15 (PC15) are provided. A rapid microorganism tester 16 (RMM16) for monitoring the sterility state inside the isolator 10 is also provided. The PC15 and RMM16 may be configured to focus on monitoring the critical area 11.

[0044] Also provided are a pressure sensor 17 (P17), a temperature sensor 18 (Temp18), a humidity sensor 19 (RH%19), a gas concentration detector 20 (Conc20), a condensation sensor 21 (SDM21), and an anemometer 22 (Vel22) for measuring wind speed in the critical area 11. Also provided are an enzyme indicator 23 (EI24) and a biological indicator 23 (BI23) for checking the decontamination effect inside the isolator 10. The gas concentration detector 20, the enzyme indicator 23 (EI24), and the biological indicator 23 (BI23) are used only during decontamination.

[0045] Next, the configuration of a total logging system that records and accumulates various operations in the isolator 10 equipped with many devices and sensors will be described. The components of the total logging system according to the present invention mainly consist of a photographing device, an information exchange device (tag and reader), various sensors, and an information recording and accumulation device. In FIG. 1, only a first camera 25 that photographs the inside of the isolator 10 is shown as the photographing device, but a second camera (described later) that photographs the outside periphery of the isolator 10 may also be provided. Note that the first camera 21 and the second camera are preferably video cameras or digital cameras that can capture moving images. Also, multiple cameras of each may be used so that the entire working area can be photographed.

[0046] The information exchange device identifies and records the work contents by exchanging information between the tag and the reader. The tags include a worker tag 26 attached to a worker A working outside or inside the isolator 10, and an equipment / goods tag attached to a machine / tool ​​installed inside or outside the isolator 10 and to tools / reagents / processing items (medicines, cells, etc.) brought into the isolator 10. The types of these tags are not particularly limited, and may be RFID (radio frequency identification) or the like in which information identifying the attached worker and the tools / reagents / processing items is written. In FIG. 1, the worker A has an RFID attached to his chest as the worker tag 26. On the other hand, the equipment / goods tag is not shown in FIG. 1, but is mainly attached to tools, reagents, processing items, etc. brought into the isolator during work.

[0047] On the other hand, as for readers, equipment readers equipped with antennas that read information from each tag are attached to machines, tools, etc. In Fig. 1, although not shown, they are attached to the critical area 11, work gloves 12, sterile connection port 13 (RTP 13), air sampler 14 (AS 14), particle counter 15 (PC 15), and rapid microorganism test device 16 (RMM 16). These readers have a limited receiving area for exchanging information with tags, and detect when a worker or brought-in tools, reagents, or processed items approach the range (receiving area) where the equipment is handled.

[0048] The various sensors are the sensors 14 to 22 described above, and the information sensed by each sensor is transmitted to and recorded in an information recording and storage device described below. In addition, an alarm device or a stop device is activated in response to an abnormal value. In FIG. 1, a critical area 11 exists inside the isolator 10. In this case, an area sensor is provided to monitor the critical area 11 and detects workers, objects, materials to be processed, etc. that enter this area.

[0049] The information recording and storage device first authenticates the worker who is about to work in the isolator 10. This is done by exchanging information with the worker tag 26 (RFID) worn by the worker and by the ID and password written by the worker. This information is recorded as an authentication log. Next, information identifying each identified worker and the work content of the machine, tool, object to be processed, etc. in which the worker was involved is received from each reader of the information exchange device, and the information identifying these workers and the work content is recorded as an operation log. In addition, information on the presence or absence of changes in the internal environment of the isolator 10 is recorded as an environmental log based on information received from various sensors.

[0050] Although not shown in Fig. 1, a personal computer may be used as the information recording and storage device. In this case, the personal computer communicates with each reader via wireless LAN and receives information from each RFID tag read by each reader and information from various sensors. If the reader has a reader / writer function, the personal computer writes information into each RFID tag via each reader. From this information, the personal computer also records and stores the identification of the worker (authentication log), the work time, work content, etc. (operation log), and environmental information (environment log) for each task.

[0051] Next, the information recording and storage device chronologically corresponds each piece of information about the authentication log, operation log, and environmental log for the series of tasks to the camera images (continuous images) taken by the first camera 25 and, if necessary, a second camera (27 described below), and records and stores them by assigning recallable indexes to specific points in the camera images (especially the start and end of the tasks).

[0052] FIG. 2 is an image showing the exterior of an isolator equipped with a total logging system. In FIG. 2, the isolator 10 is placed on the floor of a clean room (not shown). The inside of the isolator 10 is a chamber in which a sterile state is maintained. The inside of the chamber is not shown. Furthermore, the image in FIG. 2 does not show the filter unit for intake and exhaust of air equipped in the isolator 10, the blower for exhausting air to the outside after filtering through the filter unit, or a transparent glass window through which the inside can be seen.

[0053] In Fig. 2, work gloves 12 are attached to the side wall of the isolator 10. Note that in Fig. 2, a total of six work gloves 12 (three pairs) are attached. Also, a sterile connection port 13 (RTP 13) is provided on a wall surface of the isolator 10. Also, an air sampler 14 is provided on another wall surface. Note that other equipment is not shown in Fig. 2.

