In recent years, global regulations have placed increasingly stringent requirements on the pharmaceutical industry, and the digitalization of pharmaceutical production processes and traceability have become a major trend in industry upgrades. To enhance their own competitiveness, traditional pharmaceutical companies have also launched digital transformation of pharmaceutical production and the improvement of intelligent manufacturing.

In order to realize the transformation and upgrading of intelligent manufacturing, the Chinese medicine formula granule preparation workshop of a pharmaceutical company built the preparation workshop as the intelligent manufacturing of Chinese medicine formula granules as the ten-point benchmark for the company's intelligent production workshop, realized the deep integration of OT/IT, and realized data interconnection, so as to achieve the purpose of improving management level, product quality and production efficiency.

The implementation of the overall intelligent manufacturing solution of this project is based on the SOLISCADA system, which realizes the interconnection of equipment and data collection to achieve a unified data layer, providing a data foundation for the information level, and connecting the upper and lower levels.

The production process of the preparation workshop involves multiple links such as feeding, mixing, granulation, internal packaging, external packaging, etc., as well as equipment such as palletizing and warehousing. 

In the traditional production model, all equipment is in a data island, equipment and production data cannot be collected uniformly, data is difficult to trace back, production data needs to be entered manually, and equipment status cannot be perceived in time. Computer verification poses more challenges to the entire production process. 

Therefore, the first step of this project is to realize data collection and monitoring of all equipment through the SOLISCADA system, digitally record the production process, and realize audit tracking of the entire production process.

System architecture

Redundant SCADA data servers are deployed to realize network data collection for 6 processes and 40 devices in all workshops. Data collection protocols include S7 protocol, Modbus protocol, 232 custom protocol, HTTP and other methods to realize device communication.

The operator station monitors process data and controls equipment during the production process. It also integrates camera images so that when control instructions are issued, the actual operating status of the equipment can be observed in real time through the camera.

Through the firewall, SCADA data is opened to the information network, and data interconnection and interoperability with the MES system and the digital twin system are achieved, data upload is realized, and production recipe instructions from the MES system are received and sent to the equipment PLC to realize production control.





Functionalities

·Process data recording

Through data collection and storage, the process data of all links can be recorded and archived, including trend data, alarm data, operation log data, recipe data, etc. The data is stored in encrypted form and cannot be tampered with or deleted.

·Electronic signature 

Electronic signature complies with GAMP regulations. Supports single signature, double signature, and setting system key operations to trigger electronic signature, including bit number writing value, alarm confirmation triggering electronic signature. Electronic signature can be configured through user permissions.

Electronic signature records are permanently encrypted and stored, cannot be tampered with, and can be backed up regularly. It provides convenient query and browsing functions, supports filtering queries such as operators, operated objects, behaviors, descriptions, and time, and facilitates users to quickly trace back and audit.

Set up electronic signatures in parameter distribution, report viewing and other links to record operation behaviors and achieve audit tracking.

·Data transmission

As a data middle platform, SOLISCADA system collects PLC data from equipment on the one hand, and provides data to the upper-level production management information system on the other hand to realize electronic batch records of production. 

At the same time, it is also a channel for the upper-level production management information system to issue production recipe instructions, realize equipment control, execute production, and achieve integrated management and control.

·Equipment OEE Analysis

The SCADA system automatically records equipment information of startup/shutdown, equipment performance data, and combines it with product qualification rate to realize automatic calculation of equipment OEE, timely feedback on equipment operating efficiency, analyze the reasons for equipment capacity loss, and provide a scientific basis for production management to optimize the production management process, thereby improving equipment operating efficiency and ultimately improving productivity and product quality.

·Process parameter analysis

The SCADA system records the process data and formula data of each batch of the same product. Combined with the product quality data, comparative analysis of process parameters between batches is performed to derive the best batch parameters and provide data reference for process optimization.

Monitoring screen

 Alarm screen

Real-time alarm screen

Historical alarm screen

Equipment OEE Analysis

The SCADA system of this project comprehensively collects and centrally controls data of the entire production process, which is the basis for the digital transformation of production. 

The SCADA system is connected with the MES system data to realize the integrated control of the production process, so that the traditional manual data recording method is converted into automated recording, which improves the accuracy of production batch data, avoids data errors and human tampering, and makes the drug production process traceable, strengthening the quality assurance of the production process. 

Through the automated data collection and comprehensive analysis of the data, the production process can be improved, the efficiency can be improved, and more value can be created for the enterprise.