JP7485845B1 - Manufacturing process management system and manufacturing process management method - Google Patents

Abstract

[Problem] To provide a manufacturing process management system that supports recovery from delays that occur in the progress of a manufacturing process in a manufacturing facility for pharmaceuticals, etc. [Solution] The system includes a PLC 10 that executes a control program 30, a memory 12 that stores a standard process that defines steps and standard required times between steps, and correction data, an audit trail recording means 40 that records an audit trail including the required time of each step and process parameters, a delay determination means 50 that determines that a delay has occurred if the required time of a step recorded by the audit trail recording means is longer than the standard required time, and a delay recovery proposal means 60 that, when it is determined that a delay has occurred by the delay determination means 50, searches the correction data for process parameters and required times of steps to be executed in the future and outputs them to a touch panel 20 so that the manufacturing process will end before the end time of the last step of the standard process. [Selected Figure] Figure 2

Description

The present invention relates to a manufacturing process management system and a manufacturing process management method that can manage manufacturing processes carried out in a pharmaceutical manufacturing facility.

Pharmaceutical manufacturing facilities are equipped with processing equipment for various processing purposes, sensors that collect operating data for the processing equipment, and control devices to control the processing equipment. The control devices run control programs to operate the various processing equipment and manufacture the desired pharmaceuticals.

The control program consists of a number of steps for implementing the manufacturing process, some of which are designed to proceed to the next step by an operator's operation. For example, the control program progresses each step for implementing the manufacturing process (a step for feeding raw materials, a step for heating the raw materials, a step for stirring, a step for cooling, etc.) as follows:
Raw material input process Step 1: Information to input raw materials into a tank (an example of a processing device) is displayed on an input/output device such as a touch panel.
Raw material input process Step 2: When the worker has actually finished inputting the raw materials, GUI components such as buttons to be pressed are displayed on the input/output device.
Raw material input process Step 3: When the worker presses the button, the raw material input process ends and the process moves on to the next mixing process.

Each step may involve automatic control of the processing equipment by a control device, or may involve manual work by an operator (e.g., adding raw materials) and touch panel operations to proceed to the next step after completing that work. Although the manufacturing process is expected to be completed at a set time according to a defined standard process, delays in the progress of steps may occur due to human factors.

For example, Patent Document 1 proposes an analysis method for calculating delay times for standard processes, but it is not intended to recover from delays at the manufacturing site. It is desirable to be able to recover from delays at the manufacturing site in order to adhere to production plans.

JP 2021-174541 A

In view of the above circumstances, an object of the present invention is to provide a manufacturing process management system and a manufacturing process management method that assist in recovering from delays that occur in the progress of a manufacturing process in a pharmaceutical manufacturing facility.

A mode for achieving the above object includes a processing device for manufacturing pharmaceuticals , an input/output device, a control device for executing a control program for causing the processing device to realize a manufacturing process consisting of a plurality of steps, the control device being capable of advancing the step to the next step by an operation by an operator via the input/output device, a storage device storing a standard process that defines the steps and standard required times between steps, and correction data that defines process parameters for controlling the processing device, the process parameters including at least the required time for the step, for each of the steps, an audit trail recording means that records an audit trail including the required time for each of the steps and the process parameters, and the required times for the steps recorded by the audit trail recording means. and a delay recovery proposal means for, when it is determined by the delay determination means that a delay has occurred, searching for process parameters and required times of a step to be executed in the future from the correction data and outputting the process parameters and required times to the input/output device so that the manufacturing process will end before the end time of the last step of the standard process, wherein the correction data are the process parameters included in the audit trail of a manufacturing process executed in the past, and are approved as having been manufactured in accordance with a predetermined standard, and the predetermined standard is a combination of the process parameters and properties of a drug that have been proven to ensure the quality of the drug .

According to the present invention, a manufacturing process management system and a manufacturing process management method are provided that assist in recovering from a delay that occurs in the progress of a manufacturing process in a pharmaceutical manufacturing facility.

FIG. 1 is a schematic configuration diagram of a manufacturing process management system. FIG. 2 is a block diagram showing the functions of a manufacturing process management system. FIG. 4 illustrates an example of a control program. FIG. 13 illustrates an example of an audit trail. FIG. 1 is a diagram for explaining a procedure for proposing delay recovery. FIG. 13 illustrates an example of an audit trail. FIG. 1 shows an example of a design space.

Figure 1 is a schematic diagram of a manufacturing process management system 1. The management system 1 of this embodiment targets a facility that manufactures pharmaceuticals. The facility is composed of various processing devices for manufacturing pharmaceuticals and a measuring device that measures operating data from the processing devices.