[0054] Moreover, beside the isolator 10 and the work gloves 12, a worker A who performs work using the work gloves 12 is standing. A worker tag 26 (RFID) is attached to the chest area of ​​the worker A.

[0055] 2, a first camera 25 that photographs the inside of the isolator 10 and a second camera 27 that photographs the external periphery of the isolator 10 are provided as imaging devices for photographing the working status. Further, a reader 28 that detects a tag (RFID) inside the isolator 10 is provided near the first camera 25. Further, a reader 29 that detects a tag (RFID) outside the isolator 10 is provided near the second camera 27.

[0056] A reader 30 is provided on the work glove 12 attached to the side wall of the isolator 10. Readers 31 and 32 are provided on the sterile connection port 13 and the air sampler 14, respectively. These readers 30, 31, and 32 detect that the RFID of worker A has entered their respective receiving areas and record that worker A is working with the device.

[0057] The total logging system according to the present invention will be described below with reference to each embodiment. Note that the present invention is not limited to the following embodiments. Note that the following embodiments are not described with reference to drawings, and therefore, each element is not labeled with a reference symbol.

[0058] (First embodiment) In this first embodiment, we will explain how to operate using a sterile vial dispensing device installed inside an isolator equipped with a chamber in a grade A sterile state. Specifically, vials are transported into a sterile environment, and the drug solution is continuously and aseptically filled therein, and then the vials are rubber stoppered and sealed with aluminum caps in a sterile environment. The basic configuration of the total logging system is as described above.

[0059] First, when worker A enters the clean room, he attaches an RFID tag to the chest area of ​​his clean clothing. Next, worker A has the RFID information read by a reader in the authentication device, and inputs his own ID and password into a personal computer. At this time, the personal computer, which communicates with the reader, collates the input ID and password with stored information to identify worker A. Note that instead of collating worker A with the RFID tag, a reader with a reader / writer function (for both reading and writing) may be used to input information about the user, worker A, into the RFID tag at this stage. Additionally, worker authentication may be performed using biometric authentication, QR code (registered trademark), barcode, or the like.

[0060] Next, worker A begins preparation work for filling sterile vials with liquid medicine in the isolator. First, he makes preparations to aseptically carry sterilized filling needles and liquid medicine delivery tubes, etc., into the isolator via an RTP (Rapid Transfer Port) equipped in the isolator to be attached to a sterile vial filling device. First, he connects a container containing sterilized filling needles and liquid medicine delivery tubes, etc., to the RTP. At this time, the RFID of worker A enters the receiving range of the antenna of a reader equipped near the RTP, and it is read and recorded that it is worker A who is operating the RTP.

[0061] This timing triggers the continuous image data captured by the video camera W installed outside the isolator to be given a callable index containing information such as the work time, worker information, and work content. When the work is completed and worker A leaves the RTP, the time when the worker leaves the receiving area of ​​the antenna of the reader installed close to the RTP is recorded as the work completion time.

[0062] Next, Worker A opens the lid inside the isolator of the RTP using the work gloves attached close to the RTP, and carries the sterilized filling needle and drug solution delivery tube into the isolator. At that time, the RFID of Worker A enters the receiving area of ​​the antenna of the reader provided close to the work gloves, and it is read and recorded that it is Worker A who is operating the work gloves.

[0063] Furthermore, when a sensor installed in the work glove detects that worker A's arm has entered the work glove, information such as the work time, worker information, and work content is added as a callable index to the continuous image data captured by video camera W installed outside the isolator and video camera X installed inside the isolator. When the work is finished, the time when worker A removes his / her hand from the work glove and leaves the receiving area of ​​the antenna of the reader installed close to the work glove is also recorded as the work end time.

[0064] Next, worker A attaches the sterilized filling needle and drug solution delivery tube that have been carried into the isolator to the filling section of the sterile vial filling machine. When worker A approaches the work gloves that are close to the filling section to attach the filling needle to the filling section, the RFID of worker A enters the receiving range of the antenna of the reader provided close to the work gloves, and it is read and recorded that it is worker A who is operating the work gloves. Furthermore, a sensor provided on the work gloves triggers the entry of worker A's arm into the work gloves, and information such as the work time, worker information, and work content is added as a callable index to the continuous image data captured by video camera W provided outside the isolator and video camera X provided inside the isolator.

[0065] Next, worker A attaches the filling needle to the filling section through the work gloves. At that time, the worker A works in a highly sterile area (critical area) in the isolator where extremely critical work is performed when aseptically filling vials such as the filling section with drug solution. An area sensor that detects movement is attached to this critical area, and the sensor reacts to the gloved work of worker A. This signal is used as a trigger to further add information such as the work time in the critical area, worker information, and work content to the image data captured by video camera W installed outside the isolator and video camera X installed inside the isolator as a callable index. The end time of the work is also recorded as the time when worker A's RFID leaves the receiving area of ​​the antenna of the reader installed close to the work gloves.

