I. Project Overview

With the continuous expansion of enterprise scale and product diversification, improve process operation and process control, fully tap the potential of technology and management to create better economic benefits, to achieve the management and decision-making of the automatic dosage system and scientific and increasingly important, automatic dosage system technology and the application of information technology, is the urgent need for the development of pharmaceutical enterprises.

This project for the biological chemical process key industrial equipment or industrial processes, such as fermentation tanks, reaction kettles, extraction tanks, evaporators, etc., soft measurement, process control, process optimization, weighing and dosage system integration and engineering application of the summary of the refinement and assessment of the perfect, and ultimately the formation of a complete set of biochemical process special control weighing and dosage system, and the varieties of application implementation of the unit to get the unit of the equipment for the best economic benefits. Subsequently, the construction of production scheduling and production management weighing and dosage system, to achieve prescription management, batch production scheduling, production line management, batch tracking and safety management, the optimization of single-species production process, and further coordination of multi-species, to obtain the best overall economic benefits. Eventually, it establishes a plant-wide information weighing and dosing management system and realizes a comprehensive automatic dosing system.

Second, the main functions and technical indicators

Complete set of specialized feeding system for biological fermentation process.

(1) Bio-fermentation process parameter measurement system: fermentation process physical parameters such as fermentation tank temperature T, fermentation tank pressure P, fermentation liquid volume V, air flow rate FA, cooling water inlet and outlet temperatures T1 and T2, stirring motor rotation speed RPM, stirring motor current I, foam height H, etc.; fermentation process chemical parameters such as pH and dissolved oxygen concentration Do, etc.; biomass respiration and metabolism parameters, biomass concentration, metabolism product concentration, substrate concentration, and biological parameters of the fermentation process such as biomass growth rate, substrate consumption rate and product formation rate.

(2) Conventional control system for biofermentation process: defoaming control, tank temperature control, tank pressure control, pH control, dissolved oxygen control, replenishment control, etc.

(3) Bio-fermentation process modeling, advanced control and optimization: pH, reaction temperature optimization curve control, medium addition process optimization strategy, transfer process optimization strategy.

(2) Synthetic reaction process complete set of specialized systems. Aiming at the optimization of comprehensive economic indexes of intermittent production process, the system integrates intermittent production management and intermittent production process control into one intermittent control weighing and batching system. In addition to all the functions of the program batch control system, there are formula processing, process optimization, online or offline statistical process control, batch production management, planning and scheduling, energy management and other functions.

(3) Chinese medicine extraction process sets of special systems: modern Chinese medicine preparation process includes: herbs -> washing -> drying -> chopping -> water extraction three times -> filtration -> resin adsorption -> water washing -> elution -> decompression and concentration -> alcohol precipitation -> filtration -> decompression and concentration -> low-temperature drying or spray drying -> finished products; the production process of traditional Chinese medicine extraction is based on the GMP norms, according to the given formula, the production of a certain amount of products, is a typical process. Chinese medicine extraction production process is based on GMP specifications, according to the given formula, the production of a certain amount of product process, is a typical intermittent production process. Its main characteristics are: small batch, multi-species, characterized by: discontinuity of material flow, non-stationarity of materials and equipment, product and its process uncertainty and dynamic scheduling and allocation of equipment resources. Including Chinese medicine extraction process sequence control, discrete control, regulation control, recipe processing, equipment management, production scheduling and tracking functions, operation optimization.

(4) MES Manufacturing Execution Batching System: On the basis of process control, based on the integrated information platform of pharmaceutical enterprises with unstructured data management, it builds production scheduling and production weighing and batching management system, realizes prescription management, batch production scheduling, production line management, batch tracking and safety management, etc. It optimizes the production process of single varieties and further realizes coordination of multiple varieties to obtain the overall optimal economic efficiency.

(5) ERP Enterprise Resource Weighing and Batching Management System: Establish the whole plant information network weighing and batching system, realize the information exchange from sensors to meeting rooms, locate the data of any object by the object through the network, and integrate the plant into a unified whole from the process parameter detection to the business information weighing and batching system; realize the enterprise integrated automatic batching system, including: weighing control system, formula management system, Human Resource Management System, Integrated Department Management System, Sales Management System, Purchase Management System, Inventory Management System, Set Design Weighing and Batching System, Weighing and Batching Management System, Safety Management System, Master Production Plan, Coarse Capacity Plan, Material Requirement Plan, Fine Capacity Plan, Production Operation Control, Branch Factory Management, Process Control Integrated Application Weighing and Batching System.

Third, technological innovation

(1) Adopting advanced control, equipment modeling and process optimization technologies to realize complete sets of dedicated systems for biological fermentation process, complete sets of dedicated weighing for synthetic reaction process, and complete sets of dedicated batching for traditional Chinese medicine extraction process;

(2) Provide customizable and expandable pharmaceutical industry control engineering industry algorithm library, through design institutes, equipment manufacturers, engineering companies, industry users, constantly refining expert knowledge and engineering experience, constantly enriching the industry's professional knowledge base of automatic dosage system, the main body of the domain knowledge, in the reusable resources, weighing and dosage system under the support of the architectural platform of the system, on the basis of the unified modeling specifications, through inheritance, derivation, Reuse, reconfiguration mechanism, significantly improve the efficiency of project engineering design and programming development;

(3) Develop and implement a variety of network-driven hardware modules, adopt transparent network management technology to realize data communication with third-party equipments through open standard OPC client and server interfaces, build a distributed real-time database of engineering objects, realize global consistency and unified interfaces between data of weighing and feeding system and data of external equipments, and meet information integration and interface openness requirements of multi-real-time, multi-semantic, multi-spatio-temporal, multi-scalar industrial data; based on the unified modeling specification, it can significantly improve the efficiency of project engineering design and programming development through inheritance, derivation, and reconstruction mechanisms. Based on the real-time database, it realizes the network interconnection and data interface between the unit device and intelligent equipment of pharmaceutical enterprises.

Fourth, the application field and use effect

A pharmaceutical enterprise adopts centralized feeding system and its control engineering application software platform to realize comprehensive automatic dosage. First of all, the process control is carried out by varieties and units: complete the parameter detection and stable control of important production units such as fermentation tanks and reaction kettles, set up unit dosage control system, so that each process equipment can play the best benefit; including fermentation workshop, synthesis workshop, automatic dosage system renovation of thermal power plant, scientific research center, three-waste treatment, etc.; subsequently, build production scheduling and production management system to realize the management of prescriptions, batch production scheduling, production line management, batch tracking and safety management, etc., to optimize the production process of single varieties and further realize the coordination of multiple varieties; finally, to realize the enterprise integrated automatic batching system. After the implementation of integrated dosage, the production level of fermentation and post-extraction has been greatly improved; the rate of bacterial contamination has been further reduced; the consumption of main and auxiliary raw materials has also been reduced; the comprehensive cost of products has been reduced by more than 10% per year; the cost of raw material procurement has been reduced by more than 6% per year; the sales revenue has been increased by more than 20% per year; and the economic benefits have been remarkable.