Tank 2 is a device that receives raw materials from an inlet of tank 2 and stores the raw materials inside. Tank 2 is provided with or connected to various devices such as a stirring device 3, a temperature adjustment device 4, and a liquid delivery device 5. Tank 2, stirring device 3, temperature adjustment device 4, and liquid delivery device 5 are examples of processing devices, and are collectively referred to as processing devices 2 to 5. Tank 2 is provided with a jacket (not shown), and the inside of tank 2 is set to the desired temperature by a heat medium supplied into the jacket.

The agitator 3 rotates a screw disposed inside the tank 2 to agitate the raw materials. The agitator 3 is given the rotation speed and rotation time of the screw when agitating the raw materials inside the tank 2 as a control signal from the PLC 10. The agitator 3 is configured to receive the control signal and agitate the raw materials inside the tank 2 at the set rotation speed and rotation time. Information from the agitator 3, such as the actual rotation speed and the time elapsed since rotation began, is also sent to the PLC 10, and the PLC 10 is able to read this information.

The temperature adjustment device 4 is a device for adjusting the temperature of the raw materials stored inside the tank 2. The temperature adjustment device 4 is a known device composed of a heat exchanger for adjusting the heat medium to the desired temperature, a liquid delivery means such as a pump for supplying the heat medium to the jacket of the tank 2, etc. The temperature adjustment device 4 heats or cools a heat medium such as water to the temperature set by the PLC 10, and delivers the heat medium to the jacket of the tank 2, thereby making the temperature of the raw materials stored in the tank 2 the same as that of the heat medium.

The liquid delivery device 5 is a device for transferring the raw material stored in the tank 2 to another processing device (not shown). For example, it is a pump that supplies compressed air into the tank 2, and a valve installed in the piping through which the air flows. The liquid delivery device 5 is given the pump output, valve opening, etc. as control signals from the PLC 10. The liquid delivery device 5 is configured to receive the control signal, operate the pump at the set output, and open the valve at the set opening.

The temperature sensor 6 and the weighing device 7 are examples of measuring devices, and other measuring devices that measure properties of raw materials (including raw materials in the manufacturing process and products after manufacturing is completed), such as turbidity, concentration, pH, etc., are collectively referred to as measuring devices 6-7, although they are not specifically shown. The measuring devices 6-7 may directly measure the raw materials in the tank 2 or piping, or may measure samples taken from the tank 2 or piping. The temperature sensor 6 measures the temperature of the raw materials stored inside the tank 2. In other words, it is configured to measure the temperature of the raw materials inside the tank 2 and transmit the temperature to the PLC 10. The weighing device 7 measures the raw materials stored inside. In other words, it is configured to measure the weight of the raw materials inside the tank 2 and transmit the weight to the PLC 10.

The raw materials are mixed in tank 2 by the operation of these processing devices 2 to 5, and the raw materials are then subjected to the specified processing in other processing devices (not shown), so that pharmaceuticals are manufactured by the entire facility.

As shown in FIG. 2, the management system 1 includes a PLC 10, which is a control device for equipment including the processing devices 2-5 and various measuring devices 6-7. A touch panel 20 is connected to the PLC 10 as an input/output device.

The PLC 10 is a device also called a programmable controller or sequencer. The PLC 10 includes a CPU 11 and a memory 12, and controls the processing devices 2 to 5 by reading and executing a control program 30 stored in the memory. The control program 30 reads setting values for controlling the processing devices 2 to 5 from the memory 12, and controls the processing devices 2 to 5 to operate according to the setting values. Hereinafter, the setting values are referred to as process parameters. The process parameters include at least the time for operating the processing devices 2 to 5 (the time required for a step). The memory 12 is an example of a storage device in the claims.

The touch panel 20 is connected to the PLC 10, and displays a predetermined screen and detects operations by an operator. Specifically, the touch panel 20 includes a CPU 21, an input/output unit 22, and a memory 23. The touch panel 20 can be connected to the PLC 10 via a network.

The touch panel 20 is capable of sending and receiving data to and from the PLC 10. The PLC 10 is capable of displaying a screen on each touch panel 20, and each touch panel 20 is capable of sending to the PLC 10 data such as the operation of a GUI component such as a button, and data such as characters and numbers generated by operating a GUI component.

Specifically, the input/output unit 22 is composed of a display device and a detection mechanism for detecting an operation of touching the surface of the display device. The display device may be a known display device such as a liquid crystal panel or an organic electroluminescence (EL) display. The detection mechanism may be a known type such as a resistive film type or a capacitive type.