[0066] Next, Worker A carries the rubber stoppers of the sterilized vials into the isolator. First, Worker A connects the container containing the rubber stoppers of the sterilized vials to the RTP. At this time, Worker A's RFID tag enters the receiving area of ​​the antenna of the reader installed near the RTP, and it is read and recorded that it is Worker A who is operating the RTP. This timing triggers the image data captured by the video camera W installed outside the isolator to be given information such as the work time, worker information, and work content as a callable index. The end time of the work is similarly recorded as the point in time when Worker A's RFID tag leaves the receiving area of ​​the antenna of the reader installed near the RTP.

[0067] Next, the lid of the port of the RTP is opened using a work glove attached close to the RTP, and the rubber stopper of the sterilized vial is carried into the isolator. At that time, the RFID tag of the worker A enters the receiving area of ​​the antenna of the reader attached close to the work glove, and it is read and recorded that it is the worker A who is operating the work glove. Furthermore, the sensor attached to the work glove triggers the entry of the arm of the worker A into the work glove, and information such as the work time, worker information, and work content is added as a callable index to the image data captured by the video camera W attached outside the isolator and the video camera X attached inside the isolator. The end time of the work is similarly recorded as the time when the RFID tag of the worker A leaves the receiving area of ​​the antenna of the reader attached close to the work glove.

[0068] Now that the preparation work for filling sterile vials with medicinal liquids is complete, next, Worker A operates the sterile vial filling device installed inside the isolator and begins the work of continuously filling vials with medicinal liquids. The details of these operations are recorded in a recording device separately installed in the sterile vial filling device.

[0069] Next, we will explain the operation of the total logging system during the sterile vial filling operation. Isolators are equipped with various sensors to constantly monitor the state of the isolator, and constantly monitor whether there are any abnormalities in the internal sterile environment. Representative environmental monitors include pressure sensors (P), air velocity sensors (Vel), temperature sensors (Temp), and humidity sensors (RH%). In highly sterile areas (critical areas) within isolators, such as the sterile drug filling section, where the extremely critical operation of aseptically filling vials with drug solutions is performed, particle counters (PC) that continuously monitor microbial particles in the environmental air, and real-time microbial monitors (RMM) may be installed. Below, we will explain examples of using these sensors as triggers.

[0070] If an abnormality occurs in the filling equipment during the sterile vial filling operation (for example, a vial falls (toppled bottle) or breaks (broken bottle) on the vial transport line), an abnormality signal will be emitted from the filling equipment, and an operator may be required to stop the filling equipment and take action to resolve the abnormality. If a toppled bottle occurs on the vial transport line, an abnormality signal is emitted by the filling equipment's sensor, and the filling equipment stops, Operator A will need to remove the toppled bottle. Operator A approaches a work glove located near the vial transport line where the toppled bottle occurred in order to use the work glove to remove the toppled bottle.

[0071] At that time, the RFID tag of worker A enters the receiving area of ​​the loop antenna of the reader provided in close proximity to the work gloves, and it is read and recorded that it is worker A who is operating the work gloves. Furthermore, a sensor provided on the work gloves detects that worker A's arm has entered the work gloves, and information such as the work time, worker information, and work content is added as a callable index to the continuous image data captured by video camera W provided on the outside of the isolator and video camera X provided on the inside. The end time of the work is similarly recorded as the point in time when worker A's RFID tag leaves the receiving area of ​​the antenna of the reader provided in close proximity to the work gloves.

[0072] Furthermore, if glove work is performed during such a filling operation, the pressure in the isolator may fluctuate as the arm is put in and taken out of the work glove. Since large pressure fluctuations may affect the sterile environment of the isolator, similarly, when an abnormality occurs in the signal from the pressure sensor attached to the isolator, information such as the time when the abnormality occurred, the worker information, the work content, etc. are added as a callable index to the continuous image data captured by the video camera W installed outside the isolator and the video camera X installed inside the isolator. When the abnormality is triggered, information such as the work time, the worker information, the abnormality information, etc. are added as a callable index to the continuous image data captured by the video camera X installed inside the isolator.

[0073] It is also assumed that microbial particles may be detected by the RMM monitor during the sterile vial filling operation, and in that case too, an abnormal signal from the monitor will trigger the continuous image data captured by video camera W installed outside the isolator and video camera X installed inside the isolator to include information such as the time of occurrence, operator information, and abnormality details as a callable index. At the same time, as a function of the filling device, an appropriate number of vials are automatically removed from the filling device before and after the abnormal signal is issued from the RMM monitor. When the RMM monitor returns to normal, information on the end time is added to the continuous image data as a callable index.

[0074] After the above sterile vial filling work is completed, a check is made to see if there were any defects in the work based on the manufacturing record. During the check, images within the time range required for confirmation, around the time of occurrence and end when the index information is added, are instantly extracted from the consecutive images indexed at each work based on the index information, and the images are confirmed and compared with the manufacturing record. Furthermore, the extracted index information and image data are separately electronically stored together with the manufacturing record by tamper-proof software. This makes it possible to firmly guarantee the consistency of the manufacturing record information (data integrity (DI)).

