CN117250923A - Process, production and equipment operation linkage control method for pharmaceutical production line - Google Patents
Process, production and equipment operation linkage control method for pharmaceutical production line Download PDFInfo
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 161
- 238000000034 method Methods 0.000 title claims abstract description 129
- 230000008569 process Effects 0.000 title claims abstract description 91
- 238000010923 batch production Methods 0.000 claims abstract description 59
- 239000003814 drug Substances 0.000 claims abstract description 13
- 230000000694 effects Effects 0.000 claims abstract description 12
- 229940079593 drug Drugs 0.000 claims abstract description 5
- 239000000463 material Substances 0.000 claims description 82
- 238000007726 management method Methods 0.000 claims description 49
- 238000004140 cleaning Methods 0.000 claims description 36
- 238000012790 confirmation Methods 0.000 claims description 36
- 238000002156 mixing Methods 0.000 claims description 22
- 238000002360 preparation method Methods 0.000 claims description 20
- 230000007306 turnover Effects 0.000 claims description 15
- 238000005303 weighing Methods 0.000 claims description 12
- 238000012544 monitoring process Methods 0.000 claims description 8
- 238000011194 good manufacturing practice Methods 0.000 claims description 6
- 238000005469 granulation Methods 0.000 claims description 6
- 230000003179 granulation Effects 0.000 claims description 6
- 238000013474 audit trail Methods 0.000 claims description 4
- 238000004364 calculation method Methods 0.000 claims description 3
- 230000003749 cleanliness Effects 0.000 claims description 3
- 238000001035 drying Methods 0.000 claims description 3
- 238000007689 inspection Methods 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 239000000843 powder Substances 0.000 claims description 3
- 238000004064 recycling Methods 0.000 claims description 3
- 238000005070 sampling Methods 0.000 claims description 3
- 238000003860 storage Methods 0.000 claims description 3
- 210000001503 joint Anatomy 0.000 claims description 2
- 229940126680 traditional chinese medicines Drugs 0.000 abstract description 2
- 238000005550 wet granulation Methods 0.000 description 6
- 238000010586 diagram Methods 0.000 description 5
- 238000012545 processing Methods 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 230000002159 abnormal effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000004075 alteration Effects 0.000 description 1
- 238000012550 audit Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000009835 boiling Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 238000010924 continuous production Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000004886 process control Methods 0.000 description 1
- 238000011112 process operation Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000005728 strengthening Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B19/00—Programme-control systems
- G05B19/02—Programme-control systems electric
- G05B19/418—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM]
- G05B19/41865—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM] characterised by job scheduling, process planning, material flow
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- G—PHYSICS
- G05—CONTROLLING; REGULATING
- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B2219/00—Program-control systems
- G05B2219/30—Nc systems
- G05B2219/32—Operator till task planning
- G05B2219/32252—Scheduling production, machining, job shop
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P90/00—Enabling technologies with a potential contribution to greenhouse gas [GHG] emissions mitigation
- Y02P90/02—Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]
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- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Automation & Control Theory (AREA)
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Abstract
The invention relates to the technical field of production management, and discloses a method for controlling the process, production and equipment operation linkage of a pharmaceutical production line, wherein an intelligent mass production control system is used for butting all pharmaceutical equipment on the pharmaceutical production line, so that the configuration and the debugging of production process parameters are realized on line and are issued to related pharmaceutical equipment; the batch production intelligent control system can issue batch production instructions on line, and select corresponding production process parameters for production activities according to the production process requirements of the batch standard medicines; the batch production intelligent control system sequentially starts production equipment related to different production procedures according to the sequence of production process flows, the whole production process can be operated by staff on a service terminal by one key, and the equipment is automatically and continuously produced, so that the whole production process activities of traditional Chinese medicines are monitored in the batch production intelligent control system according to the production process flows, the standardization of traditional Chinese medicine production is enhanced, and the stability and uniformity of the quality of traditional Chinese medicine products are improved.
Description
Technical Field
The invention relates to the technical field of production management, in particular to a method for controlling the process, production and equipment operation linkage of a pharmaceutical production line.