The memory 23 stores a program for operating the touch panel 20, and the CPU 21 calls up and executes this program from the memory 23. The touch panel 20 is also capable of reading and writing to the memory 12 of the PLC 10. This makes it possible for the program of the touch panel 20 to display process parameters stored in the PLC 10 on the input/output unit 22, and to write new process parameters that have been changed based on the operation of the input/output unit 22 to the memory 12 of the PLC 10.

The memory 12 of the PLC 10 also stores a control program 30, an audit trail recording means 40, a delay determination means 50, a delay recovery proposal means 60, a standard process 70, and correction data 80.

An example of a control program is shown in Figure 3. The control program 30 is a program for operating the processing devices 2 to 5 to manufacture products. The control program 30 is written in a language such as ladder circuitry. The control program 30 is made up of multiple steps and is executed sequentially, but some steps can be advanced to the next step by an operator's operation on the touch panel 20. The step that advances to the next step upon such an operator operation is called a confirmation step.

Steps [1] to [3] are steps for implementing one manufacturing process called the "raw material input process."
Step [1]: Information encouraging the input of raw materials is displayed on the touch panel 20. The worker looks at the information and actually inputs the raw materials into the tank 2.

Step [2]: This is a step for confirming the weight of the raw materials put into tank 2. Specifically, control program 30 displays on touch panel 20 a screen showing the weight of the raw materials put into tank 2 obtained by weighing device 7, a button to be pressed if the weight is as specified, and the like. When the button is pressed by the worker, control program 30 proceeds to the next step [3]. Step [2] is one of the confirmation steps that proceeds to the next step [3] if an operator operates it.

Step [3]: This step confirms that the introduction of raw materials has been completed. Specifically, the control program 30 displays on the touch panel 20 a screen that displays a button to be pressed when the introduction of raw materials has been completed. When the button is pressed by the operator, the control program 30 proceeds to the next step [4]. Step [3] is one of the confirmation steps.

Steps [4] to [6] are steps for implementing one manufacturing process called the "heating process."
Step [4]: This is a step for confirming the process parameters used in the heating process. Specifically, the control program 30 displays on the touch panel 20 a screen on which the process parameters used in the heating process, such as the target temperature and holding time for heating, and a button for starting heating, are arranged. When the button is pressed by the operator, the control program 30 proceeds to the next step [5]. Step [4] is one of the confirmation steps.

Step [5]: This is a step in which the temperature control device 4 heats the raw material in the tank 2 to a predetermined temperature. Specifically, the temperature control device 4 is operated by executing a predetermined command based on the process parameters.

Step [6]: This is a step for determining whether heating is complete. Specifically, the control program 30 determines that heating is complete when a predetermined condition is met after heating has started. The predetermined condition is, for example, the time since heating started, or whether the temperature of the raw material in the tank 2 measured by the temperature sensor 6 has reached a predetermined temperature. When heating is complete, the process proceeds to the next step [7]. This type of step is not a confirmation step, because the process proceeds to the next step regardless of the operator's operation on the touch panel 20.

Steps [7] to [9] are steps for implementing one manufacturing process called the "mixing process."
Step [7]: This is a step for confirming process parameters related to mixing, such as the number of revolutions (rpm) of the mixer 3 and the mixing time. Specifically, a screen is displayed on the touch panel 20 that displays the process parameters related to mixing and a button to be pressed if the process parameters are as specified. When the button is pressed by the operator, the control program 30 proceeds to the next step [7]. Step [6] is one of the confirmation steps that proceeds to the next step [7] if an operator operates the step.

Step [8]: This step causes the agitator 3 to agitate the contents of the tank 2. Specifically, the agitator 3 is operated by executing a predetermined command based on the process parameters.

Step [9]: This step confirms that mixing has been completed. Specifically, the control program 30 displays on the touch panel 20 a screen with a button to be pressed once mixing has been completed. The worker checks the state of the ingredients after mixing, for example by visual inspection, and presses the button. When the worker presses the button, the control program 30 proceeds to the next step [10]. Step [9] is one of the confirmation steps.

Steps [10] to [12] are steps for realizing a manufacturing process called the "cooling process."

Step [10]: This is a step for confirming the process parameters to be used in the cooling process. Specifically, the control program 30 displays on the touch panel 20 a screen that displays the process parameters to be used in the cooling process, such as the target temperature and holding time for cooling, and a button for starting cooling. When the button is pressed by the operator, the control program 30 proceeds to the next step [11]. Step [10] is one of the confirmation steps.