[0075] Second embodiment In this second embodiment, the state of cell culture work for regenerative medicine will be described. First, the isolator is equipped with a chamber and a pass box in a grade A sterile state, and is placed on the floor of a clean room. The clean room is also equipped with an incubator (culture device) that can be connected to the isolator for cell culture. The isolator is also equipped with a centrifuge for separating cells collected from a culture dish. In addition to work gloves, a facility called a half suit is also provided so that the worker can enter and perform more complicated culture operations in the isolator. Furthermore, a pass box is used instead of an RTP. The basic configuration of the total logging system is as described above.

[0076] In this second embodiment, first, workers B and C who enter the clean room attach RFID tags to the chest area of ​​their clean clothing. Next, workers B and C have the RFID information read by a reader and input their own IDs and passwords into a personal computer. At this time, the personal computer communicating with the reader collates the input IDs and passwords with stored information to identify workers B and C. Note that instead of collating workers B and C with the RFID tags, a reader with a reader / writer function (for both reading and writing) may be used to input information on users, workers B and C, into the RFID tags at this stage. Furthermore, workers may be authenticated by biometric authentication, QR codes (registered trademark), bar codes, or the like.

[0077] Next, worker B begins preparations for cell culture for regenerative medicine in the isolator. First, he prepares to bring in the containers, instruments, culture medium, buffer, and reagents necessary for cell culture into the isolator through a pass box installed in the isolator. First, worker B decontaminates the exterior of containers and instruments that have been sterilized in sterilization bags, etc., and containers containing culture medium, buffer, reagents, etc. that have been sterilized in advance by filter sterilization, etc., with hydrogen peroxide, and then brings them into the isolator.

[0078] When Worker B approaches the pass box to work, Worker B's RFID enters the receiving area of ​​the antenna of the reader installed near the door of the pass box, and it is read and recorded that it is Worker B who is operating the pass box. This timing triggers continuous image data captured by video camera Y installed outside the isolator to be given information such as the work time, worker information, and work content as a recallable index. When the work is finished, Worker B closes the door of the pass box and leaves the pass box, and the point at which he leaves the receiving area of ​​the antenna of the reader installed near the door of the pass box is recorded as the end of the work.

[0079] After that, Worker B uses a hydrogen peroxide decontamination device installed in the pass box to decontaminate and sterilize the exterior of the above-mentioned items. This decontamination operation is recorded in a recording device installed in the isolator and the pass box.

[0080] Next, worker B opens the door of the pass box on the isolator side using the work gloves attached close to the pass box, and carries the decontaminated goods into the isolator. At that time, the RFID of worker B enters the receiving area of ​​the antenna of the reader attached close to the work gloves, and it is read and recorded that it is worker B who is operating the work gloves. Furthermore, a sensor attached to the work gloves triggers the entry of worker B's arm into the work gloves, and information such as the work time, worker information, and work content is added as a callable index to the continuous image data captured by video camera Y attached outside the isolator and video camera Z attached inside the isolator. When the work is finished, the time when worker C removes his hand from the work gloves and leaves the receiving area of ​​the antenna of the reader attached close to the work gloves is also recorded as the work end time.

[0081] Next, worker B carries the culture dish containing the cells cultured in the incubator into the isolator. In order to carry the culture dish in the incubator into the isolator, worker B brings the incubator close to the joint with the isolator and mechanically connects and seals it. When worker B approaches the joint, he enters the receiving area of ​​the antenna of the reader provided near the joint, and it is read and recorded that it is worker B who is performing the connecting operation. Furthermore, a sensor provided at the joint triggers the connecting operation, and information such as the work time, worker information, and work content is added as a callable index to the continuous image data provided on the video camera Y provided outside the isolator. The time when worker B's RFID leaves the receiving area of ​​the antenna of the reader provided near the joint is also recorded as the work end time.

[0082] Next, Worker B decontaminates the joint between the isolator and the incubator with hydrogen peroxide using equipment installed in the isolator. The decontamination work is recorded on a recorder installed in the isolator.

[0083] When decontamination of the joint is completed, the door of the joint with the incubator inside the isolator is opened and the culture dish is carried into the isolator. At that time, worker C works wearing a half suit provided inside the isolator.

[0084] First, when worker C approaches the entrance of the half suit to enter the half suit, he enters the receiving area of ​​the antenna of the reader installed near the entrance, and it is read and recorded that it is worker C who is operating the half suit. Next, worker C who entered the half suit uses the half suit to open the door of the joint between the isolator and the incubator. At that time, the signal of the sensor installed on the door is used as a trigger to further add information such as the work time in the half suit, worker information, and work content as a callable index to the continuous image data taken by the video camera Z installed inside the isolator. After that, worker C uses the half suit to carry the culture dish where the culture has been completed from inside the incubator into the isolator. The end time of the work is recorded in the same way as the time when the sensor installed on the door of the joint between the isolator and the incubator confirms the signal that the door is closed.