Background
In the production of solid preparations, granulation is one of the common procedures, and the method can be divided into dry granulation, wet granulation, one-step granulation and the like. The traditional wet granulation process has the characteristics of high efficiency and high granulation quality, and common equipment comprises a wet granulator, a boiling dryer, a granulator and the like.
Although a plurality of key process control parameters of the granulating process are relatively clear in the actual production process, because of the phenomena of multiple-pot operation and multiple manual intervention in the granulating process, which are caused by multiple equipment and separation operation among the equipment in each process stage, the complex production mode greatly influences the production efficiency and the stability of the product quality, the formula is required to be defined and the batch record is required to be output manually.
Under the background of national promotion of evaluation work of pharmaceutical consistency and strengthening of medicine intelligent supervision policies, the solid preparation industry is urgently required to be provided with a new informatization solution, overcomes the technical difficulty and realizes a new mode of continuous unmanned production.
It is seen that there is a need for a method for controlling the process, production and equipment operation of a pharmaceutical assembly line, so that the whole production process can be operated by staff on a service terminal by one key, and the equipment can be automatically and continuously produced.
Disclosure of Invention
The invention aims to provide a method for controlling the operation linkage of the process, production and equipment of a pharmaceutical production line, so as to solve the problems in the prior art.
In order to solve the technical problems, the invention provides the following technical scheme: a process, production and equipment operation linkage control method of a pharmaceutical production line is characterized in that all pharmaceutical equipment on the pharmaceutical production line is in butt joint through a batch production intelligent control system, the configuration and the debugging of production process parameters are realized on line, and the parameters are issued to related pharmaceutical equipment;
the batch production intelligent control system can issue batch production instructions on line, and select corresponding production process parameters for production activities according to the production process requirements of the batch standard medicines;
the batch production intelligent control system sequentially starts production equipment related to different production procedures according to the sequence of production process flows, and stops the production equipment after the production activities are completed;
the batch production intelligent control system collects equipment running state parameters in real time, analyzes equipment performance parameters and pre-warns possible faults of the equipment;
the batch production intelligent management and control system comprises process parameter management, batch production instruction management, production equipment linkage management and production equipment operation supervision, so that intelligent linkage management of a pharmaceutical equipment production line is realized, and production activities are ensured to meet GMP (good manufacturing practice) regulation and control requirements;
the batch production intelligent management and control system is divided into an equipment layer, a system control layer and a service layer, and the bottom equipment is interconnected to integrate a wet granulator, a fluidized bed and a mixer into a granulation process linkage line;
and uniformly issuing batch production instructions and equipment operation parameters through a system control layer, scheduling the operation of each equipment according to the batch process requirements, monitoring the data such as the equipment operation parameters, state changes, alarm output and the like in real time, and uniformly outputting batch production records after the batch production is finished.
Preferably, the batch production intelligent management and control system comprises equipment management, process recipe management, production line operation monitoring, production operation, alarm management, batch report and audit trail systems.
Preferably, the business process of the batch production intelligent management and control system comprises the following steps: three layers of unpacking and feeding processes, two layers of batching processes, one layer of mixing processes, two layers of material receiving IBC (intermediate bulk container) management and control processes, one layer of material receiving IBC management and control processes and small material feeding station device management and control processes.
Preferably, the three-layer unpacking and feeding process comprises the following steps:
s1, a worker logs in a system to create a production plan and creates an approval production instruction to wait for approval:
s2, issuing an instruction to the PLC of the terminal equipment after approval of the production instruction is completed;
s3, a PLC of the terminal equipment respectively sends instructions to a material claiming process, an unpacking process, a feeding process, a batching process, a small material process and a mixing process;
s4, the material claiming procedure transmits information to a depacketizing room through an NC system to scan codes to confirm the materials, carries out inner package coding on the materials, and enters a temporary warehouse;
the unpacking procedure is prepared before production by logging in a system by a unpacker, and the materials are confirmed by scanning codes;
the pre-production preparation includes room confirmation, equipment confirmation, material retrieval confirmation, and pre-operation inspection item confirmation.