Step [11]: This step causes the temperature control device 4 to cool the raw material in the tank 2 to a predetermined temperature. Specifically, the temperature control device 4 is operated by executing a predetermined command based on the process parameters.

Step [12]: This step determines whether cooling is complete. Specifically, the control program 30 determines that cooling is complete when a predetermined condition is met after cooling has started. The predetermined condition is, for example, the time since cooling started, or whether the temperature of the raw material in the tank 2 measured by the temperature sensor 7 has reached a predetermined temperature. When cooling is complete, the process proceeds to the next step [13]. This type of step is not a confirmation step, because the process proceeds to the next step without the operator's operation on the touch panel 20.

Steps [13] and [14] are steps for implementing one manufacturing process called the "transfer process."
Step [13]: This is a step of controlling the liquid delivery device 5 to transfer the raw material in the tank 2 to another processing device.

Step [14]: This step determines whether the transfer is complete. Specifically, the control program 30 determines that the transfer is complete when a predetermined condition is met after the transfer has started. The predetermined condition may be, for example, the time since the transfer started, or whether the weight of the raw material in the tank 2 measured by the weighing device 7 has become zero. This type of step is not a confirmation step, because the next step is proceeded to without the operator's operation on the touch panel 20. When the transfer is complete, the series of manufacturing processes in the tank 2 ends.

A standard process is data that defines the standard time required for each step and between steps. The standard time required for a step is the standard time required for a step. For example, the standard time is set to be longer than the time required to ensure the quality of pharmaceuticals, etc. at the minimum. The standard time required between steps is the time between successive steps. The standard time is determined appropriately taking into consideration the time required for worker actions and the state of the PLC 10 and processing devices 2 to 5.

The correction data is the process parameters for controlling the processing devices 2 to 5, and includes at least the time required for each step, defined for each step. The correction data, which will be described in detail later, is used to correct the start time and process parameters of each step when the manufacturing process is predicted to be delayed beyond the end time of the standard process.

We will now explain the audit trail recording means 40, delay determination means 50, and delay recovery proposal means 60. Each of these means is intended to realize various functions implemented as programs executed by the PLC 10.

The audit trail recording means 40 obtains operation data from the measuring devices 6-7, records it in memory 12 together with the time of acquisition, and records the work data performed by the worker in memory 12. The audit trail is composed of the operation data of the processing devices 2-5 and work data showing the execution status of steps.

The operating data is data obtained from the measuring devices 6-7, and data obtained by processing the data. The latter is, for example, the slope of measured values such as temperature over time, and the rate of change. The PLC 10 executes the control program described above to operate the processing devices 2-5 and manufacture pharmaceuticals, and during this time, the measuring devices 6-7 obtain operating data such as the weight and temperature of the raw materials in the tank 2, and measurements related to the properties of the raw materials.

The work data is data that represents the execution status of the steps that make up the manufacturing process. Specifically, it includes the time required for each step, as well as the start and end times, and process parameters for controlling the processing devices 2 to 5. For steps that require operator operation, the work data also includes data identifying the operator who performed the work. In principle, the process parameters are preset in the memory 12, but they may also be set by an operator via operation of the touch panel 20 and stored in the memory 12.

Figure 4 shows an example of work data in an audit trail. Each row represents work data that is an audit trail. The audit trail in the Nth row is denoted as audit trail [N].

Audit trail [1] indicates that step 1 was executed by PLC 10, and that the work data, including the start and end times of that step (the required time is calculated from these), was recorded as an audit trail. Similarly, audit trails [2]-[14] also record that each step was executed, and the start and end times.

Audit trail [2] represents the work data related to step 2. After worker A adds raw materials, he checks the weight of the raw materials in tank 2, and when he performs the operation of checking the weight on touch panel 20, the process proceeds from step 2 to step 3. Audit trail recording means 40 records "worker A" who added raw materials. "Worker A" is an example of information that identifies a worker, and is information that can be obtained by authenticating the worker prior to operating touch panel 20. In this way, audit trail [2] represents that "worker A" performed work on "tank 2" (adding raw materials and checking the weight), and performed an operation on "touch panel 20" to proceed to the next step 3.

Audit trail [3] represents the work data related to step 3. When Worker A performs an operation on the touch panel 20 indicating that he has completed the loading of raw materials, the process proceeds from step 3 to step 4. At this time, the audit trail recording means 40 records "Worker A" who loaded the raw materials. In other words, audit trail [3] represents that "Worker A" performed work on "Tank 2" (completion of raw material loading) and performed an operation on "Touch panel 20" to proceed to the next step 4.

