CN112101771A - Automatic production control system and production method for Danshu soft capsules - Google Patents
Automatic production control system and production method for Danshu soft capsules Download PDFInfo
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Abstract
The invention belongs to the field of medicine preparation, and particularly relates to an automatic production control system and a production method of Danshu soft capsules, wherein the automatic production control system comprises an electronic batch recording system, an MES system and an automatic equipment system; the MES system receives the production task, processes the production task to obtain production information and transmits the production information to the electronic batch recording system and the automatic equipment system; the automatic equipment system transmits actual production data acquired in production to the MES system and the electronic batch recording system; and the MES system processes the actual production data and transmits the actual production data to the electronic batch recording system for a decision maker to check and process. The production system and the corresponding production method from the storage of the raw materials of the Danshu soft capsules to the delivery of finished products of the Danshu soft capsules are established, production data monitoring is implemented, production quality is controlled, quality control is facilitated, and generation efficiency and medicine quality are improved under the condition of saving labor.
Description
Technical Field
The invention belongs to the field of intelligent medicine manufacturing, and particularly relates to an automatic production control system and a production method of Danshu soft capsules.
Background
The MES system is a production informatization management system facing to a workshop execution layer of a manufacturing enterprise. The MES can provide management modules for enterprises, such as manufacturing data management, planning scheduling management, production scheduling management, inventory management, quality management, human resource management, work center/equipment management, tool and tool management, purchasing management, cost management, project bulletin board management, production process control, bottom layer data integration analysis, upper layer data integration decomposition and the like, and create a solid, reliable, comprehensive and feasible manufacturing cooperative management platform for the enterprises.
In recent years, with the introduction of new production models such as JIT and BTO and the demand of customers and markets for higher product quality, MES has been newly discovered and valued. Meanwhile, after the network economic foam is broken, enterprises begin to realize that the competitiveness needs to be improved from the most basic production management, namely, only data information is taken out from a product level, passes through an operation control level and reaches a management level, and enterprise information integration is realized through continuous information flow, so that the enterprises can stand in increasingly intense competition. MES is rapidly and widely used abroad. The manufacturing execution system aims at improving the execution capacity of enterprises and has irreplaceable functions, process enterprises in a competitive environment need to distinguish the targets and the functions of different manufacturing management systems, the positioning of the MES in the integrated system is determined, the accuracy, timeliness, standard flow, tools utilization and management innovation of information are emphasized, the execution capacity of the MES is analyzed according to an MES maturity model, the MES is implemented step by step according to three stages of information integration, transaction processing and manufacturing intelligence, the informatization function of the enterprises can be fully exerted, the competitiveness of the enterprises is improved, and expected benefits are brought to the enterprises.
The intelligent manufacturing is revolutionary integration, remodeling and innovation of enterprises and value chains in multiple dimensions by means of a new technology, so that participants of the whole industry chain participate in completing development, sale and even ending of product life of products in a flexible, autonomous and open cooperative system.
With the maturity of the technology and the reduction of the manufacturing cost, the wide application of intelligent equipment such as industrial robots and mechanical arms is promoted, and starting from the automation of single equipment and the intelligence of products, the key process intelligence and the substitution of key post robots are fastened, and the improvement of the production efficiency and the efficiency of products is realized.
The way of intelligent manufacturing in the pharmaceutical industry of China is just beginning, so-called intelligent manufacturing and intelligent factories do not form true reasonable and complete forms and modes, a plurality of special problems in the pharmaceutical industry need to be seriously considered and explored, and some partial or local automatic, informatization or intelligent contents are not taken as the integral mode of the pharmaceutical industry, and some modes of other industries are not simply taken to the pharmaceutical industry.
Innovative technologies and equipment are the core for promoting the revolution of the pharmaceutical industry. The intelligent manufacturing of the pharmaceutical industry is realized, and the key tasks are 'pharmaceutical equipment intellectualization' and 'drug production process intellectualization'. The production efficiency is improved, the resource and energy consumption is reduced, and the method has important significance for promoting transformation and upgrading of the pharmaceutical industry. The pharmaceutical industry self characteristics and demand are combined, the automation and informatization idea and level of the pharmaceutical industry are improved, the integral solution of intelligent pharmaceutical engineering which highly accords with the drug production and GMP compliance is ensured, and the problem to be solved urgently in the pharmaceutical industry is solved.
Disclosure of Invention
One of the purposes of the invention is to provide an automatic production method of the Danshu soft capsule, which can realize the quality control problem of the Danshu soft capsule melting, pressing and pill selecting process in intelligent manufacturing, and monitor various data in the generation link, thereby being beneficial to the quality control of the Danshu soft capsule.
In order to achieve the purpose, the technical scheme of the invention is as follows:
an automatic production method of Danshu soft capsules comprises a capsule melting process, and specifically comprises the following steps:
s1: mixing ethyl p-hydroxybenzoate, 95% alcohol, water, glycerol, gelatin, sorbitol and polysorbate 80 as raw materials of the Danshu soft capsule to obtain a premixed material I;
s2: adding the raw materials of the Danshu soft capsule into a gelatin melting tank for gelatin melting to obtain a mixed gelatin solution II;
s3: recording the waste material III in the step;
the weighing module acquires the mass of the premixed material I, the mass of the mixed glue solution II and the mass of the waste material III, and transmits mass data to the mass management module to calculate the material yield and the material balance rate; the material yield is performed downwards when the yield is between 90.0 and 100.0 percent, and deviation is not generated when the yield is between 90.0 and 100.0 percent; the material balance rate is carried out downwards when being 92.0-100.0%, and deviation is not generated when being 92.0-100.0%; the quality management module transmits the deviation to a deviation management module; the deviation management module stores and displays the deviation, receives a command for processing the deviation and transmits the command to an automatic equipment system;
the calculation formula of the material yield is as follows:
the formula for calculating the material balance rate is as follows:
further, the automation equipment system comprises an information receiving and processing module and automation equipment; the information receiving and processing module is used for receiving and processing production instruction information, transmitting the production instruction information to the automation equipment, and collecting and storing actual production information acquired by the automation equipment;
further, the method also comprises a pill pressing and selecting process, and specifically comprises the following steps:
1) putting the mixed glue solution II and the mixed liquid medicine of the corn oil and the peppermint oil into a soft capsule pelleting press for pelleting;
2) selecting the soft capsule pills produced in the step 1),
and the quality management module acquires the process parameters and the loading condition in production every half hour, compares the process parameters and the loading condition with a standard data range, generates deviation if the process parameters and the loading condition are not in the standard range, and reports the deviation to the deviation management module for processing.