Preferably, the two-layer dosing process comprises the following steps:
s1, a batching operator logs in a system to start entering a batching process;
s2, preparing before production in a system by a batching member;
the preparation before production comprises room confirmation, equipment confirmation, material acquisition confirmation and check item confirmation before operation;
s3, starting batching operation according to the quantity of the instruction list formulas, and scanning codes to confirm IBC barrel information;
s4, logging in a system by a small material preparing person to perform a small material procedure, and preparing before production;
pre-production preparation includes confirming weighing cell cleanliness. Confirming the state of the weighing tool, picking up materials and confirming the preparation of the materials;
s5, material picking is carried out, and picking information is fed back to the NC system;
s6, carrying out online weighing, enabling the weighed small materials to enter a turnover device, and associating the turnover device with a code scanning device;
s7, carrying out small powder throwing by the aid of the related turnover device according to the information of the IBC barrel.
Preferably, the one-layer mixing procedure comprises the steps of:
s1, logging in a system by a mixing staff, preparing before production, and carrying out room confirmation, mixer confirmation, blanking confirmation and pre-operation check item confirmation;
s2, operating a mixer to start mixing, and placing a receiving IBC of a mixing station in place after the mixing is completed;
s3, code scanning confirms IBC information, and simultaneously binds the production formula and batch information of the time, and the IBC barrel information accords with the cleaning state and the requirement of the batch formula information and then is blanked by the mixer;
s4, weighing to obtain the weight of the mixed materials, and transmitting the weight of the materials to an NC system for material balance calculation;
s5, sampling the symmetrically weighted mixture.
Preferably, the two-layer material receiving IBC control flow comprises the following steps:
s1, cleaning an IBC barrel by a cleaning machine;
s2, the cleaning station scans codes to unbind batch information and transfers the unbinding batch information to a two-layer clean charging bucket buffer area;
s3, transferring to a batching station, scanning by the batching station, and binding batch information;
s4, transferring to a small material preparation station, and confirming the small material preparation station by scanning;
s5, transferring to a lifting machine station, and confirming the scanning code of the lifting machine station;
s6, feeding an empty barrel into an empty barrel buffer area, binding batch information, and recycling the same formula when the barrel is a non-clean barrel;
and S7, when the cleaning is needed again, repeating the step S1.
Preferably, the one-layer material receiving IBC control flow comprises the following steps:
s1, cleaning IBC by a cleaning machine, and unbinding batch information;
s2, a station of the cleaning machine scans codes, does not enter a buffer area and is used for distinguishing cleaned and unwashed charging barrels;
s3, the drying station sweeps the code and transfers the code to a layer of clean charging basket buffer area;
s4, transferring to a mixed material receiving station, and binding batch information;
s5, scanning the code in the mixed material receiving station, and transferring to a finished product caching station;
s6, leaving the warehouse or leaving the factory, and returning the IBC barrel to the cleaning machine.
Preferably, the control flow of the small-size feeding station device comprises the following steps:
s1, manually cleaning the appliance, scanning codes of the cleaned appliance, and unbinding batch information;
s2, transferring to a two-layer clean charging bucket buffer area, and binding batch information to a turnover device buffer area;
s3, the batching station scans the codes, transfers the samples to a batching station, and scans the codes through the batching station to confirm;
s4, transferring to a lifting machine station, and confirming the scanning code of the lifting machine station;
s5, the empty barrel enters an empty barrel buffer area, and when the barrel is an unclean barrel, the same formula can be recycled and circulated to a turnover device temporary storage area;
s6, when the empty barrel needs to be cleaned, cleaning by a layer of cleaning machine.
Compared with the prior art, the invention has the following beneficial effects:
the system control layer uniformly issues batch production instructions and equipment operation parameters (batch process formula), equipment operation is scheduled according to batch process requirements, data such as equipment operation parameters, state changes, alarm output and the like are monitored in real time, batch production records are uniformly output after batch production is finished, the whole production process can be operated by staff on a service terminal in one key, equipment is automatically and continuously produced, and therefore the whole production process activities of traditional Chinese medicines are monitored according to the production process flow in the batch production intelligent control system, standardization of traditional Chinese medicine production is enhanced, and stability and uniformity of traditional Chinese medicine product quality are improved.
