JP2010233478A - Safety management system in cell processing facility - Google Patents

Abstract

The present invention provides a safety method and apparatus related to workers and products in a cell processing facility.
An information management system unit for managing various manufacturing information in association with a manufacturing number in each process of product manufacturing, a monitoring system unit for recording an environmental state of a work facility including a work room at regular intervals, and the process information Environmental condition monitoring means for monitoring whether or not the environmental condition data obtained from the matrix information comprising the environmental data and the environmental condition data is within a certain threshold, and when a work facility whose data deviates from the threshold is detected, the deviation is detected. A safety management system comprising alarm means for issuing a corresponding warning and a database 96 for storing warning processing data corresponding to a data level corresponding to the corresponding work process in advance. The alarm means obtains the process in the equipment that deviates from the threshold value from the information management system unit 38, reads the corresponding warning processing data from the database 96, and individually displays the warning processing according to the level for each monitor attached to the corresponding equipment. To do.
[Selection] Figure 1

Description

  The present invention relates to a safety management system in a cell processing facility, and more particularly to a safety management system capable of ensuring safety related to workers and products in a cell processing facility.

  When various organs and tissues of a human are in a deficient state, dysfunction or dysfunction, it is necessary to transplant cells and tissues to regenerate the lost function. Medical technology that reconstructs organs and tissue functions is collectively called “regenerative medicine”. In regenerative medicine, human cell / tissue-use products (hereinafter referred to as products) manufactured by manufacturing and culturing human cells / tissues are used.

Since the preparation of the product is transplanted to a person without final sterilization in an environment that prevents contamination of dust and microorganisms from the outside, assurance of the sterility of the product is required.
The product is manufactured by aseptic operation and is required to have a high quality that requires the assurance of sterility similar to that of a pharmaceutical injection solution.

  Manufacturing facilities for such products (CPF: Cell Processing Facilities or CPC: Cell Processing Center) are used to manufacture human cell / tissue products (hereinafter referred to as products) that are cells / tissues necessary for regenerative medicine. In addition, it is a facility that mainly consists of Bio Clean Room (BCR) necessary for cell and tissue preparation, and accepts, manufactures, tests, and stores raw materials. The CPF is set up in universities, hospitals, companies, etc.

  The CPF is configured by combining small compartments, and from the viewpoint of ensuring the sterility described above, the staff in each room will work in isolation and are isolated from the outside.

  If the work of the CPF staff is not performed in accordance with a predetermined procedure, the quality required as a cell / tissue use product used in regenerative medicine cannot be secured. In the concept of quality assurance such as GMP (Good Manufacturing Practice), the work of CPF must be carried out according to the procedure determined by the instructions (manufacturing instructions for products using cells and tissues). Since the disciplined work behavior of the staff becomes the standard, if the behavior is managed by the computer system, the abnormality of the staff described below is determined to be a deviation from the discipline.

  For this reason, in the CPF, there is a tendency that a computer system is introduced into various management tasks, and a system for appropriately realizing various types of management has been proposed. Patent Document 1 discloses a management system related to cell culture and a management method related to cell culture.

By the way, in this kind of computer system, for example,
(1) A computer system that collects and manages environmental values such as facility temperature, humidity, room pressure, and the number of suspended particulates,
(2) A computer system that collects and manages performance values such as temperature, the number of suspended particulates, and carbon dioxide concentration of the manufacturing equipment of the facility,
(3) Computer system that collects and manages facility entrance / exit records and entrance / exit records for each room,
(4) There are computer systems that collect information on facility manufacturing instructions and manufacturing records.

In addition, there is a fire alarm system necessary for buildings.
For example, in the computer systems of (1) and (2), when the performance of the working room and the manufacturing equipment (eg, temperature / humidity / room pressure / cleanliness / carbon dioxide concentration) is monitored and deviates from the control standard value It is a system that issues adjustments and alarms for devices such as air conditioners.

  The computer system (3) performs record management of facility entrances and rooms, for example, door unlocking operation by reading an IC card or biometric authentication, and record management of the operator. For example, if there is a record of entering a room at 13:00 and there is no record of leaving the room after 22:00, it is determined that there is an abnormality in the safety of some staff. An alarm can be issued.