The second purpose of the invention is to provide an automatic Danshu soft capsule production control system, which can realize automatic production, monitor production data in real time and know production conditions.
In order to achieve the purpose, the technical scheme provided by the invention is as follows:
an automatic production control system for Danshu soft capsules comprises an electronic batch recording system, an MES system and an automatic equipment system; the MES system receives the production task, processes the production task to obtain production information and transmits the production information to the electronic batch recording system and the automatic equipment system; the automatic equipment system transmits actual production data acquired in production to the MES system and the electronic batch recording system; the MES system processes the actual production data and then transmits the actual production data to the electronic batch recording system for a decision maker to check and process;
the electronic batch recording system complies with FDA and GMP specifications, designs the whole process rules and SOPs into the system in an electronic mode, guides and controls operators or PLC (programmable logic controllers) to control operation to execute production tasks strictly according to the process rules, and specifically comprises the following modules:
designing a module: for designing electronic master batch records and complying with FDA-GMP manufacturing standards and ISA 88 standards;
an execution module: managing a human-machine interface of the whole execution process of the production instruction according to the dynamic processing tree;
a review module: providing a checking function for the electronic batch records, providing an electronic signature and accelerating the release of the batch, and using the electronic signature and the batch as a whole execution system for checking;
the automatic equipment system comprises an information receiving and processing module and automatic equipment; the information receiving and processing module is used for receiving and processing the production information, converting the production information into a production instruction, transmitting the production instruction to the automation equipment for producing the Danshu soft capsules, and collecting and storing actual production data acquired by the automation equipment;
further, the electronic batch record design, the electronic batch record execution and the electronic batch record audit in the electronic batch record system are as follows:
electronic batch record design: designing a main batch record, and designing the whole process procedure and SOPs;
electronic batch record execution: supporting an operator in a production work order by displaying a manufacturing guide; ensure data collection and associated production labeling; control the execution of various manufacturing tasks; managing deviation in real time; automatically generating batch records;
and (4) electronic batch record auditing: the method mainly comprises the following steps: deviation processing, family tree checking, audit tracking, weighing report and electronic batch record approval and release;
the electronic batch recording system lists all deviations in batch production, and requires quality personnel to process and electronically sign one by one.
Further, the automatic equipment comprises a soft capsule pill pressing machine, a batching tank, a gelatin melting tank, a combined double-layer drying rotating cage, a heat-preservation gelatin storage barrel, an automatic box packing machine, an aluminum-plastic packaging machine, a pill selecting machine and a pillow packing machine;
further, the electronic batch recording system also comprises an account management module, an electronic signature module and a material flow module;
the account management module provides role-based access control; the authority is given to the role, and different roles can have partially same authority; and providing an electronic signature in compliance with the requirements; and providing access control audit trails;
the electronic signature of the activity or operation of the electronic signature module is bound with the authority, and whether a signer is authorized to confirm the related activity or operation is identified; the electronic signature module comprises the following signature types:
single label: if the user role of the signer can not meet the preset authority requirement of the signature, the signature fails;
double sticks: if the user role of the signer can not completely meet the preset authority requirement of the signature, the system pops up a second signature box for the second signer to sign so as to meet the authority requirement;
and (4) single-label checking: the signer must be inconsistent with the user logging into the system;
double-label checking: the signature must be done by both signers together;
the preset authority of the single-signature and double-signature electronic signature types can set different signature failure alarm levels; the alarm level is divided into: if the preset authority of the signature is not satisfied, the system automatically generates and records an alarm according to the set alarm level;
the material flow module comprises a material definition unit, a warehouse management unit, a weighing and batching unit, a material centralizing unit, a feeding operation unit and an output statement unit;
further, the material definition unit includes:
defining basic attributes: material codes, names, specifications, material types, stock units and packaging units, standard titer, standard density and ingredient loss rate;
weighing attribute definition: whether distribution weighing is allowed or not, whether manufacturing weighing is allowed or not, whether packaging weighing is allowed or not, distribution weighing precision, manufacturing weighing precision, a standard weighing work center, weighing batch management, weighing mixed batch control, weighing supplier batch mixed batch control and weighing mode selection;
batch/warehouse attribute definition: the method comprises the following steps of (1) receiving a default state of a material batch, whether the batch allows automatic materials or not, the validity period of the batch, the re-inspection period of the batch, reminding of the allowance of the finished batch, the minimum inventory, ABC codes of inventory, the storage attribute of the materials, a priority storage area for batch receiving, an overflow bulk storage area, a material receiving position, a sampling area, the expiration period of bottle opening and material labeling rules;
the hazard/prevention attribute defines: danger warning and precautionary measure prompt of materials, dangerous goods GHS icon and material processing prompt information;
extended annotation attribute definition: defining the expansion aiming at the material attribute in the project engineering;
the electronic batch recording system realizes the synchronization of system material definition and ERP material definition through a standard enterprise integration interface;
the warehouse management unit includes:
preparing a warehouse: storage medium definition for supporting materials in warehouse preparation, warehouse location, warehouse area and section definition, work center definition and delivery path definition;
batch receiving: the batch receipt is created through an enterprise integration interface or manually. The warehouse operator performs sub-packaging of the materials according to the actual material batch-to-cargo packaging mode, and the system automatically prints material packaging bar code labels;
sampling: after receiving the material batch, the system automatically generates a minimum package sampling list according to a material sampling rule;
and (3) batch release: after the batch inspection result is obtained, batch release work is executed, and batch release information is synchronized to the ERP system through the enterprise integration interface;
warehouse operation: supporting daily operations of the warehouse through a mobile client, wherein the daily operations comprise material group support, pallet merging/splitting, inventory movement and inventory information query;
inventory checking: support periodic inventory;
automatically picking materials according to batches: after the production work order is created, automatically generating a warehouse material receiving request according to a bill of materials;
material taking and ex-warehouse: creating a material receiving list, scanning a material bar code according to the material receiving list by a warehouse manager, and printing the material receiving list;
warehouse management audit trail;
the electronic batch recording system synchronizes information with an ERP or an external warehouse management system through an enterprise integration interface;
the weighing and batching unit is internally provided with a plurality of communication protocol drivers of common electronic scale brands and can be directly connected with an electronic scale for use;
the material centralizing unit performs centralized operation on the weighed materials and the materials before feeding;
the feeding operation unit prepares feeding according to the stage/sequence/dosage range of the work order.