Audit trail [4] represents the work data related to step 4. When Worker A performs an operation on the touch panel 20 to confirm the process parameters for heating, the process proceeds from step 4 to step 5. At this time, the audit trail recording means 40 records "Worker A" who confirmed the process parameters. In other words, audit trail [4] represents that "Worker A" performed work on "Tank 2" (confirmed the process parameters) and performed an operation on the "Touch Panel 20" to proceed to the next step, 5.

Audit trail [5] represents the work data related to step 5. PLC 10 executes step 5 to heat the raw materials inside tank 2, and audit trail recording means 40 records the process parameters used at this time as the audit trail. In the example of audit trail [5], the temperature of the heat transfer medium, "65°C", and the time to heat at that temperature, "10 minutes", are recorded as the audit trail.

Audit trail [6] represents the work data related to step 6. When Worker A performs an operation on the touch panel 20 to confirm that heating is complete, the process proceeds from step 6 to step 7. At this time, the audit trail recording means 40 records "Worker A" who confirmed that heating is complete. In other words, audit trail [6] represents that "Worker A" performed work on "Tank 2" (confirmed that heating was complete) and performed an operation on "Touch panel 20" to proceed to the next step 7.

Audit trail [7] represents the work data related to step 7. When Worker A performs an operation on the touch panel 20 to confirm the process parameters for heating, the process proceeds from step 7 to step 8. At this time, the audit trail recording means 40 records "Worker A" who confirmed the process parameters. In other words, audit trail [7] represents that "Worker A" performed work on "Tank 2" (confirmed the process parameters) and performed an operation on the "Touch Panel 20" to proceed to the next step 8.

Audit trail [8] represents the work data related to step 8. The PLC 10 executes step 8 to mix the raw materials inside the tank 2, and the audit trail recording means 40 records the process parameters used at this time as the audit trail. In the example of audit trail [8], the rotation speed of the mixer 3, "300 rpm", and the time taken for mixing, "5 minutes", are recorded as the audit trail.

Audit trail [9] represents the work data related to step 9. When Worker A performs an operation on the touch panel 20 to confirm that mixing is complete, the process proceeds from step 9 to step 10. At this time, the audit trail recording means 40 records "Worker A" who confirmed that mixing is complete. In other words, audit trail [9] represents that "Worker A" performed work on "Tank 2" (confirmed that mixing was complete) and performed an operation on the "Touch Panel 20" to proceed to the next step 10.

Audit trail [10] represents the work data related to step 10. When Worker A performs an operation on the touch panel 20 to confirm the process parameters for cooling, the process proceeds from step 10 to step 11. At this time, the audit trail recording means 40 records "Worker A" who confirmed the process parameters. In other words, audit trail [10] represents that "Worker A" performed work on "Tank 2" (confirmed the process parameters) and performed an operation on the "Touch Panel 20" to proceed to the next step 11.

Audit trail [11] represents the work data related to step 11. PLC 10 executes step 5 to cool the raw materials inside tank 2, and audit trail recording means 40 records the process parameters used at this time as the audit trail. In the example of audit trail [11], the temperature of the heat transfer medium, "20°C", and the time to cool at that temperature, "10 minutes", are recorded as the audit trail.

Audit trail [12] represents the work data related to step 12. When Worker A performs an operation on the touch panel 20 to confirm that cooling is complete, the process proceeds from step 12 to step 7. At this time, the audit trail recording means 40 records that "Worker A" confirmed that cooling is complete. In other words, audit trail [12] represents that "Worker A" performed work on "Tank 2" (confirmed that cooling was complete) and performed an operation on the "touch panel 20" to proceed to the next step 13.

Audit trail [13] represents the work data related to step 13. PLC 10 executes step 13 to transfer the raw material inside tank 2, and audit trail recording means 40 records the fact that the transfer occurred, as well as the start and end times, as an audit trail.

Audit trail [14] represents the work data related to step 14. When Worker A performs an operation on the touch panel 20 to confirm that the transfer is complete, step 14 ends. At this time, the audit trail recording means 40 records "Worker A" who confirmed the transfer completion, the start time, and the end time.

The delay determination means 50 determines that a delay has occurred if the time required for a step recorded by the audit trail recording means 40 is longer than the standard time required for the standard process. For example, assume that execution of step 1 of the raw material input process has been completed. At this time, the delay determination means 50 determines that a delay has occurred if the time required for the audit trail [1] shown in Figure 4 (8 minutes) is longer than the standard time required for step 3 in the standard process.