  The computer system (4) is intended for product manufacturing instructions and record management. For example, there is a record in which operation A is performed at 14:00. If the action is correct, the operation B should be recorded within 10 minutes, but there is no record of the operation B of the staff even after 1 hour. This state can be alarmed as one of warning judgment information for the safety of the staff. This is called an audit trail (also referred to as an audit trail), and performs a series of operation records with an accurate time stamp (date and time automatically stamped by a computer).

JP 2004-290140 A

  However, although the computer system used in the CPF may issue a warning of deviation of the management value for each information collection, it is recognized as information for grasping the safety status of the staff and products in the facility. Not.

An object of this invention is to provide the safety method and apparatus which concern on the operator and product in a cell treatment plant.
More specifically, the first object is to allow people working in the facility to escape more safely when there is a disaster or the like.

  Secondly, the best means that can be used at that time, such as containing the product you are working on (for example, if there is a virus, etc.) inside as much as possible without diffusing it outside, is displayed according to the situation at hand. It is an object of the present invention to provide a system that can be made to operate.

  Third, CPF products are made-to-order products, and once they are suspended due to a disaster, etc., they are usually discontinued, but they can continue to be manufactured even if they are in other facilities as much as possible. An object is to provide a system capable of indicating an appropriate treatment.

SUMMARY An advantage of some aspects of the invention is to solve at least a part of the problems described above, and the invention can be implemented as the following configuration example.
That is, the safety management system in the cell processing facility according to the present invention firstly includes manufacturing information (operator, working room, work date, processing step information, equipment used in each step of product manufacturing in the cell processing facility. Information management system unit that manages product records in association with product serial numbers and environmental data (including temperature, humidity, pressure, cleanliness, etc.) of work equipment including work rooms. Environmental state data obtained by generating matrix information composed of a monitoring system unit that records at regular time intervals, process information from the information management system in the work facility, and environmental state data from the monitoring system, and obtained from the matrix information Environmental condition monitoring means for monitoring whether or not the value is within a certain threshold, and the environmental condition in the matrix information Alarm means for issuing a warning according to the deviation between the detected environmental state data and the threshold value when a work facility deviating from a certain threshold value indicating abnormality is detected, and a threshold value corresponding to the corresponding work process in advance A database for storing warning processing data according to a level of environmental condition data that has been removed is provided, and the warning means acquires a work process in a work facility that deviates from the threshold value from the information management system, and corresponds to the corresponding work process in advance. The warning processing data is read from the database, and warning processing including product processing support corresponding to the environmental state data level deviating from the threshold value is displayed separately for each monitor attached to the corresponding work equipment in conjunction with the warning. Yes.

  Further, in the above configuration, the database stores worker evacuation route data for each work facility according to an environmental state data level that deviates from the threshold in conjunction with a warning, and the alarm means includes an environment deviating from the threshold. When a warning is given to the monitor attached to the work room according to the state, when the worker needs to be evacuated according to the environmental state data level, the operator has a function to monitor and display the evacuation route of the worker. It is a feature.

  Further, in the above configuration, in the safety management system in the cell processing facility, the database indicates a method for securing a product in production in each work process for each work facility according to an environmental state data level that deviates from a threshold value together with a warning. The warning means is capable of displaying a product securing method on a monitor in a work room corresponding to an environmental condition that deviates from a threshold value.

  Further, in the above configuration, the database stores data instructing a method for preventing the scattering of the product according to the environmental state data level deviating from the threshold value together with the warning, and the work room corresponding to the environmental state deviating from the threshold value is stored. It is possible to display a product scattering prevention method on the monitor according to an alarm level that requires prevention of scattering of the product being manufactured.

  In addition, in the above configuration, the monitoring system unit can input data from an external alarm system unit outside the cell processing facility through a communication line, and the database can perform each operation according to a warning level corresponding to the outside facility data. Warning processing data in each work process of the room is stored, and the warning means individually performs warning processing corresponding to the work process in each work room according to the data outside the facility for each monitor attached to the corresponding work equipment. It is characterized by being displayed.

  According to the safety management system in the cell processing facility as described above, it is possible to predict an abnormality in safety in the CPF as much as possible in advance and notify the related parties. And according to the contents of the warning and warning, the handling of the product and the behavioral standard of the staff are set in advance, and safer response than before is possible.