The output statement unit uses the master batch record modeling label to prepare an output statement, and the output statement comprises a product code, a product batch state, whether a bar code label is printed or not, a batch production date, an output quantity, a production unit, whether ERP uploads output or not, whether output is in equipment or not, the quantity of output packages, the types of packages and the output positions.
Furthermore, the MES system comprises a bill of material module, a formula management module, a scheduling management module, a work order management module, a quality management module, a deviation processing module, a weighing module and an equipment management module;
the bill of material module comprises effective time, state, auditors and the number of formula units; the materials in the BOM comprise information such as the input sequence, whether weighing is needed, the input stage, the unit quantity and the like;
the formula management module is used for creating, viewing and modifying a formula;
the scheduling management module is used for reading the production data from the ERP enterprise management system and automatically decomposing the production data into daily batch work orders according to the ERP enterprise management system; automatically generating work orders in batches according to a predefined product production period template;
the work order management module is used for tracking the production process, and managing a system and requiring an operator to process a corresponding work flow in each production stage;
the quality management module is used for creating an inspection document for the to-be-inspected material in the raw and auxiliary material warehouse according to a sampling rule, making batch quality judgment according to an inspection result and communicating the judgment result to the WMS system; reading process and environment quality data, and giving batch quality results according to a judgment standard; creating an inspection bill for the semi-finished product and the finished product, and judging the quality according to an inspection structure;
the deviation processing module is used for automatically generating deviation under the condition that the expected design of the production information is not accordant, and the deviation is processed by predefined related personnel and finally audited by QA; the deviation processing module comprises the following three processing modes:
circulation mode: after the deviation appears, circularly executing the step of generating the deviation again;
a stop mode: after the deviation appears, prohibiting any production operation until QA finishes the deviation processing;
yielding execution mode: after the deviation appears, the production is continuously executed, and QA synchronously processes the deviation;
the weighing module is characterized in that: acquiring relevant weight data of raw materials, materials and intermediate materials in the production of the Danshu soft capsule, and transmitting the relevant weight data to the quality management module, the electronic batch recording system and the ERP system;
the device management module specifically comprises:
equipment account/card management;
equipment maintenance cycle management;
creating a maintenance plan, reminding due, and inputting a maintenance result;
managing equipment faults;
sudden fault maintenance, reason analysis, maintenance result input and spare part replacement;
device movement and location management;
CIP/SIP state change control management of the equipment;
managing the calibration state and the expiration date of the weighing instrument;
management of accessory devices of the device;
managing the occupied state of the materials and the types and the quantity of the materials in the equipment;
management of device capacity and related attributes;
managing the circulation times of the finite state;
performing material transfer premise management between devices;
the MBR module systematically manages key parameters of the production process, the process instruction flow is kept unchanged, and the process parameters can be adjusted according to an actual production plan.
The invention also aims to provide a method for producing the Danshu soft capsules by using the second-purpose automatic production control system for the Danshu soft capsules.
In order to achieve the purpose, the technical scheme provided by the invention is as follows:
an automatic production method of Danshu soft capsules, which applies a Danshu soft capsule automatic production control system of the second purpose, the method comprises the following steps: the automatic production control system comprises an electronic batch recording system, an MES system and an automatic equipment system; the MES system receives the production task, processes the production task to obtain production information and transmits the production information to the electronic batch recording system and the automatic equipment system; the automatic equipment system transmits actual production data acquired in production to the MES system and the electronic batch recording system; the MES system processes the actual production data and then transmits the actual production data to the electronic batch recording system for a decision maker to check and process;
the electronic batch recording system complies with FDA and GMP specifications, designs the whole process rules and SOPs into the system in an electronic mode, guides and controls operators or PLC (programmable logic controllers) to control operation to execute production tasks strictly according to the process rules, and specifically comprises the following modules:
designing a module: for designing electronic master batch records and complying with FDA-GMP manufacturing standards and ISA 88 standards;
an execution module: managing a human-machine interface of the whole execution process of the production instruction according to the dynamic processing tree;
a review module: providing a checking function for the electronic batch records, providing an electronic signature and accelerating the release of the batch, and using the electronic signature and the batch as a whole execution system for checking;
the automatic equipment system comprises an information receiving and processing module and automatic equipment; the information receiving and processing module is used for receiving and processing the production information, converting the production information into a production instruction, transmitting the production instruction to the automation equipment for producing the Danshu soft capsules, and collecting and storing actual production data acquired by the automation equipment.