The delay determination means 50 may determine a delay not only for the time required for one step as described above, but also for the time required for multiple steps. For example, since steps 1-3 are steps in the raw material input process, the time required for these steps 1-3 may be compared with the standard time required for the standard process to determine a delay. In addition, although it is preferable to determine a delay after the completion of each step, it is not limited to this timing and can be performed at any timing during the manufacturing process.

When the delay determination means 50 determines that a delay has occurred, the delay recovery suggestion means 60 searches the correction data for process parameters and required times for future steps to be executed, and outputs them to the touch panel 20 so that the manufacturing process will end before the end time of the last step of the standard process. The end time of the last step of the standard process is called the standard end time. The standard end time can be obtained by adding the start time of the first step executed by the PLC 10 to the required time of the entire standard process. The required time of the entire standard process is the sum of the standard required times for each step of the standard process and the standard required times between steps.

The procedure for proposing delay recovery will be explained using Figure 5. Figure 5(a) shows the standard process. The standard time required for the raw material receiving process (steps 1-3) is 10 minutes, the standard time required for the heating process (steps 4-6) is 10 minutes, the standard time required for the mixing process (steps 7-9) is 5 minutes, the standard time required for the cooling process (steps 10-12) is 10 minutes, and the standard time required for the transfer process (steps 13-14) is 5 minutes.

As shown in FIG. 5(b), assume that a three-minute delay occurs in the raw material receiving process. In this case, the delay determination means 50 determines that the final transfer process will end after the standard end time, i.e., a delay will occur.

As shown in FIG. 5(c), the delay recovery proposal means 60 searches for correction data for processes after the raw material receiving process that are at least 3 minutes shorter than the standard process time. Table 1 shows an example of correction data. The correction data in the Nth row is written as correction data [N].

For example, the required times for correction data [2], correction data [4], and correction data [6] are each one minute shorter than the standard required time for the standard process, for a total of three minutes shorter. The delay recovery proposal means 60 searches for such correction data and outputs the process parameters along with the required times to the touch panel 20. As shown in FIG. 5(c), a three-minute delay occurred in the raw material receiving process, but the required times for the subsequent heating process (step 5), mixing process (step 8), and cooling process (step 11) were reduced, so that the final transfer process was completed in time for the standard end time.

The worker can recover from the delay by checking the suggestions displayed on the touch panel 20, changing the process parameters, and then proceeding with the step. For example, when checking the process parameters for steps 4, 7, and 10, the worker can reset them to the suggested process parameters and proceed with the step.

In the above example, three correction data were searched for to propose process parameters that can recover the delay, but the present invention is not limited to searching for multiple correction data. A single correction data may be searched for to recover the delay. For example, the required time for correction data [3] is two minutes, which is three minutes shorter than the corresponding standard required time. Therefore, a proposal may be made to select one of the correction data [3] to recover the delay.

The correction data can be determined arbitrarily, but it is preferable to use process parameters included in the audit trail of manufacturing processes previously carried out, and that have been approved as having been manufactured in accordance with prescribed standards for pharmaceuticals, etc.

Specifically, information that is true if the quality control department or other department determines that the quality of the manufactured pharmaceutical products and the process parameters used in their manufacture meet specified standards, and false if not, is associated with the audit trail (process parameters).

For example, suppose there is an audit trail as shown in Figure 6. Each line of the audit trail in Figure 6 (hereinafter referred to as audit trail [A], audit trail [B], and audit trail [C]) is a simplified representation of the process parameters extracted from the audit trail for the series of manufacturing processes shown in Figure 4. In the example shown, audit trails are shown for three manufacturing processes that have been carried out in the past. Information is also added to each audit trail indicating whether or not it has been approved by the quality control department, etc.

The delay recovery proposal means 60 uses such audit trails as new correction data. Specifically, it extracts only approved audit trails and searches for those that can be used to recover from the delay. In the example of Figure 6, audit trail [A] and audit trail [B] become the correction data.

This kind of correction data is derived from audit trails where process parameters have been proven to work in the past, so it is possible to make proposals that can recover from delays and ensure the quality of pharmaceuticals, etc.

In addition, it is preferable that the specified criteria used in the correction data are within the range of the design space. A design space is a combination of process parameters and properties of a drug or other product that have been proven to ensure the quality of the drug, beverage, or food. In other words, even if the process parameters are different, the quality of the drug or other product obtained by the steps performed with those process parameters is guaranteed to be the same.