It is a block diagram which shows the whole structure of the safety management system in the cell processing facility which concerns on this invention. It is a structural example of the cell processing facility to which the same safety management system is applied. It is a structural example of the safety management system applied about one of the work rooms. It is a some configuration block diagram of the monitoring system in the safety management system. It is an example of composition of an information management system. It is an example of the matrix data produced | generated by the safety management system. It is an example of a screen display of an evacuation guidance warning. It is a screen display example of product scattering prevention support. It is an example of the warning process data by a pressure change. It is an example of warning processing data when a minor fire occurs.

  Hereinafter, the present invention will be described in detail with reference to embodiments shown in the drawings. However, this embodiment is merely an illustrative example, and various modifications may be employed within the scope in which the technical idea of the invention is common.

  A configuration example of a cell processing facility (CPF) to which the present invention is applied is shown in FIG. As shown in the figure, CPF10 is centered on the bioclean room (BCR) necessary for preparing cells and tissues in order to produce human cells and tissues that are necessary for regenerative medicine. The raw material storage chamber 12, the preparation chamber 13, the reagent preparation chamber 14, the cell preparation chamber 16, the sterility inspection chamber 18, the test inspection chamber 20, the freezing storage chamber 22, and the cleaning and sterilization chamber 24 for receiving and storing raw materials. A small room such as a management room 26 provided with computer equipment is combined.

The safety management system 30 applied in such a CPF 10 is basically configured to include the following processing unit.
(A) An information management system section (for example, using a computer system) is provided for instructing the work contents and procedures of the staff and recording the results of the work. By including the management of time and operator's operation history, the presence of the staff's room is indirectly judged.
(B) A monitoring system will be installed to collect and manage the indoor environment (for example, temperature, humidity, number of suspended particles, and pressure) in which the staff works. Analyze changes in indoor pressure, changes in the number of particles in the room, and temporary changes in room temperature and humidity due to the opening and closing of doors due to staff entry.
(C) Install a monitoring system that collects and manages the performance of machines and equipment installed to manufacture products (eg, incubator temperature, refrigerator temperature, and number of suspended particulates in the safety cabinet).
(D) Establish a system to constantly collect and manage public external crisis information.
(E) Install a system for collecting and managing information from instruments that detect disaster signs in advance (for example, seismometers, smoke detectors, camera monitoring records, fire detectors) in the CPF.
(F) Install a system that automatically records (IC card, IC tag, biometrics) management of staff entry and exit.

  Then, the management data of (a) to (f) (or some combination thereof) is mathematically analyzed, and the safety level of staff (degree of danger), the quality of products, etc. (products, raw materials of products, etc.) And a system to notify the degree of safety. For the notification, warning processing according to the degree of risk such as a treatment level (for example, an employee evacuates immediately from the CPF) and a warning level (the employee gathers around the evacuation exit to see the situation) is performed. I am doing so.

  The overall conceptual configuration of the safety management system is shown in FIG. Basically, each of the working chambers 32a, 32b, ... (raw material storage chamber 12, reagent preparation chamber 14, cell preparation chamber 16, sterility inspection chamber 18, test inspection chamber 20, frozen storage chamber 22, management chamber 26, etc. ) In which the monitoring system unit 36 acquires environmental state data 34 (34a, 34b, 34c,...) Indicating what time, where, and what environmental state (temperature, humidity, pressure, fire information, etc.) The work room 32 (32a, 32b,...) Includes an information management system unit 38 that manages when, where, and what work is being performed.

  FIG. 3 shows a configuration example of a safety management system applied to one work room 32. Five computer system processing units are provided between the work room 32 and the computer management room 26, and the computer management room 26 is provided with a computer system processing unit for integrating them.

  First, in order to monitor the entrance / exit of the staff to / from the work room 32, the reading antenna 42 of the IC tag 40 carried by the staff is installed, and a first computer 44 for inputting the entrance / exit detection signal is provided. The first computer 44 identifies a staff member from the IC tag 40 and records the date of entry / exit in association with the work room 32. Therefore, this constitutes the entrance / exit management system processing unit 46.

  In addition, the work chamber 32 is equipped with a bar code reader 48 for specifying processing target cells and a work terminal 50 having an input board. The work terminal 50 displays work contents based on an instruction (work instruction) 54 (see FIG. 1) provided through the second computer 52 on the management room side, inputs work records, and results records. 52, production record data 56 (see FIG. 1) such as product name, production number, process name, work room number, worker name, etc. is output. Therefore, the bar code reader 48, the work terminal 50, and the second computer 52 constitute an information management system unit 38.