[0085] Next, we will explain the operation of the Isolator Total Logging System in cell culture for regenerative medicine. In cell culture for regenerative medicine, a complicated operation called subculture is performed in which medium, buffer, reagents, etc. are added to a culture dish using a pipette, the cells are separated and collected from the culture dish, the cell dispersion is transferred to a centrifuge bottle, the cells are separated by centrifugation, and the cells are seeded on a culture dish to which new medium, etc. has been added. The highly sterile area where extremely critical work such as subculture is performed is positioned as the critical area. An area sensor that detects movement is attached to this critical area.

[0086] Furthermore, this critical area is equipped with a reader for recording RFID tags attached to tools used in the subculture operation, such as the culture dish on which cells have been cultured, the empty culture dish, the centrifuge bottle, the medium, the buffer, the reagent, the pipette, etc. Worker C places the culture manipulation objects, such as the culture dish on which cells have been cultured, the empty culture dish, the centrifuge bottle, the medium, the buffer, the reagent, the pipette, etc., into the critical area using the half suit. At that time, the reader enters the receiving range of the antenna provided in the critical area, and the RFID tags of the culture manipulation objects are read and recorded.

[0087] Furthermore, subculture work is performed in the critical area using the half suit. At this time, an area sensor installed in the critical area detects the movement of the work glove part of the half suit, and the signal is used as a trigger to add information such as the work time in the critical area, worker information, and work content to continuous image data captured by a video camera Z installed inside the isolator as a callable index. The end time of the work is also recorded as the point in time when the signal from the area sensor in the critical area is no longer detected.

[0088] Isolators are equipped with various sensors to constantly monitor the status of the isolator, and constantly monitor whether there are any abnormalities in the internal sterile environment. Representative environmental monitors include pressure sensors (P), air velocity sensors (Vel), temperature sensors (Temp), and humidity sensors (RH%). In highly sterile areas (critical areas) where extremely critical work such as subculture work in cell culture for regenerative medicine is carried out in a sterile manner, particle counters (PC) that continuously monitor microbial particles in the environmental air, and real-time microbial monitors (RMM) may be installed. Below, we will explain an example of the operation of a total logging system using these sensors as triggers.

[0089] It is also assumed that microbial particles may be detected on the RMM monitor during subculture work. In that case, an abnormal signal from the monitor is used as a trigger to add information such as the time of occurrence, operator information, and abnormality details to the continuous image data captured by the video camera Z installed inside the isolator as a callable index. Furthermore, if the sensors installed in the isolator emit an abnormal signal during subculture work, the abnormal signal is also used as a trigger to add information such as the time of occurrence, operator information, and abnormality details to the continuous image data captured by the video camera Z installed inside the isolator as a callable index. In the event of an abnormality, the operator C appropriately removes the culture operation items such as the culture dish in which the cells were cultured at that time, the empty culture dish, the centrifuge bottle, the medium, the buffer, the reagent, and the pipette from the critical area, and the continuous images at that time are also given information such as the time of occurrence, operator information, and operation details as a callable index.

[0090] After the series of subculture operations is completed, the culture dish on which the cells have been newly seeded is carried into the incubator. Worker C uses the half suit to open the door at the joint between the isolator and the incubator. At that time, the signal from the sensor on the door is used as a trigger to add information such as the work time, worker information, and work content, etc., to the continuous image data captured by the video camera Z installed inside the isolator as an index that can be recalled by the half suit. Then, Worker C uses the half suit to carry the culture dish on which the cells have been seeded from inside the isolator into the incubator. The end time of the operation is recorded in the same way as the time when the sensor on the door at the joint between the isolator and the incubator confirms the door closing signal.

[0091] Next, operator B detaches the incubator from the isolator, returns the incubator to the installation site, and begins culturing. When operator B approaches the connection part, he / she enters the receiving area of ​​the antenna of the reader installed near the connection part, and it is read and recorded that it is operator B who is performing the detachment operation. Furthermore, the sensor installed at the connection part uses the detachment operation as a trigger to add information such as the operation time, operator information, and operation content to the continuous image data recorded on video camera Y installed outside the isolator as a callable index.

[0092] After the above regenerative medicine cell culture work is completed, a check is made to see if there were any defects in the work based on the manufacturing record. During the check, images within the time range required for confirmation, around the time of occurrence and end when index information is added, are instantly extracted from the consecutive images indexed at each work step based on the index information, and the images are confirmed and compared with the manufacturing record. Furthermore, the extracted index information and image data are electronically stored separately together with the above manufacturing record by tamper-proof software. This makes it possible to firmly guarantee the consistency of the manufacturing record information (data integrity (DI)).

[0093] Third embodiment In this third embodiment, a worker D works in the RABS using the total logging system. First, the RABS is placed on the floor of a clean room, and is structured to keep the manufacturing equipment in a sterile state by surrounding the entire equipment inside with a hard wall and creating a one-way flow of grade A air within an area where personnel intervention is strictly limited. In this third embodiment, a sterile vial dispensing device is installed in the RABS, which transports vials in a sterile environment, fills them with drug solutions continuously and aseptically, and then seals the vials with rubber stoppers and aluminum caps in a sterile environment. The basic configuration of the total logging system is as described above.