The invention has the beneficial effects that:
1. a set of production system from storage of raw materials of the Danshu soft capsules to delivery of finished products of the Danshu soft capsules and a corresponding production method are established, production data monitoring is implemented, production quality is controlled, quality control is facilitated, and generation efficiency and medicine quality are improved under the condition of saving labor;
2. provides a method for a capsule selection process of capsule pressing in the production of Danshu soft capsules, which controls the production quality problem in the process;
3. in the whole production control system, the whole process is paperless, the production procedure is simplified, and convenience is provided for production.
Drawings
FIG. 1: the flow schematic diagram of the automatic production method of the Danshu soft capsule;
FIG. 2: an automatic production control system diagram of DANSHU Soft Capsule.
Detailed Description
The examples are given for the purpose of better illustration of the invention, but the invention is not limited to the examples. Therefore, those skilled in the art should make insubstantial modifications and adaptations to the embodiments of the present invention in light of the above teachings and remain within the scope of the invention.
Example 1
According to the attached figure 1, the flow chart of the automatic production method of the Danshu soft capsule is shown, the method comprises a glue dissolving process, and specifically comprises the following steps:
s1: mixing ethyl p-hydroxybenzoate, 95% alcohol, water, glycerol, gelatin, sorbitol and polysorbate 80 as raw materials of the Danshu soft capsule to obtain a premixed material I;
s2: adding the raw materials of the Danshu soft capsule into a gelatin melting tank for gelatin melting to obtain a mixed gelatin solution II;
s3: recording the waste material III in the step;
the weighing module acquires the mass of the premixed material I, the mass of the mixed glue solution II and the mass of the waste material III, and transmits mass data to the mass management module to calculate the material yield and the material balance rate; the material yield is performed downwards when the yield is between 90.0 and 100.0 percent, and deviation is not generated when the yield is between 90.0 and 100.0 percent; the material balance rate is carried out downwards when being 92.0-100.0%, and deviation is not generated when being 92.0-100.0%; the quality management module transmits the deviation to a deviation management module; the deviation management module stores and displays the deviation, receives a command for processing the deviation and transmits the command to an automatic equipment system;
the calculation formula of the material yield is as follows:
the formula for calculating the material balance rate is as follows:
the automatic equipment system comprises an information receiving and processing module and automatic equipment; the information receiving and processing module is used for receiving and processing production instruction information, transmitting the production instruction information to the automation equipment, and collecting and storing actual production information acquired by the automation equipment;
the method also comprises a pill pressing and selecting process, and specifically comprises the following steps:
1) putting the mixed glue solution II and the mixed liquid medicine of the corn oil and the peppermint oil into a soft capsule pelleting press for pelleting;
2) selecting the soft capsule pills produced in the step 1),
and the quality management module acquires the process parameters and the loading condition in production every half hour, compares the process parameters and the loading condition with a standard data range, generates deviation if the process parameters and the loading condition are not in the standard range, and reports the deviation to the deviation management module for processing.
According to the method, the product quality problem in the gelatin dissolving process in the automatic production of the Danshu soft capsules can be effectively controlled, different allowable range values can be set according to the actual production condition to produce the controlled medicine quality, and the production method can be also suitable for other production process flows.
According to the figure 2, the automatic production control system of the Danshu soft capsules comprises an electronic batch recording system, an MES system and an automatic equipment system; the electronic batch recording system comprises: the system comprises a design module, an execution module, a review module, an account management module, an electronic signature module and a material flow module; the MES system comprises: the system comprises a bill of material module, a formula management module, a scheduling management module, a work order management module, a quality management module, a deviation processing module, a weighing module and an equipment management module; the automation equipment system comprises an information receiving and processing module and automation equipment.
The MES system receives the production task, processes the production task to obtain production information and transmits the production information to the electronic batch recording system and the automatic equipment system; the automatic equipment system transmits actual production data acquired in production to the MES system and the electronic batch recording system; the MES system processes the actual production data and then transmits the actual production data to the electronic batch recording system for a decision maker to check and process;
the electronic batch recording system complies with FDA and GMP specifications, designs the whole process rules and SOPs into the system in an electronic mode, guides and controls operators or PLC (programmable logic controllers) to control operation to execute production tasks strictly according to the process rules, and specifically comprises the following modules:
designing a module: for designing electronic master batch records and complying with FDA-GMP manufacturing standards and ISA 88 standards;
an execution module: managing a human-machine interface of the whole execution process of the production instruction according to the dynamic processing tree;
a review module: providing a checking function for the electronic batch records, providing an electronic signature and accelerating the release of the batch, and using the electronic signature and the batch as a whole execution system for checking;
the automatic equipment system comprises an information receiving and processing module and automatic equipment; the information receiving and processing module is used for receiving and processing the production information, converting the production information into a production instruction, transmitting the production instruction to the automation equipment for producing the Danshu soft capsules, and collecting and storing actual production data acquired by the automation equipment;
the electronic batch record design, the electronic batch record execution and the electronic batch record audit in the electronic batch record system are as follows:
electronic batch record design: designing a main batch record, and designing the whole process procedure and SOPs;
electronic batch record execution: supporting an operator in a production work order by displaying a manufacturing guide; ensure data collection and associated production labeling; control the execution of various manufacturing tasks; managing deviation in real time; automatically generating batch records;
and (4) electronic batch record auditing: the method mainly comprises the following steps: deviation processing, family tree checking, audit tracking, weighing report and electronic batch record approval and release;
the electronic batch recording system lists all deviations in batch production, and requires quality personnel to process and electronically sign one by one.