  Further, in order to collect and manage environmental state data 34 such as pressure, temperature, humidity, and number of suspended particles in the working chamber, a chamber pressure sensor 58, a room temperature sensor 60, a humidity sensor 62, and a suspended particle sensor 64 are provided in the working chamber 32. It is arranged. A third computer 66 for inputting these detection signals is installed in the computer management room 26 and records and holds the environmental state data 34 in time series. This system processing unit is an indoor environment monitoring system unit 36A. Here, it is possible to analyze pressure fluctuations in the room, fluctuations in the number of fine particles in the room, and temporary fluctuations in room temperature and humidity due to opening and closing of the door due to the entrance and exit of staff.

  In addition, it is deployed in the work room 32 to collect and manage the performance of the machines and devices installed to manufacture the product (for example, the temperature of the incubator, the temperature of the refrigerator, the number of suspended particles in the safety cabinet). A temperature sensor 68 and a floating particle sensor 70 for detecting the temperature of the incubator and the safety cabinet and the number of suspended particles are provided. Of course, it goes without saying that environmental state data such as the temperature of other devices such as a freezer and a refrigerator (not shown) can be detected. On the other hand, the computer management room 26 side is equipped with a fourth computer 72 for inputting sensor signals. Therefore, these constitute a device monitoring system unit 36B.

  FIG. 4 shows a configuration example in which the indoor environment monitoring system unit 36A and the equipment monitoring system unit 36B are applied to a plurality of work rooms. For example, the raw material storage chamber 12 of each work chamber 32 is provided with equipment such as a freezer 12A and a refrigerator 12B, and the temperature of the auxiliary equipment is measured by a sensor, and third and fourth monitoring data are provided as time series data. The data is taken into the computers 66 and 72. Similarly, the reagent preparation chamber 14 detects the cleanliness of the safety cabinet 14A that performs the reagent preparation work, and measures the temperature, humidity, pressure, cleanliness, etc. of the room with a sensor. The cleanliness of the cabinet 16A, the temperature of the incubator 16B and the carbon dioxide gas concentration are measured, and the temperature, humidity, pressure, and cleanliness of the other rooms are measured, and are similarly taken into the computers 66 and 72 as time series data. In other work chambers 32 (not shown), the environmental state data required according to the work contents is measured and taken into the computers 66 and 72 as time series data. The monitoring computers 66 and 72 have functions for displaying the current value, trend display, alarm display, and measure in each work room 32, and these can be displayed on the screen. In addition, there are alarm reference values and measure reference values as internal set values, and this reference value can be compared with the current value and switched according to the deviation level so that alarm display / measure display can be made. It has become. Further, it can be output to the outside and alarmed by another display or sound.

  As shown in FIG. 3, in the work room 32, in addition to the monitoring system units 36 </ b> A and B described above, a monitoring camera 74 is installed in the work room 32, and image processing is performed by the fifth computer 76. The fifth computer provides a visual management system. Furthermore, a fire detector 78 and a smoke detector 80 are provided in the work room 32 so that an alarm is output when a fire occurs by the fire notification system 82 of the computer management room 26.

  The various sensors in the work room 32 and the computer system unit in the computer management room 26 are connected via a relay panel 84, and the sensing data of the plurality of work rooms 32 are transferred to the computers 44, 52, 66, via the relay panel. 72 and 76, the state management of the plurality of work chambers 32 is performed.

  Furthermore, in this embodiment, data can be input from the external alarm system unit 85 outside the cell processing facility through the communication line (network) 83 so that weather information and earthquake information can be taken into the safety management system. Yes.

  The monitoring system using the monitoring camera 74, the fire alarm system 82, and the system using the external alarm system unit 85 constitute a third monitoring system unit 36C.

  Here, as described above, the second computer 52 of the information management system unit 38 sends the display of the work content based on the instruction (work instruction) 54 (see FIG. 1) to the work terminal 50, and the work terminal. In the process of manufacturing the product in the cell processing facility (cell culture process, cell preparation process, cell observation process, cell shipping process) Manufacturing information including work date, equipment used, and manufacturing record is managed in association with the product serial number.