Drawings
FIG. 1 is a schematic diagram of a control system according to the present invention;
FIG. 2 is a schematic diagram of a system architecture according to the present invention;
FIG. 3 is a schematic diagram of a three-layer unpacking and feeding process according to the present invention;
FIG. 4 is a schematic diagram of a two-layer compounding process according to the present invention;
FIG. 5 is a schematic diagram of a layer of a mixing process according to the present invention;
FIG. 6 is a flow chart of a two-layer material receiving IBC control according to the present invention;
FIG. 7 is a flow chart of one layer of material receiving IBC control according to the present invention;
FIG. 8 is a flow chart of the control of the small-sized material feeding station apparatus of the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Referring to fig. 1-2, a method for controlling the operation of a process, production and equipment of a pharmaceutical production line is disclosed, wherein all pharmaceutical equipment on the pharmaceutical production line is docked by a batch production intelligent control system, the configuration and the debugging of production process parameters are realized on line, and the configuration and the debugging are issued to related pharmaceutical equipment;
the batch production intelligent control system can issue batch production instructions on line, and select corresponding production process parameters for production activities according to the production process requirements of the batch standard medicines;
the batch production intelligent control system sequentially starts production equipment related to different production procedures according to the sequence of production process flows, and stops the production equipment after the production activities are completed;
the batch production intelligent control system collects equipment running state parameters in real time, analyzes equipment performance parameters and pre-warns possible faults of the equipment;
the batch production intelligent management and control system comprises process parameter management, batch production instruction management, production equipment linkage management and production equipment operation supervision, so that intelligent linkage management of a pharmaceutical equipment production line is realized, and production activities are ensured to meet GMP (good manufacturing practice) regulation and control requirements;
the batch production intelligent management and control system is divided into an equipment layer, a system control layer and a service layer, and the bottom equipment is interconnected to integrate a wet granulator, a fluidized bed and a mixer into a granulation process linkage line;
and uniformly issuing batch production instructions and equipment operation parameters through a system control layer, scheduling the operation of each equipment according to the batch process requirements, monitoring the data such as the equipment operation parameters, state changes, alarm output and the like in real time, and uniformly outputting batch production records after the batch production is finished.
The batch production intelligent management and control system comprises equipment management, process recipe management, production line operation monitoring, production operation, alarm management, batch report and audit trail systems;
the equipment management, which integrates all the equipment into a linkage production line through equipment interconnection, configures equipment information including equipment name, model, communication protocol, IP address and other information, knows the equipment state in real time, evaluates the equipment performance, discovers potential faults, forms fault early warning and other schemes, and achieves fine management;
the process recipe management, according to different batch process requirements, the system sets recipe parameters and process flows, generates batch production instructions and sends the batch production instructions to equipment for execution of each process, so that manual intervention is reduced;
monitoring the operation of the production line, acquiring and monitoring the data of the operation state and parameters of the wet granulation line through the system, and realizing the control of the operation states such as start-stop and process circulation of the wet granulation line through the system, so as to timely and accurately know the production state;
the production operation, which is to start and stop the equipment on the production line and issue the process formula, adopts a one-key production function to operate and schedule the work order, so as to realize continuous production;
alarm management, namely setting an alarm threshold and a grade of abnormal equipment operation, dynamically searching generated alarms according to configuration information and process operation conditions by a system, displaying alarm information meeting the conditions, processing the alarm information, and reducing hidden danger in the production process;
batch report forms batch production records of production process data acquired by each process in batch production process, and batch production reports are automatically issued and archived through an approval process, so that the batch report does not depend on manual records any more;
and the audit trail is carried out on parameter modification and system operation during operation, a trail audit log is automatically created, user operation events are recorded, electronic record data cannot be modified once generated, data tampering is prevented, and information safety, compliance and traceability are ensured.
Mass production procedures are defined in ISA-S88: a process of processing a limited amount of material in one or more apparatuses in a prescribed processing sequence to obtain a limited amount of product, simply a process of mass production in sequential operating steps. The multi-variety collineation is the biggest difficulty of mass production, and the flexibility is the biggest advantage of a mass production method, and the adoption of the wet granulation line BATCH intelligent management and control system can obviously enhance the operation flexibility of the mass production process, and is free from the dependence on programming control personnel of a production line.
The system can realize the automatic, continuous and standardized operation of the wet granulation linkage line, greatly improve the production efficiency and promote the quality uniformity of medicines; the running condition of the equipment is monitored on line in real time, abnormal events are managed in advance, the risk of medicine quality accidents is reduced, and the production cost of enterprises is saved.