The automatic equipment comprises a soft capsule pill press, a batching tank, a gelatin melting tank, a combined double-layer drying rotating cage, a heat-preservation gelatin storage barrel, an automatic box packing machine, an aluminum-plastic packaging machine, a pill selecting machine and a pillow packing machine;
the electronic batch recording system also comprises an account management module, an electronic signature module and a material flow module;
the account management module provides role-based access control; the authority is given to the role, and different roles can have partially same authority; and providing an electronic signature in compliance with the requirements; and providing access control audit trails;
the electronic signature of the activity or operation of the electronic signature module is bound with the authority, and whether a signer is authorized to confirm the related activity or operation is identified; the electronic signature module comprises the following signature types:
single label: if the user role of the signer can not meet the preset authority requirement of the signature, the signature fails;
double sticks: if the user role of the signer can not completely meet the preset authority requirement of the signature, the system pops up a second signature box for the second signer to sign so as to meet the authority requirement;
and (4) single-label checking: the signer must be inconsistent with the user logging into the system;
double-label checking: the signature must be done by both signers together;
the preset authority of the single-signature and double-signature electronic signature types can set different signature failure alarm levels; the alarm level is divided into: if the preset authority of the signature is not satisfied, the system automatically generates and records an alarm according to the set alarm level;
the material flow module comprises a material definition unit, a warehouse management unit, a weighing and batching unit, a material centralizing unit, a feeding operation unit and an output statement unit;
the material definition unit includes:
defining basic attributes: material codes, names, specifications, material types, stock units and packaging units, standard titer, standard density and ingredient loss rate;
weighing attribute definition: whether distribution weighing is allowed or not, whether manufacturing weighing is allowed or not, whether packaging weighing is allowed or not, distribution weighing precision, manufacturing weighing precision, a standard weighing work center, weighing batch management, weighing mixed batch control, weighing supplier batch mixed batch control and weighing mode selection;
batch/warehouse attribute definition: the method comprises the following steps of (1) receiving a default state of a material batch, whether the batch allows automatic materials or not, the validity period of the batch, the re-inspection period of the batch, reminding of the allowance of the finished batch, the minimum inventory, ABC codes of inventory, the storage attribute of the materials, a priority storage area for batch receiving, an overflow bulk storage area, a material receiving position, a sampling area, the expiration period of bottle opening and material labeling rules;
the hazard/prevention attribute defines: danger warning and precautionary measure prompt of materials, dangerous goods GHS icon and material processing prompt information;
extended annotation attribute definition: defining the expansion aiming at the material attribute in the project engineering;
the electronic batch recording system realizes the synchronization of system material definition and ERP material definition through a standard enterprise integration interface;
the warehouse management unit includes:
preparing a warehouse: storage medium definition for supporting materials in warehouse preparation, warehouse location, warehouse area and section definition, work center definition and delivery path definition;
batch receiving: the batch receipt is created through an enterprise integration interface or manually. The warehouse operator performs sub-packaging of the materials according to the actual material batch-to-cargo packaging mode, and the system automatically prints material packaging bar code labels;
sampling: after receiving the material batch, the system automatically generates a minimum package sampling list according to a material sampling rule;
and (3) batch release: after the batch inspection result is obtained, batch release work is executed, and batch release information is synchronized to the ERP system through the enterprise integration interface;
warehouse operation: supporting daily operations of the warehouse through a mobile client, wherein the daily operations comprise material group support, pallet merging/splitting, inventory movement and inventory information query;
inventory checking: support periodic inventory;
automatically picking materials according to batches: after the production work order is created, automatically generating a warehouse material receiving request according to a bill of materials;
material taking and ex-warehouse: creating a material receiving list, scanning a material bar code according to the material receiving list by a warehouse manager, and printing the material receiving list;
warehouse management audit trail;
the electronic batch recording system synchronizes information with an ERP or an external warehouse management system through an enterprise integration interface;
the weighing and batching unit is internally provided with a plurality of communication protocol drivers of common electronic scale brands and can be directly connected with an electronic scale for use;
the material centralizing unit performs centralized operation on the weighed materials and the materials before feeding;
the feeding operation unit prepares feeding according to the stage/sequence/dosage range of the work order.
The output statement unit uses the master batch record modeling label to prepare an output statement, and the output statement comprises a product code, a product batch state, whether a bar code label is printed or not, a batch production date, an output quantity, a production unit, whether ERP uploads output or not, whether output is in equipment or not, the quantity of output packages, the types of packages and the output positions.
The MES system comprises a material list module, a formula management module, a scheduling management module, a work order management module, a quality management module, a deviation processing module, a weighing module and an equipment management module;
the bill of material module comprises effective time, state, auditors and the number of formula units; the materials in the BOM comprise information such as the input sequence, whether weighing is needed, the input stage, the unit quantity and the like;
the formula management module is used for creating, viewing and modifying a formula;
the scheduling management module is used for reading the production data from the ERP enterprise management system and automatically decomposing the production data into daily batch work orders according to the ERP enterprise management system; automatically generating work orders in batches according to a predefined product production period template;
the work order management module is used for tracking the production process, and managing a system and requiring an operator to process a corresponding work flow in each production stage;
the quality management module is used for creating an inspection document for the to-be-inspected material in the raw and auxiliary material warehouse according to a sampling rule, making batch quality judgment according to an inspection result and communicating the judgment result to the WMS system; reading process and environment quality data, and giving batch quality results according to a judgment standard; creating an inspection bill for the semi-finished product and the finished product, and judging the quality according to an inspection structure;
the deviation processing module is used for automatically generating deviation under the condition that the expected design of the production information is not accordant, and the deviation is processed by predefined related personnel and finally audited by QA; the deviation processing module comprises the following three processing modes:
circulation mode: after the deviation appears, circularly executing the step of generating the deviation again;
a stop mode: after the deviation appears, prohibiting any production operation until QA finishes the deviation processing;
yielding execution mode: after the deviation appears, the production is continuously executed, and QA synchronously processes the deviation;
the weighing module is characterized in that: acquiring relevant weight data of raw materials, materials and intermediate materials in the production of the Danshu soft capsule, and transmitting the relevant weight data to the quality management module, the electronic batch recording system and the ERP system;
the device management module specifically comprises:
equipment account/card management;
equipment maintenance cycle management;
creating a maintenance plan, reminding due, and inputting a maintenance result;
managing equipment faults;
sudden fault maintenance, reason analysis, maintenance result input and spare part replacement;
device movement and location management;
CIP/SIP state change control management of the equipment;
managing the calibration state and the expiration date of the weighing instrument;
management of accessory devices of the device;
managing the occupied state of the materials and the types and the quantity of the materials in the equipment;
management of device capacity and related attributes;
managing the circulation times of the finite state;
and (5) material transfer premise management between devices.