  One role in the information management system unit 38 is to manage the entire process from sample collection to cell culture processing until the final sample administration between the hospital (research facility) 86 and the CPF 10. There is. The processing procedure here is as shown in FIG.

  That is, the hospital (research facility) 86 and the CPF 10 are connected via the information network 88, and the sample collection processing S1 is input using the computer of the hospital (research facility) 86 as an input terminal. This process is a procedure of reception, sample collection, screening, and culture request.

  On the CPF 10 side, when the culture request is confirmed, the sample is carried into the CPF 10, and the sample reception process S2 is started by the computer equipped in the CPF 10. In the sample acceptance process S2, a sample acceptance test is performed, and if the received cells are appropriate, a manufacturing plan is constructed. Accompanying the formulation of the manufacturing plan, the necessary materials are accepted and the accepted materials are registered, and the process proceeds to the next cell preparation / culture process S3.

  In the cell preparation / cultivation process S3, the instructions prepared in the manufacturing plan are approved, and the preparation of raw materials, execution of work, record of results, confirmation of records are performed in accordance with the instructions, and adjustment / culture Process. When the culture is completed, the process proceeds to a storage process S4 for the cultured cells, and processes such as storage confirmation, storage, and inventory are performed. In addition, the shipping process S5 is performed in response to a shipping request from the hospital (research facility) 86 side. When the shipping request is accepted, the requested cell is confirmed, and after packaging, the hospital (research) Ship to facility) 86.

  On the other hand, in the hospital (research facility) 86, the sample administration process S6 is performed. Based on the administration plan, a request for shipment of the cells cultured on the CPF 10 side is made, and the cultured cells conveyed thereby are sent. Do the administration after confirming the identity.

  Through such a series of processing, a continuous operation from specimen collection to cell culture and specimen administration is performed between the hospital (research facility) 86 and the CPF 10.

  In the formulated instruction 54, the details of the work are instructed in culturing and adjusting the target specimen. In cell culture work, it is necessary to carry out work procedures according to this instruction accurately. For this reason, in each work room in the CPF 10, the environmental state in each work process according to the instruction is defined.

  Therefore, in the present embodiment, matrix information composed of process information from the information management system unit and environmental state data from the monitoring system is generated, and the environmental state data 34 obtained by the matrix information is within a certain threshold. Environmental state monitoring means for monitoring whether or not there is provided. As shown in FIG. 3, the environmental condition monitoring means includes computers 44, 52, 66, 72, 76 of each system unit including an entrance / exit management system unit 46, an information management system unit 38, and a monitoring system unit 36. , 82 is constituted by an integrated computer 90 that performs input / output communication. The integrated computer 90 acquires data from at least the information management system unit 38 and the monitoring system unit 36, and, as shown in FIG. 6, each work process (cell culture process, cell culture process, cell For each observation process, cell shipment process, etc., matrix data 92 including environmental state data strings such as temperatures in each work room (preparation room, preparation room, storage room, culture room, etc.) is generated, and database 96 (FIG. 1) is generated. See). That is, the data sheet 94A in the cell culturing process lists each work room name in the horizontal heading row, and lists environmental condition data items (temperature, pressure, fire, earthquake, etc.) in the vertical heading row. The measurement environment state data during the cell culture process can be displayed on the matrix table. This is created for each work process (94B, 94C...).

  It should be noted that the matrix data 92 in FIG. 6 is virtual, and in fact, if the integrated computer 90 can output the environmental state data 34 in each work room 32 for each work process on demand. Good. The display data of each matrix data 92 displays the environmental condition data 34 that changes from moment to moment from the monitoring system unit 36. The data can be displayed on the screen in the integrated computer 90, and the data portion corresponding to the work process performed in the work terminal 50 of each work room 32 can be cut out and output and displayed.