[0094] First, worker D who enters the clean room attaches an RFID tag to the chest area of ​​his / her clean gown. Next, worker D has the RFID information read by a reader and inputs his / her own ID and password into a personal computer. At this time, the personal computer that communicates with the reader collates the input ID and password with stored information to identify worker D. Note that instead of collating worker D with the RFID, a reader with a reader / writer function (for both reading and writing) may be used to input information about the user, worker D, into the RFID at this stage.

[0095] Next, worker D begins preparation work for filling sterile vials with medicinal liquids in the RABS. First, he prepares to bring sterilized filling needles and medicinal liquid delivery tubes, etc., into the RABS through an openable door provided on the RABS to be attached to the sterile vial filling device. First, he brings in a container containing sterilized filling needles and medicinal liquid delivery tubes, etc., through an openable door provided on the RABS. At this time, worker D's RFID enters the receiving range of the antenna of a reader provided near the RABS door, and it is read and recorded that it is worker D who is operating the door.

[0096] Furthermore, when the door sensor detects that the door is open, information such as the work time, worker information, and work content is added as a recallable index to the continuous image data captured by video camera E installed outside the RABS and video camera F installed inside the RABS. When the work is finished, worker D goes outside and closes the door, and the point in time when the door sensor detects that the door is closed is also recorded as the work end time.

[0097] Next, the worker D uses the work gloves attached close to the filling device to open it, and moves the sterilized filling needle and the drug solution delivery tube to the vicinity of the filling section in the RABS. At that time, the RFID of the worker D enters the receiving area of ​​the antenna of the reader attached close to the work gloves, and it is read and recorded that it is the worker D who is operating the gloves. Furthermore, a sensor attached to the work gloves triggers the entry of the arm of the worker D into the work gloves, and information such as the work time, worker information, and work content are added as a callable index to the continuous image data captured by the video camera E attached outside the RABS and the video camera F attached inside the RABS. When the work is finished, the time when the worker D removes his / her hand from the work gloves and leaves the receiving area of ​​the antenna of the reader attached close to the work gloves is also recorded as the work end time.

[0098] Next, worker D attaches the sterilized filling needle and drug solution delivery tube that have been brought into the RABS to the filling section of the sterile vial filling machine. When worker D approaches the work gloves that are close to the filling section to attach the filling needle to the filling section, he enters the receiving range of the antenna of the reader provided close to the work gloves, and it is read and recorded that it is worker D who is operating the gloves. Furthermore, a sensor provided on the work gloves detects that worker D's arm has entered the work gloves, and information such as the work time, worker information, and work content is added as a callable index to the continuous image data captured by video camera E provided on the outside and video camera F provided on the inside of the RABS.

[0099] Next, worker D attaches the filling needle to the filling section through the work gloves. At that time, the worker works in a highly sterile area (critical area) in the RABS where extremely critical work is performed when aseptically filling vials such as the filling section with drug solution. An area sensor that detects movement is attached in this critical area, and the sensor reacts to the gloved work of worker D. This signal is used as a trigger to add information such as the work time in the critical area, worker information, and work content to the continuous image data captured by video camera E installed outside the RABS and video camera F installed inside the RABS as a recallable index. The end time of the work is also recorded as the time when worker D's RFID tag leaves the receiving area of ​​the antenna of the reader installed close to the work gloves.

[0100] Next, worker D carries the rubber stoppers of the sterilized vials into the RABS. First, worker D opens the door of the RABS and carries the container containing the rubber stoppers of the sterilized vials into the RABS. At this time, worker D's RFID tag enters the receiving range of the antenna of a reader installed near the RABS door, and it is read and recorded that it is worker D who is operating the door. Furthermore, the timing when the sensor that detects the opening and closing of the door detects that the door is open is used as a trigger to add information such as the work time, worker information, and work content to the continuous image data captured by video camera E installed outside the RABS and video camera F installed inside the RABS as a recallable index. The end time of the work is similarly recorded as the time when worker D goes outside and closes the door, and the sensor that detects the opening and closing of the door detects that the door is closed.

[0101] Next, the lid of the hopper of the supplying device is opened using a work glove attached close to the rubber stopper supplying device for vials, and the rubber stoppers of the sterilized vials are placed into the hopper. At that time, the RFID tag of the worker D enters the receiving area of ​​the antenna of the reader attached close to the work glove, and it is read and recorded that it is the worker D who is operating the glove. Furthermore, the sensor attached to the work glove triggers the entry of the arm of the worker D into the work glove, and information such as the work time, worker information, and work content are added as a callable index to the continuous image data captured by the video camera E attached outside the RABS and the video camera F attached inside the RABS. The end time of the work is similarly recorded as the time when the RFID tag of the worker D leaves the receiving area of ​​the antenna of the reader attached close to the work glove.