The MBR module systematically manages key parameters of the production process, the process instruction flow is kept unchanged, and the process parameters can be adjusted according to an actual production plan.
The MBR module provides the functionality that a user can systematically manage key parameters (process parameters or equipment recipes) of a production process. The process instruction parameters can be set with fixed values in the process instruction or collected from an external system, and a user can prepare different MBRs according to different products or different product specifications. Namely, the process instruction flow is maintained unchanged, but the process parameters can be adjusted according to the actual production plan, namely, aiming at the condition that the process flows are consistent, but the parameter settings are different due to different product yields or specifications, the process flows are consistent, and the MES allows the same process instruction to correspond to different MBR settings due to different product yields, pilot tests or process equipment verification, so that the same process instruction is allowed to correspond to different MBR settings, the engineering quantity is simplified, and the verification work is reduced. After the MBR is executed, an execution report can be obtained, so that a user can compare an expected parameter with an actual parameter value conveniently.
The enterprise integration interface supports data upload (from the XSI database to an external system) and download (from an external system to the XSI database) streams. Built in with a standard connector that has been validated. The upload connector is responsible for transferring data from the electronic batch system core system to the XSI database, and the download connector is responsible for transferring data objects from the XSI database to the electronic batch system core system. Custom connectors may be formulated in the project.
An automatic production method of Danshu soft capsules, which applies a production control system of Danshu soft capsules, comprises the following steps: the automatic production control system comprises an electronic batch recording system, an MES system and an automatic equipment system; the MES system receives the production task, processes the production task to obtain production information and transmits the production information to the electronic batch recording system and the automatic equipment system; the automatic equipment system transmits actual production data acquired in production to the MES system and the electronic batch recording system; the MES system processes the actual production data and then transmits the actual production data to the electronic batch recording system for a decision maker to check and process;
the electronic batch recording system complies with FDA and GMP specifications, designs the whole process rules and SOPs into the system in an electronic mode, guides and controls operators or PLC (programmable logic controllers) to control operation to execute production tasks strictly according to the process rules, and specifically comprises the following modules:
designing a module: for designing electronic master batch records and complying with FDA-GMP manufacturing standards and ISA 88 standards;
an execution module: managing a human-machine interface of the whole execution process of the production instruction according to the dynamic processing tree;
a review module: providing a checking function for the electronic batch records, providing an electronic signature and accelerating the release of the batch, and using the electronic signature and the batch as a whole execution system for checking;
the automatic equipment system comprises an information receiving and processing module and automatic equipment; the information receiving and processing module is used for receiving and processing the production information, converting the production information into a production instruction, transmitting the production instruction to the automation equipment for producing the Danshu soft capsules, and collecting and storing actual production data acquired by the automation equipment.
Finally, the above embodiments are only for illustrating the technical solutions of the present invention and not for limiting, although the present invention has been described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions may be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all of them should be covered in the claims of the present invention.
Claims (10)
1. An automatic production method of Danshu soft capsules is characterized by comprising a gelatin melting process, and specifically comprises the following steps:
s1: mixing ethyl p-hydroxybenzoate, 95% alcohol, water, glycerol, gelatin, sorbitol and polysorbate 80 as raw materials of the Danshu soft capsule to obtain a premixed material I;
s2: adding the raw materials of the Danshu soft capsule into a gelatin melting tank for gelatin melting to obtain a mixed gelatin solution II;
s3: recording the waste material III in the step;
the weighing module acquires the mass of the premixed material I, the mass of the mixed glue solution II and the mass of the waste material III, and transmits mass data to the mass management module to calculate the material yield and the material balance rate; the material yield is performed downwards when the yield is between 90.0 and 100.0 percent, and deviation is not generated when the yield is between 90.0 and 100.0 percent; the material balance rate is carried out downwards when being 92.0-100.0%, and deviation is not generated when being 92.0-100.0%; the quality management module transmits the deviation to a deviation management module; the deviation management module stores and displays the deviation, receives a command for processing the deviation and transmits the command to an automatic equipment system;
the calculation formula of the material yield is as follows:
the formula for calculating the material balance rate is as follows:
2. the automated production method according to claim 1, wherein the automated equipment system includes an information reception processing module and automated equipment; the information receiving and processing module is used for receiving and processing production instruction information, transmitting the production instruction information to the automation equipment, and collecting and storing actual production information acquired by the automation equipment.
3. The automated production method according to claim 1, further comprising a pellet pressing and selecting process, specifically comprising the steps of:
1) putting the mixed glue solution II and the mixed liquid medicine of the corn oil and the peppermint oil into a soft capsule pelleting press for pelleting;
2) selecting the soft capsule pills produced in the step 1),
and the quality management module acquires the process parameters and the loading condition in production every half hour, compares the process parameters and the loading condition with a standard data range, generates deviation if the process parameters and the loading condition are not in the standard range, and reports the deviation to the deviation management module for processing.