On the basis, the system further provides the functions of equipment fault pre-diagnosis and equipment OEE statistical analysis, and a unified daily management platform is provided for production equipment; the method provides real-time data of process parameters for batch production, promotes batch record electronic management, and lays a solid foundation for digital pharmacy.
Referring to fig. 3-8, the implementation method of dynamic scheduling of Chinese medicine extraction production provided by the application adopts the following technical scheme;
the business process of the batch production intelligent management and control system comprises the following steps: three layers of unpacking and feeding processes, two layers of batching processes, a first layer of mixing processes, two layers of material receiving IBC (intermediate bulk carrier) control processes, a first layer of material receiving IBC control processes and a small material feeding station device control process;
the three-layer unpacking and feeding process comprises the following steps:
s1, a worker logs in a system to create a production plan and creates an approval production instruction to wait for approval:
s2, issuing an instruction to the PLC of the terminal equipment after approval of the production instruction is completed;
s3, a PLC of the terminal equipment respectively sends instructions to a material claiming process, an unpacking process, a feeding process, a batching process, a small material process and a mixing process;
s4, the material claiming procedure transmits information to a depacketizing room through an NC system to scan codes to confirm the materials, carries out inner package coding on the materials, and enters a temporary warehouse;
the unpacking procedure is prepared before production by logging in a system by a unpacker, and the materials are confirmed by scanning codes;
the pre-production preparation includes room confirmation, equipment confirmation, material retrieval confirmation, and pre-operation inspection item confirmation.
The two-layer batching flow comprises the following steps:
s1, a batching operator logs in a system to start entering a batching process;
s2, preparing before production in a system by a batching member;
the preparation before production comprises room confirmation, equipment confirmation, material acquisition confirmation and check item confirmation before operation;
s3, starting batching operation according to the quantity of the instruction list formulas, and scanning codes to confirm IBC barrel information;
s4, logging in a system by a small material preparing person to perform a small material procedure, and preparing before production;
pre-production preparation includes confirming weighing cell cleanliness. Confirming the state of the weighing tool, picking up materials and confirming the preparation of the materials;
s5, material picking is carried out, and picking information is fed back to the NC system;
s6, carrying out online weighing, enabling the weighed small materials to enter a turnover device, and associating the turnover device with a code scanning device;
s7, carrying out small powder throwing by the aid of the related turnover device according to the information of the IBC barrel.
The one-layer mixing process comprises the following steps:
s1, logging in a system by a mixing staff, preparing before production, and carrying out room confirmation, mixer confirmation, blanking confirmation and pre-operation check item confirmation;
s2, operating a mixer to start mixing, and placing a receiving IBC of a mixing station in place after the mixing is completed;
s3, code scanning confirms IBC information, and simultaneously binds the production formula and batch information of the time, and the IBC barrel information accords with the cleaning state and the requirement of the batch formula information and then is blanked by the mixer;
s4, weighing to obtain the weight of the mixed materials, and transmitting the weight of the materials to an NC system for material balance calculation;
s5, sampling the symmetrically weighted mixture.
The two-layer material receiving IBC control flow comprises the following steps:
s1, cleaning an IBC barrel by a cleaning machine;
s2, the cleaning station scans codes to unbind batch information and transfers the unbinding batch information to a two-layer clean charging bucket buffer area;
s3, transferring to a batching station, scanning by the batching station, and binding batch information;
s4, transferring to a small material preparation station, and confirming the small material preparation station by scanning;
s5, transferring to a lifting machine station, and confirming the scanning code of the lifting machine station;
s6, feeding an empty barrel into an empty barrel buffer area, binding batch information, and recycling the same formula when the barrel is a non-clean barrel;
and S7, when the cleaning is needed again, repeating the step S1.
The one-layer material receiving IBC control flow comprises the following steps:
s1, cleaning IBC by a cleaning machine, and unbinding batch information;
s2, a station of the cleaning machine scans codes, does not enter a buffer area and is used for distinguishing cleaned and unwashed charging barrels;
s3, the drying station sweeps the code and transfers the code to a layer of clean charging basket buffer area;
s4, transferring to a mixed material receiving station, and binding batch information;
s5, scanning the code in the mixed material receiving station, and transferring to a finished product caching station;
s6, leaving the warehouse or leaving the factory, and returning the IBC barrel to the cleaning machine.