For example, a value that represents the properties of a drug or the like and is used to determine whether the drug or the like is appropriate (hereinafter referred to as a target value) is set to Y. This target value Y can be measured by the measuring devices 6 to 7. A model formula for this target value Y is created.
[Equation 1]
Y = f (X1, X2, ..., Xn)

The model formula has the properties of the pharmaceutical product and process parameters as variables, and at least one of the variables is the required time, which is one of the process parameters. The pharmaceutical product is manufactured experimentally in advance, and such model formula f is created. The properties of the pharmaceutical product can be obtained by sampling or the like using various measuring devices 6-7, and the process parameters applied are those used in each step of the pharmaceutical product manufacturing process. Data on the target values, properties, and process parameters of the pharmaceutical product can be collected experimentally in this way, and the model formula f can be created using known analytical methods.

Figure 7 shows an example of a design space for a two-variable model formula. In this figure, the axes are the required time and temperature, and the rectangle indicates the range of the design space. The two variables are, for example, two process parameters related to heating, temperature and required time. The target value Y is calculated from the model formula using a combination of these process parameters as variables. If the target value Y is appropriate for the quality of a drug, etc., the variable corresponding to that target value Y is within the range of the design space. The design space is a combination of variables that allows the manufacture of drugs, etc. of appropriate quality. In other words, if the process parameters or properties are different within the range of the design space, they are not considered to have been substantially changed. In the example shown in this figure, if the temperature and required time are selected within the range of the design space indicated by the hatched rectangle, they are within the range in which the quality of the drug, etc. can be considered to be appropriate.

In the illustrated example, there are two variables, but the design space can also be defined using a model formula that includes multiple variables, such as other process parameters (e.g., rotation speed [rpm] and time required for stirring) and properties of pharmaceuticals, etc. (e.g., concentration, pH, and changes in these variables over time).

The quality control department determines whether the process parameters (time required, temperature) of the audit trail of previously performed manufacturing processes and the properties of the pharmaceutical products manufactured in that manufacturing process are within the range of the design space, and if so, approves the audit trail as the pharmaceutical products have been manufactured to meet the specified standards.

Because such correction data is based on a design space in which the process parameters guarantee the quality of pharmaceutical products, it is possible to propose a method for restoring delays while ensuring the quality of pharmaceutical products. In particular, in the pharmaceutical field, it has traditionally been common to use process parameters that have been approved in advance. However, the idea of design space has recently become widespread, whereby changing the combination of process parameters and input variables (such as the properties of raw materials) is not considered a change as long as it is within a range that ensures the quality of pharmaceutical products. In this invention, the required time adopted as a process parameter is used as correction data that is appropriately set within the range of the design space. This makes it possible to propose process parameters that can restore delays while ensuring the quality of pharmaceutical products.

As described above, the management system 1 of this embodiment records the equipment audit trail and, if a delay occurs in the manufacturing process, can suggest process parameters to restore the delay.

The management system 1 of this embodiment proposes process parameters to recover from delays using correction data based on audit trails. Because the process parameters are derived from audit trails with past operational records, it is possible to recover from delays and ensure the quality of pharmaceuticals, etc.

The management system 1 of this embodiment proposes process parameters to recover from the delay using correction data based on the design space. Because the process parameters are within the range of the design space that ensures the quality of the drug, it is possible to make proposals that can recover from the delay and ensure the quality of the drug, etc.

In each of the above-mentioned embodiments, a management system for a pharmaceutical manufacturing facility has been described, but the present invention is not limited to this and can also be applied to facilities that manufacture food and beverages.

The touch panel 20 is an example of an input/output device in the claims, but is not limited to this. Any device that can be connected to the PLC 10 and is capable of inputting and outputting data may be used, and a keyboard, mouse, etc. may be separate from an input device, such as a display, as an output device.

The audit trail recording means 40 of this embodiment is executed by the PLC 10 and records the audit trail in the memory 12 of the PLC 10, but is not limited to this form. For example, instead of recording the audit trail in the memory 12, it may be transmitted to a general personal computer or the like via a communication means, and the audit trail may be recorded on the personal computer. Alternatively, the audit trail recording means 40 may be a general personal computer program, and may be configured to obtain a measurement personal computer using a communication means, obtain operation data from the PLC 10, and record them as an audit trail. Similarly, the delay determination means 50 and the delay recovery proposal means 60 may also be programs executed by a personal computer or the like, rather than the PLC 10, and the proposed process parameters, etc. may be transmitted to the PLC 10 using a communication means and displayed on the touch panel 20.