[0102] Now that the preparation work for filling sterile vials with medicinal liquid is complete, next, Operator D operates the sterile vial filling device installed in the RABS and begins the work of continuously filling vials with medicinal liquid. The details of these operations are recorded in a recording device separately installed in the sterile vial filling device.

[0103] Next, we will explain the operation of the Total Logging System during the sterile vial filling operation. RABS is equipped with various sensors to constantly monitor the RABS status and constantly monitor whether there are any abnormalities in the internal sterile environment. Typical environmental monitors include a particle counter (PC) that continuously monitors microbial particles in the ambient air, an air velocity sensor (Vel), a temperature sensor (Temp), and a humidity sensor (RH%). In highly sterile areas (critical areas) within the RABS, such as the sterile drug solution filling section, where the extremely critical operation of aseptically filling vials with drug solutions is performed, a real-time microbial monitor (RMM) that continuously monitors microbial particles in the ambient air may be installed. We will explain examples of using these sensors as triggers.

[0104] During the sterile vial filling operation, if any abnormality occurs in the filling device (for example, a vial falls (toppled bottle) or breaks (broken bottle) in the vial transport line), an abnormality signal is sent from the filling device, and an operator may be required to stop the filling device and perform an operation to resolve the abnormality. If a bottle falls on the vial transport line, an abnormality signal is sent by the sensor of the filling device, and the filling device stops, operator D must remove the fallen bottle. In this case, operator D uses a work glove located near the vial transport line where the fallen bottle occurred to remove the fallen bottle, and when operator D approaches the work glove, the work glove enters the receiving range of a loop antenna provided in a reader provided near the work glove, and it is read and recorded that it is operator D who is performing the glove operation.

[0105] Furthermore, when a sensor installed in the work gloves detects that worker D's arm has entered the work gloves, information such as the work time, worker information, and work content is added as a callable index to the continuous image data captured by video camera E installed on the outside of the RABS and video camera F installed on the inside. The end time of the work is similarly recorded as the time when worker D's RFID tag leaves the receiving area of ​​the antenna of the reader installed close to the work gloves.

[0106] In addition, in the case of a RABS, it is possible that when an abnormality occurs, there may be cases where there are no work gloves nearby. In such cases, it may be necessary to temporarily open a door installed in the RABS and have a worker enter and fix the abnormality. As mentioned above, when a fallen bottle occurs in the vial transport line, an abnormality signal is sent by the sensor of the filling device, and the filling device stops, if there are no work gloves near the fallen bottle, worker D must open the door installed in the RABS, enter the room, and remove the fallen bottle. At this time, the RFID of worker D enters the receiving range of the antenna of a reader installed near the RABS door, and it is read and recorded that it is worker D who is operating the door.

[0107] Furthermore, when the door sensor detects that the door is open, information such as the work time, worker information, and work content is added as a callable index to the continuous image data captured by video camera E installed outside the RABS and video camera F installed inside the RABS. The end time of the fallen bottle removal work by Worker D inside is similarly recorded as the time when Worker D goes outside and the door sensor detects that the door is closed.

[0108] It is also assumed that the RMM monitor may detect microbial particles during the sterile vial filling operation. In that case, the monitor's abnormal signal will trigger the addition of information such as the time of occurrence, operator information, and abnormality details as a callable index to the continuous image data captured by video camera E installed outside the RABS and video camera F installed inside the RABS. At the same time, as a function of the filling device, an appropriate number of vials may be automatically removed before and after the abnormal signal is output from the RMM monitor, but there are also cases where operator D enters the device and removes the abnormal vial, as in the case of the fallen bottle removal described above. In that case, the continuous image data is recorded in the same way as when the door is opened and the operator enters the device. When the RMM monitor returns to normal, information on the end time is added as a tag to the continuous image data.

[0109] After the above sterile vial filling work is completed, a check is made to see if there were any defects in the work based on the manufacturing record. During the check, images within the time range required for confirmation, around the time of occurrence and end, to which index information is added, are instantly extracted from the consecutive images indexed at each work step based on the index information, and the images are confirmed and compared with the manufacturing record. Furthermore, the extracted index information and image data are separately electronically stored together with the manufacturing record by tamper-proof software. This makes it possible to firmly guarantee the consistency of the manufacturing record information (data integrity (DI)).

[0110] As described above, the present invention can comprehensively record and accumulate, in chronological order, a series of operations in sterile work equipment such as an isolator or RABS, together with video, including the authentication log of the operator, the operation log of the work status, the environmental log of the work environment, and the open / close / connection log of the loading / unloading mechanism and the connection mechanism.By utilizing this to trace a series of operations together with the video records, it is possible to quickly and appropriately identify the cause of a problem and confirm how to deal with it.