The control flow of the small-size feeding station device comprises the following steps:
s1, manually cleaning the appliance, scanning codes of the cleaned appliance, and unbinding batch information;
s2, transferring to a two-layer clean charging bucket buffer area, and binding batch information to a turnover device buffer area;
s3, the batching station scans the codes, transfers the samples to a batching station, and scans the codes through the batching station to confirm;
s4, transferring to a lifting machine station, and confirming the scanning code of the lifting machine station;
s5, the empty barrel enters an empty barrel buffer area, and when the barrel is an unclean barrel, the same formula can be recycled and circulated to a turnover device temporary storage area;
s6, when the empty barrel needs to be cleaned, cleaning by a layer of cleaning machine.
The application of the Batch intelligent control system is promoted, an effective linkage management means of a pharmaceutical equipment production line is provided for a medicine production enterprise, customers are helped to improve the production management level and the production efficiency, and greater benefits are obtained for the customers.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (9)
1. A process, production and equipment operation linkage control method of a pharmaceutical production line is characterized in that: the intelligent control system for batch production is used for butt joint of all pharmaceutical equipment on a pharmaceutical production line, so that the configuration and the debugging of production process parameters are realized on line and are issued to related pharmaceutical equipment;
the batch production intelligent control system can issue batch production instructions on line, and select corresponding production process parameters for production activities according to the production process requirements of the batch standard medicines;
the batch production intelligent control system sequentially starts production equipment related to different production procedures according to the sequence of production process flows, and stops the production equipment after the production activities are completed;
the batch production intelligent control system collects equipment running state parameters in real time, analyzes equipment performance parameters and pre-warns possible faults of the equipment;
the batch production intelligent management and control system comprises process parameter management, batch production instruction management, production equipment linkage management and production equipment operation supervision, so that intelligent linkage management of a pharmaceutical equipment production line is realized, and production activities are ensured to meet GMP (good manufacturing practice) regulation and control requirements;
the batch production intelligent management and control system is divided into an equipment layer, a system control layer and a service layer, and the bottom equipment is interconnected to integrate a wet granulator, a fluidized bed and a mixer into a granulation process linkage line;
and uniformly issuing batch production instructions and equipment operation parameters through a system control layer, scheduling the operation of each equipment according to the batch process requirements, monitoring the data such as the equipment operation parameters, state changes, alarm output and the like in real time, and uniformly outputting batch production records after the batch production is finished.
2. The method for controlling the operation linkage of the process, the production and the equipment of the pharmaceutical production line according to claim 1, wherein the method comprises the following steps of: the batch production intelligent management and control system comprises equipment management, process recipe management, production line operation monitoring, production operation, alarm management, batch report and audit trail systems.
3. The method for controlling the operation linkage of the process, the production and the equipment of the pharmaceutical production line according to claim 1, wherein the method comprises the following steps of: the business process of the batch production intelligent management and control system comprises the following steps: three layers of unpacking and feeding processes, two layers of batching processes, one layer of mixing processes, two layers of material receiving IBC (intermediate bulk container) management and control processes, one layer of material receiving IBC management and control processes and small material feeding station device management and control processes.
4. A method of process, production and equipment operation linkage control for a pharmaceutical manufacturing line according to claim 3, wherein: the three-layer unpacking and feeding process comprises the following steps:
s1, a worker logs in a system to create a production plan and creates an approval production instruction to wait for approval:
s2, issuing an instruction to the PLC of the terminal equipment after approval of the production instruction is completed;
s3, a PLC of the terminal equipment respectively sends instructions to a material claiming process, an unpacking process, a feeding process, a batching process, a small material process and a mixing process;
s4, the material claiming procedure transmits information to a depacketizing room through an NC system to scan codes to confirm the materials, carries out inner package coding on the materials, and enters a temporary warehouse;
the unpacking procedure is prepared before production by logging in a system by a unpacker, and the materials are confirmed by scanning codes;
the pre-production preparation includes room confirmation, equipment confirmation, material retrieval confirmation, and pre-operation inspection item confirmation.