The manufacturing process management method according to the present invention will be described. The manufacturing process management method executes the following first to fourth steps in a facility that includes processing equipment 2 to 5 that manufactures pharmaceuticals, beverages, or food, a touch panel 20, and a PLC 10 that executes a control program 30 that causes the processing equipment to execute a manufacturing process consisting of multiple steps, and that allows an operator to proceed to the next step by operating the touch panel 20.

In the first step, a standard process and correction data are created. As described above, the standard process is set appropriately according to the pharmaceutical product to be manufactured, and is stored in memory 12.

Correction data is created as follows: First, the development department etc. experimentally creates the range of the design space of the drug etc., and sets it as the specified standard.

Next, the quality assurance department or the like verifies whether the process parameters included in the audit trail for the manufacturing process previously performed meet the specified criteria (within the range of the design space). Note that this verification does not have to be done by the quality assurance department or the like, and the PLC 10 or a general computer may be used to verify whether the process parameters meet the specified criteria. If the process parameters meet the specified criteria, the quality of the pharmaceutical product or the like is guaranteed, so the quality assurance department or the like adds information to the effect that they approve the audit trail, creates correction data, and stores the correction data in memory 12.

In the second step, the PLC 10 (audit trail recording means 40) records an audit trail including the duration of each step and the process parameters.

In the third step, the PLC 10 (delay determination means 50) determines that a delay has occurred if the required time for the step recorded in the second step is longer than the standard required time.

In the fourth step, when the PLC 10 (delay recovery proposal means 60) determines that a delay has occurred in the third step, it searches the correction data for the process parameters and required time of a step to be executed in the future, and outputs the process parameters and required time to the input/output device so that the manufacturing process ends before the end time of the last step of the standard process.

This manufacturing process management method can propose process parameters to recover from delays using correction data based on the audit trail. Because the process parameters are derived from audit trails with a proven track record of operation in the past, it is possible to recover from delays and ensure the quality of pharmaceutical products, etc. In particular, because the process parameters are within the range of the design space in which the quality of pharmaceutical products is guaranteed, proposals can be made that can recover from delays and ensure the quality of pharmaceutical products, etc.

1...Management system, 10...PLC (control device), 20...Touch panel, 30...Control program, 40...Audit trail recording means, 50...Delay determination means, 60...Delay recovery proposal means

Claims (2)

A processing device for producing pharmaceutical products ;
An input/output device;
a control device that executes a control program for causing the processing device to realize a manufacturing process consisting of a plurality of steps, the control device being capable of advancing the step to the next step by an operation by an operator via the input/output device;
a storage device that stores a standard process that defines the steps and standard required times between steps, and correction data that defines process parameters for controlling the processing device, the process parameters including at least the required times for the steps, for each of the steps;
an audit trail recording means for recording an audit trail including the duration of each of said steps and said process parameters;
a delay determination means for determining that a delay has occurred if the required time of the step recorded by the audit trail recording means is longer than the standard required time;
a delay recovery suggestion means for searching the correction data for process parameters and required times of future steps to be executed and outputting the process parameters and required times to the input/output device when the delay determination means determines that a delay has occurred, so that the manufacturing process will be completed before the end time of the last step of the standard process;
Equipped with
the calibration data being the process parameters included in the audit trail for previously performed manufacturing processes that have been approved as having been manufactured to a prescribed standard for a pharmaceutical product;
The predetermined criteria are a combination of drug properties and process parameters that have been proven to ensure drug quality.
A manufacturing process management system comprising: A method for managing a manufacturing process executed in equipment including a processing device for manufacturing a pharmaceutical product , an input/output device, and a control device for executing a control program for causing the processing device to realize a manufacturing process consisting of a plurality of steps, the control program enabling an operator to proceed to the next step through an operation performed by the input/output device, comprising:
a first step of creating correction data for each of the steps, the correction data defining a standard process that defines the steps and standard required times between steps, and process parameters for controlling the processing device, the process parameters including at least the required time for each step;
a second step of recording an audit trail including the duration of each of said steps and said process parameters;
a third step of determining that a delay has occurred if the required time of the step recorded in the second step is longer than the standard required time;
a fourth step of retrieving a process parameter and a required time of a step to be executed in the future from the correction data and outputting the process parameter and the required time of a step to be executed in the future to the input/output device when it is determined that a delay has occurred in the third step, so that the manufacturing process will be completed before the end time of the last step of the standard process;
In the first step,
A combination of the properties of the pharmaceutical product that have been proven to ensure quality and the process parameters is prepared in advance as a predetermined standard;
creating said correction data for said process parameters included in said audit trail for previously performed manufacturing processes that have been approved as having been manufactured in accordance with said predetermined criteria.

Images