  The integrated computer 90 monitors whether the environmental state data obtained from the matrix data 92 is within a certain threshold. This is because the deviation is obtained by comparing the threshold value composed of the reference value of the environmental condition defined by the instruction manual 54 or the equipment manual and the measured environmental condition data, and concentrated according to the deviation level. The alarm panel 98 is activated to activate the alarm panel 100 and the speaker 102 in the corresponding work room. Similarly, the centralized alarm panel 98 is activated according to the scale when a fire or earthquake occurs, and the alarm panel 100 and the speaker 102 in the corresponding work room are activated. The alarm is also displayed on the work terminal 50 of each work room 32 at the same time. That is, the integrated computer 90 and the alarm panels 98 and 100 detect the detected environmental condition data and the threshold value when a work facility in which the environmental condition data in the matrix data information deviates from a certain threshold value indicating abnormality is detected. A means for issuing a warning according to the deviation is configured. The alarm means obtains a work process in the work facility including the work room 32 outside the threshold value from the information management system unit 38, and reads warning process data corresponding to the corresponding work process from the database 96 in advance. In addition to the warning, warning processing including product processing instructions corresponding to the environmental state data level deviating from the threshold value is individually displayed for each monitor attached to the corresponding work facility. The contents of warning differ depending on each work process and warning level. Therefore, in the database 96 constructed by the integrated computer 90, appropriate warnings that match the work process and the work room are stored in advance in a database in accordance with changes in environmental conditions, and the problem occurrence location is stored. Appropriate appropriateness and warning processing are discriminated by the integrated computer 90 to perform safety management.

  The following types of warning data are stored in the database 96. That is, in the database 96, the worker's evacuation route data for each work facility is stored in accordance with the environmental state data level deviating from the threshold value together with the warning, and the integrated computer 90 constituting the alarm means includes: When a warning is issued to the monitor of the work terminal 50 attached to the work room 32 according to the environmental condition that deviates from the threshold, the worker's evacuation route is monitored when the worker needs to be evacuated according to the environmental condition data level. Display and instruct. For example, as shown in FIG. 7, an overhead view of the CPF 10, the current position, and an evacuation route are displayed as an image, and a measure display such as “disaster occurs, promptly move out according to the evacuation route” is displayed on the work terminal 50. To display.

  In addition, the database 96 stores data instructing a method for securing a product being manufactured in each work process for each work facility including a work room in accordance with an environmental state data level that deviates from a threshold value together with a warning. The warning means can display a product securing method on the monitor of the work terminal 50 in the work room 32 in accordance with the environmental condition deviating from the threshold value. For example, in Fig. 8, “Disaster occurs at the time of the occurrence of a disaster according to (i) Dispose of the chemicals in accordance with the disposal procedure. The measure display is displayed on the work terminal 50.

  Further, the database 96 stores data instructing a method for preventing the product from being scattered according to the environmental condition data level that deviates from the threshold value in conjunction with the warning. In addition, it is possible to display a method for preventing product scattering according to an alarm level that requires prevention of product scattering during production. As shown in FIG. 9, matrix data based on the type of the work chamber 32 and the magnitude of deviation from the reference value of the measured pressure, for example, is generated, and other affected areas are dealt with according to the detected deviation. Data describing the procedure may be read out and displayed on the work terminal 50.

  FIG. 10 shows an example in which the contents of measures are stored in a database when a minor fire occurs. As can be understood from this figure, when a fire occurs in the preparation culture chamber 1, a display to that effect is displayed on the work terminal 50 at the occurrence location, and the proximity of the occurrence location to other work chambers. The content of the measures can be adjusted and set, and the content of the measures taken corresponding to the fire level can be read from the database 96 and displayed on each work terminal 50 to be instructed.

  The same applies when data outside the cell processing facility (natural disaster information) is input from the above-described external alarm system unit 85 through the communication line (information network 88), and a warning corresponding to the data outside the facility is stored in the database 96. Warning processing data in each work process of each work room is stored according to the level, and the integrated computer 90 constituting the warning means supports the work process in each work room according to the off-facility data. The warning process to be performed can be individually displayed for each monitor attached to the corresponding work facility.

  As described above, according to the safety management system in the cell processing facility according to the present invention, the information management system unit, the monitoring system unit, the environmental state monitoring unit, and the alarm unit can be used for the corresponding work process of the cell preparation culture operation. Since warning processing corresponding to the environmental state data level that deviates from the corresponding threshold value can be generated, it is possible to appropriately perform safety measures for workers engaged in the CPF 10 and products handled.