5. A method of process, production and equipment operation linkage control for a pharmaceutical manufacturing line according to claim 3, wherein: the two-layer batching flow comprises the following steps:
s1, a batching operator logs in a system to start entering a batching process;
s2, preparing before production in a system by a batching member;
the preparation before production comprises room confirmation, equipment confirmation, material acquisition confirmation and check item confirmation before operation;
s3, starting batching operation according to the quantity of the instruction list formulas, and scanning codes to confirm IBC barrel information;
s4, logging in a system by a small material preparing person to perform a small material procedure, and preparing before production;
pre-production preparation includes confirming weighing cell cleanliness; confirming the state of the weighing tool, picking up materials and confirming the preparation of the materials;
s5, material picking is carried out, and picking information is fed back to the NC system;
s6, carrying out online weighing, enabling the weighed small materials to enter a turnover device, and associating the turnover device with a code scanning device;
s7, carrying out small powder throwing by the aid of the related turnover device according to the information of the IBC barrel.
6. A method of process, production and equipment operation linkage control for a pharmaceutical manufacturing line according to claim 3, wherein: the one-layer mixing process comprises the following steps:
s1, logging in a system by a mixing staff, preparing before production, and carrying out room confirmation, mixer confirmation, blanking confirmation and pre-operation check item confirmation;
s2, operating a mixer to start mixing, and placing a receiving IBC of a mixing station in place after the mixing is completed;
s3, code scanning confirms IBC information, and simultaneously binds the production formula and batch information of the time, and the IBC barrel information accords with the cleaning state and the requirement of the batch formula information and then is blanked by the mixer;
s4, weighing to obtain the weight of the mixed materials, and transmitting the weight of the materials to an NC system for material balance calculation;
s5, sampling the symmetrically weighted mixture.
7. A method of process, production and equipment operation linkage control for a pharmaceutical manufacturing line according to claim 3, wherein: the two-layer material receiving IBC control flow comprises the following steps:
s1, cleaning an IBC barrel by a cleaning machine;
s2, the cleaning station scans codes to unbind batch information and transfers the unbinding batch information to a two-layer clean charging bucket buffer area;
s3, transferring to a batching station, scanning by the batching station, and binding batch information;
s4, transferring to a small material preparation station, and confirming the small material preparation station by scanning;
s5, transferring to a lifting machine station, and confirming the scanning code of the lifting machine station;
s6, feeding an empty barrel into an empty barrel buffer area, binding batch information, and recycling the same formula when the barrel is a non-clean barrel;
and S7, when the cleaning is needed again, repeating the step S1.
8. A method of process, production and equipment operation linkage control for a pharmaceutical manufacturing line according to claim 3, wherein: the one-layer material receiving IBC control flow comprises the following steps:
s1, cleaning IBC by a cleaning machine, and unbinding batch information;
s2, a station of the cleaning machine scans codes, does not enter a buffer area and is used for distinguishing cleaned and unwashed charging barrels;
s3, the drying station sweeps the code and transfers the code to a layer of clean charging basket buffer area;
s4, transferring to a mixed material receiving station, and binding batch information;
s5, scanning the code in the mixed material receiving station, and transferring to a finished product caching station;
s6, leaving the warehouse or leaving the factory, and returning the IBC barrel to the cleaning machine.
9. A method of process, production and equipment operation linkage control for a pharmaceutical manufacturing line according to claim 3, wherein: the control flow of the small-size feeding station device comprises the following steps:
s1, manually cleaning the appliance, scanning codes of the cleaned appliance, and unbinding batch information;
s2, transferring to a two-layer clean charging bucket buffer area, and binding batch information to a turnover device buffer area;
s3, the batching station scans the codes, transfers the samples to a batching station, and scans the codes through the batching station to confirm;
s4, transferring to a lifting machine station, and confirming the scanning code of the lifting machine station;
s5, the empty barrel enters an empty barrel buffer area, and when the barrel is an unclean barrel, the same formula can be recycled and circulated to a turnover device temporary storage area;
s6, when the empty barrel needs to be cleaned, cleaning by a layer of cleaning machine.
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