[0111] The present invention is not limited to the above-described embodiments, but may be modified in various ways as follows. (1) In the above embodiments, RFID tags are used as tags, but the present invention is not limited to these and other tags may be used. In particular, for worker authentication, biometric authentication such as eye or fingerprint authentication, or QR code (registered trademark) or barcode may be used. (2) In each of the above embodiments, communication between the reader and the information recording and storing device is via wireless LAN, but this is not limited to this and wired communication may also be used. [Explanation of symbols]

[0112] 10…Isolator, 11…Highly sterile area (critical area), 12...Work gloves, 13...Sterile connection port (RTP), 14...Air sampler (AS), 15...Particle counter (PC), 16...Rapid microbiological testing device (RMM), 17...Pressure sensor (P), 18...Temperature sensor (Temp), 19...Humidity sensor (RH%), 20...Gas concentration detector (Conc), 21...Condensation sensor (SDM), 22...Anemometer (Vel), 23...Biological indicator (BI), 24...Enzyme indicator (EI), 25...First camera, 27...Second camera, 26...Worker tag (RFID), 28, 29, 30, 31, 32...Readers.

Claims

1. A logging system that records and accumulates information regarding a series of work situations performed by an operator using a sterile work apparatus, as well as machines and instruments associated with the sterile work apparatus, and instruments, reagents, and items to be processed that are brought into the sterile work apparatus, The system includes an imaging device that captures images of the working conditions, an information exchange device that exchanges information between a tag and a reader, various sensors that monitor the state of the sterile working device, and an information recording and storage device that communicates, records, and stores information between the imaging device, the information exchange device, and the various sensors, The imaging device includes a first camera for imaging the inside of the sterile processing apparatus, The information exchange device includes an operator tag attached to one or more operators working outside or inside the sterile work apparatus, an equipment / item tag attached to the instruments, reagents, and items to be processed that are brought into the sterile work apparatus as necessary, and an equipment reader equipped with an antenna that is attached to machines and instruments associated with the sterile work apparatus to read information from each tag, the information recording and accumulating device records, based on the information received from the information exchange device, information that authenticates the worker as an authentication log, records information that identifies each worker and the work content of the machine, instrument, reagent, or object to be processed in which the worker was involved as an operation log, and records, based on the information received from the various sensors, information on the presence or absence of a change in the internal environment of the sterile work apparatus as an environment log; A total logging system characterized in that each piece of information of the authentication log, the operation log and the environmental log is chronologically associated with the camera image captured by the imaging device, and a callable index is assigned to a specific portion of the camera image, thereby recording and storing the information.

2. The photographing device includes, in addition to the first camera, a second camera for photographing the external periphery of the sterile working apparatus, The total logging system described in claim 1, characterized in that each piece of information of the authentication log, the operation log, and the environmental log is also associated with a chronological order with the camera image captured by the second camera, and a callable index is assigned to a specific location in the camera image, and the information is recorded and stored.

3. The aseptic work apparatus has a highly aseptic area that maintains a high level of sterility within the aseptic area therein, The total logging system described in claim 1 or 2, characterized in that the various sensors include an area sensor that monitors the highly sterile area, and the area sensor detects intrusion of the worker or the machine, instrument, reagent, or item to be processed into the highly sterile area and transmits information to the information recording and storage device.

4. The total logging system according to claim 3, characterized in that the various sensors include a particle counter (PC) that continuously monitors particles in the highly sterile area, a real-time microorganism monitor (RMM) that continuously monitors microbial particles, and a pressure sensor (P) that monitors the pressure within the sterile work apparatus.

5. the information exchange device includes a mechanism reader having an antenna attached to a carry-in / out mechanism and a connection mechanism with an external device installed in the sterile work apparatus to read information from each tag; The various sensors include various environmental sensors that monitor the internal environment of the sterile working apparatus, and mechanism sensors that monitor the operating states of the loading / unloading mechanism and the connecting mechanism, the information recording and accumulating device records, based on the information received from the various environmental sensors, information on the presence or absence of a change in the internal environment of the sterile working apparatus as an environmental log, and, based on the information received from the mechanism sensors, records, as an opening / closing / connection log, information identifying each worker and the contents of the opening / closing / connection operations of the loading / unloading mechanism and the connection mechanism in which the worker was involved; The total logging system according to claim 1, characterized in that each piece of information of the authentication log, the operation log, the opening / closing / connection log, and the environmental log is recorded and stored by corresponding it in chronological order to the camera image captured by the imaging device and assigning a callable index to a specific portion of the camera image.

6. The photographing device includes, in addition to the first camera, a second camera for photographing the external periphery of the sterile working apparatus, The total logging system described in claim 5, characterized in that each piece of information of the authentication log, the operation log, the opening / closing / connection log, and the environmental log is also associated with the camera image captured by the second camera in chronological order, and is recorded and stored by assigning a callable index to a specified location in the camera image.

7. The aseptic work apparatus is a restricted access barrier system (RABS), The carry-in / out mechanism is an openable / closable door used when the worker works inside the RABS or when the instrument, the reagent, or the object to be treated is brought into the RABS, 7. The total logging system according to claim 5, wherein the door is provided with the mechanism reader and the mechanism sensor.

8. 8. The total logging system according to claim 1, wherein the worker tag and the equipment / item tag are RFID tags.

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