10 ......... Cell processing facility (CPF), 12 ......... Material storage room, 13 ......... Preparation room, 12A ......... Freezer, 12B ......... Refrigerator, 14 ...... Reagent preparation room, 14A ... Safety cabinet, 16 ……… Cell preparation room, 16A ……… Safety cabinet, 16B ……… Incubator, 18 ……… Aseptic testing room, 20 ……… Testing and testing room, 22 ……… Freezer storage room, 24… ...... Cleaning and sterilization room, 26 .... Computer management room, 30 .... Safety management system, 32 .... Work room, 34 .... Annular state data, 36 .... Monitoring system section, 38 .... Information Management system section, 40 ......... IC tag, 42 ......... Reading antenna, 44 ......... First computer, 46 ......... Entry / exit management system section, 48 ......... Bar code reader, 50 ......... Working terminal , 52 ......... No. Computer, 54 .... Instruction, 56 .... Production record data, 58 .... Room pressure sensor, 60 .... Room temperature sensor, 62 .... Humidity sensor, 64 .... Airborne particulate sensor, 66 .... ... 3rd computer, 68 ......... Incubator temperature sensor, 70 ......... Floating particle sensor in cabinet, 72 ......... 4th computer, 74 ......... Monitoring camera, 76 ......... 5th computer, 78 ......... Fire detector, 80 ...... Smoke detector, 82 ......... Fire alarm system, 83 ......... Network, 84 ......... Relay panel, 85 ......... External alarm system, 86 ......... Hospital (research facility) ), 88 ......... Information network, 90 ......... Integrated computer, 92 ......... Matrix data, 94 ......... Data sheet, 96 ......... Database, 98 ...... Centralized alarm panel, 1 0 ......... alarm panel, 102 ......... speaker.

Claims (5)

In each process of product manufacture in the cell treatment facility, an information management system unit that manages manufacturing information including workers, work rooms, work dates, equipment used, and manufacturing records in association with product serial numbers;
It has a monitoring system unit that records environmental state data including temperature, humidity, pressure, and cleanliness of work equipment including the work room at an arbitrary fixed time interval.
Generate matrix information consisting of process information from the information management system and environmental status data from the monitoring system in the work facility, and whether the environmental status data obtained by the matrix information is within a certain threshold value. Environmental status monitoring means to be monitored;
An alarm means for issuing a warning according to a deviation between the detected environmental state data and the threshold value when a work facility outside the predetermined threshold value indicating that the environmental state data in the matrix information indicates abnormality is detected;
A database for storing warning processing data corresponding to the environmental state data level deviating from the threshold corresponding to the corresponding work process in advance is provided,
The alarm means acquires a work process in a work facility that deviates from the threshold from the information management system unit, reads warning processing data corresponding to the work process in advance from the database, and deviates from the threshold in conjunction with the warning. A safety management system in a cell processing facility, wherein warning processing including product processing support according to the environmental data level is individually displayed for each monitor attached to the corresponding work facility. The safety management system in the cell treatment facility according to claim 1, wherein the database stores worker evacuation route data for each work facility according to an environmental state data level that deviates from a threshold value together with a warning, The alarm means displays the worker's evacuation route on the monitor when warning is required for the monitor attached to the work room according to the environmental condition outside the threshold when the worker needs to be evacuated according to the environmental condition data level. A safety management system in a cell processing facility, characterized by 2. The safety management system for a cell treatment facility according to claim 1, wherein the database indicates a method for securing a product in production in each work process for each work facility in accordance with an environmental state data level deviating from a threshold value together with a warning. A safety management system in a cell processing facility, wherein the warning means is capable of displaying a product securing method on a monitor in a work room according to an environmental condition that deviates from a threshold value. The safety management system in the cell treatment facility according to claim 1, wherein the database stores data instructing a method for preventing a product from being scattered according to an environmental state data level deviating from the threshold in conjunction with a warning. A safety management system in a cell treatment facility, which can display a method for preventing product scattering according to an alarm level that requires prevention of product scattering during production on a monitor in a work room according to a detached environmental condition . 2. The safety management system for a cell processing facility according to claim 1, wherein the monitoring system unit can input data from an external alarm system unit outside the cell processing facility through a communication line, and the database corresponds to the data outside the facility. The warning processing data in each work process of each work room is stored according to the warning level, and the warning means performs the warning process corresponding to the work process in each work room according to the off-facility data. A safety management system in a cell processing facility, wherein each monitor attached to the equipment is individually displayed.