4. An automatic production control system for Danshu soft capsules is characterized by comprising an electronic batch recording system, an MES system and an automatic equipment system; the MES system receives the Danshu soft capsule production task, processes the Danshu soft capsule production task to obtain production information and transmits the production information to the electronic batch recording system and the automatic equipment system; the automatic equipment system transmits actual production data obtained in the Danshu soft capsule production to the MES system and the electronic batch recording system; the MES system processes the actual production data and then transmits the actual production data to the electronic batch recording system for a decision maker to check and process;
the electronic batch recording system complies with FDA and GMP specifications, electronically designs the whole technical specification of the Danshu soft capsules and SOPs into the system, guides and controls operators or PLC (programmable logic controller) to control operation to strictly execute production tasks according to the technical specification, and specifically comprises the following modules:
designing a module: for designing electronic master batch records and complying with FDA-GMP manufacturing standards and ISA 88 standards;
an execution module: managing a human-machine interface of the whole execution process of the production instruction according to the dynamic processing tree;
a review module: providing a checking function for the electronic batch records, providing an electronic signature and accelerating the release of the batch, and using the electronic signature and the batch as a whole execution system for checking;
the automatic equipment system comprises an information receiving and processing module and automatic equipment; the information receiving and processing module is used for receiving and processing the production information, converting the production information into a production instruction, transmitting the production instruction to the automation equipment for producing the Danshu soft capsules, and collecting and storing actual production data acquired by the automation equipment.
5. The automated production control system of claim 4, wherein electronic batch record design, electronic batch record execution, and electronic batch record review in the electronic batch record system are as follows:
electronic batch record design: designing a main batch record, and designing the whole process procedure and SOPs;
electronic batch record execution: supporting an operator in a production work order by displaying a manufacturing guide; ensure data collection and associated production labeling; control the execution of various manufacturing tasks; managing deviation in real time; automatically generating batch records;
and (4) electronic batch record auditing: the method mainly comprises the following steps: deviation processing, family tree checking, audit tracking, weighing report and electronic batch record approval and release;
the electronic batch recording system lists all deviations in batch production, and requires quality personnel to process and electronically sign one by one.
6. The automated production control system of claim 4, wherein the automated equipment comprises a soft capsule pelleting machine, a dispensing tank, a glue melting tank, a combined double-layer drying rotating cage, a heat-preservation glue storage barrel, an automatic boxing machine, an aluminum-plastic packaging machine, a pill selecting machine and a pillow packaging machine.
7. The automated production control system of claim 4, wherein the electronic batch recording system further comprises an account management module, an electronic signature module, a material flow module;
the account management module provides role-based access control; the authority is given to the role, and different roles can have partially same authority; and providing an electronic signature in compliance with the requirements; and providing access control audit trails;
the electronic signature of the activity or operation of the electronic signature module is bound with the authority, and whether a signer is authorized to confirm the related activity or operation is identified; the electronic signature module comprises the following signature types:
single label: if the user role of the signer can not meet the preset authority requirement of the signature, the signature fails;
double sticks: if the user role of the signer can not completely meet the preset authority requirement of the signature, the system pops up a second signature box for the second signer to sign so as to meet the authority requirement;
and (4) single-label checking: the signer must be inconsistent with the user logging into the system;
double-label checking: the signature must be done by both signers together;
the preset authority of the single-signature and double-signature electronic signature types can set different signature failure alarm levels; the alarm level is divided into: if the preset authority of the signature is not satisfied, the system automatically generates and records an alarm according to the set alarm level;
the material flow module comprises a material definition unit, a warehouse management unit, a weighing and batching unit, a material centralizing unit, a feeding operation unit and an output statement unit.
8. The automated production control system according to claim 7, wherein the material definition unit includes:
defining basic attributes: material codes, names, specifications, material types, stock units and packaging units, standard titer, standard density and ingredient loss rate;
weighing attribute definition: whether distribution weighing is allowed or not, whether manufacturing weighing is allowed or not, whether packaging weighing is allowed or not, distribution weighing precision, manufacturing weighing precision, a standard weighing work center, weighing batch management, weighing mixed batch control, weighing supplier batch mixed batch control and weighing mode selection;
batch/warehouse attribute definition: the method comprises the following steps of (1) receiving a default state of a material batch, whether the batch allows automatic materials or not, the validity period of the batch, the re-inspection period of the batch, reminding of the allowance of the finished batch, the minimum inventory, ABC codes of inventory, the storage attribute of the materials, a priority storage area for batch receiving, an overflow bulk storage area, a material receiving position, a sampling area, the expiration period of bottle opening and material labeling rules;
the hazard/prevention attribute defines: danger warning and precautionary measure prompt of materials, dangerous goods GHS icon and material processing prompt information;
extended annotation attribute definition: defining the expansion aiming at the material attribute in the project engineering;
the electronic batch recording system realizes the synchronization of system material definition and ERP material definition through a standard enterprise integration interface;
the warehouse management unit includes:
preparing a warehouse: storage medium definition for supporting materials in warehouse preparation, warehouse location, warehouse area and section definition, work center definition and delivery path definition;
batch receiving: the batch receipt is created through an enterprise integration interface or manually. The warehouse operator performs sub-packaging of the materials according to the actual material batch-to-cargo packaging mode, and the system automatically prints material packaging bar code labels;
sampling: after receiving the material batch, the system automatically generates a minimum package sampling list according to a material sampling rule;
and (3) batch release: after the batch inspection result is obtained, batch release work is executed, and batch release information is synchronized to the ERP system through the enterprise integration interface;
warehouse operation: supporting daily operations of the warehouse through a mobile client, wherein the daily operations comprise material group support, pallet merging/splitting, inventory movement and inventory information query;
inventory checking: support periodic inventory;
automatically picking materials according to batches: after the production work order is created, automatically generating a warehouse material receiving request according to a bill of materials;
material taking and ex-warehouse: creating a material receiving list, scanning a material bar code according to the material receiving list by a warehouse manager, and printing the material receiving list;
warehouse management audit trail;
the electronic batch recording system synchronizes information with an ERP or an external warehouse management system through an enterprise integration interface;
the weighing and batching unit is internally provided with a plurality of communication protocol drivers of common electronic scale brands and can be directly connected with an electronic scale for use;
the material centralizing unit performs centralized operation on the weighed materials and the materials before feeding;
the feeding operation unit prepares feeding according to the stage/sequence/dosage range of the work order;
the output statement unit uses the master batch record modeling label to prepare an output statement, and the output statement comprises a product code, a product batch state, whether a bar code label is printed or not, a batch production date, an output quantity, a production unit, whether ERP uploads output or not, whether output is in equipment or not, the quantity of output packages, the types of packages and the output positions.
9. The automated production control system of claim 4, wherein the MES system comprises a bill of materials module, a recipe management module, a schedule management module, a work order management module, a quality management module, a deviation processing module, a weighing module, an equipment management module, an MBR module;
the bill of material module comprises effective time, state, auditors and the number of formula units; the materials in the BOM comprise information such as the input sequence, whether weighing is needed, the input stage, the unit quantity and the like;
the formula management module is used for creating, viewing and modifying a formula;
the scheduling management module is used for reading the production data from the ERP enterprise management system and automatically decomposing the production data into daily batch work orders according to the ERP enterprise management system; automatically generating work orders in batches according to a predefined product production period template;
the work order management module is used for tracking the production process, and managing a system and requiring an operator to process a corresponding work flow in each production stage;
the quality management module is used for creating an inspection document for the to-be-inspected material in the raw and auxiliary material warehouse according to a sampling rule, making batch quality judgment according to an inspection result and communicating the judgment result to the WMS system; reading process and environment quality data, and giving batch quality results according to a judgment standard; creating an inspection bill for the semi-finished product and the finished product, and judging the quality according to an inspection structure;
the deviation processing module is used for automatically generating deviation under the condition that the expected design of the production information is not accordant, and the deviation is processed by predefined related personnel and finally audited by QA; the deviation processing module comprises the following three processing modes:
circulation mode: after the deviation appears, circularly executing the step of generating the deviation again;
a stop mode: after the deviation appears, prohibiting any production operation until QA finishes the deviation processing;
yielding execution mode: after the deviation appears, the production is continuously executed, and QA synchronously processes the deviation;
the weighing module is characterized in that: acquiring relevant weight data of raw materials, materials and intermediate materials in the production of the Danshu soft capsule, and transmitting the relevant weight data to the quality management module, the electronic batch recording system and the ERP system;
the device management module specifically comprises:
equipment account/card management;
equipment maintenance cycle management;
creating a maintenance plan, reminding due, and inputting a maintenance result;
managing equipment faults;
sudden fault maintenance, reason analysis, maintenance result input and spare part replacement;
device movement and location management;
CIP/SIP state change control management of the equipment;
managing the calibration state and the expiration date of the weighing instrument;
management of accessory devices of the device;
managing the occupied state of the materials and the types and the quantity of the materials in the equipment;
management of device capacity and related attributes;
managing the circulation times of the finite state;
performing material transfer premise management between devices;
the MBR module systematically manages key parameters of the production process, the process instruction flow is kept unchanged, and the process parameters can be adjusted according to an actual production plan.
10. An automatic production method of Danshu soft capsules, which is applied to the automatic production control system of Danshu soft capsules according to any one of claims 4 to 9, the method comprising: the automatic production control system comprises an electronic batch recording system, an MES system and an automatic equipment system; the MES system receives the production task, processes the production task to obtain production information and transmits the production information to the electronic batch recording system and the automatic equipment system; the automatic equipment system transmits actual production data acquired in production to the MES system and the electronic batch recording system; the MES system processes the actual production data and then transmits the actual production data to the electronic batch recording system for a decision maker to check and process;
the electronic batch recording system complies with FDA and GMP specifications, designs the whole process rules and SOPs into the system in an electronic mode, guides and controls operators or PLC (programmable logic controllers) to control operation to execute production tasks strictly according to the process rules, and specifically comprises the following modules:
designing a module: for designing electronic master batch records and complying with FDA-GMP manufacturing standards and ISA 88 standards;
an execution module: managing a human-machine interface of the whole execution process of the production instruction according to the dynamic processing tree;
a review module: providing a checking function for the electronic batch records, providing an electronic signature and accelerating the release of the batch, and using the electronic signature and the batch as a whole execution system for checking;
the automatic equipment system comprises an information receiving and processing module and automatic equipment; the information receiving and processing module is used for receiving and processing the production information, converting the production information into a production instruction, transmitting the production instruction to the automation equipment for producing the Danshu soft capsules, and collecting and storing actual production data acquired by the automation equipment.
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| CN112859778A (en) * | 2021-01-06 | 2021-05-28 | 辽宁华润本溪三药有限公司 | Quality management method and system for traditional Chinese medicine production process |
| CN114767537A (en) * | 2022-03-29 | 2022-07-22 | 正大制药（青岛）有限公司 | Soft capsule automatic production line based on material net |
| CN116894510A (en) * | 2023-06-06 | 2023-10-17 | 扬州云易信息技术有限公司 | MES-based multifunctional regulation and control production system |
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