First, advanced design concept
This solution is based on the advanced process control system SIMATIC PCS 7 design. It refers to the advanced concept of real-time release testing in the new version of GMP drug production quality management specifications and the implementation of the product life cycle proposed by the International Society of Pharmaceutical Engineering (ISPE) to establish the entire process quality of pharmaceutical production. The monitoring system realizes the quality management of the whole production process from raw materials to finished products, makes the pharmaceutical production process digital and standardized, and has data traceability and early warning functions, and comprehensively improves the quality control level of pharmaceutical production.
Second, rich experience in pharmaceutical automation construction
Our company has a complete process research department, design technology department, engineering implementation department, and professional engineering installation department. It has a professional engineering service team. The employees have many years of experience in the design and construction of the pharmaceutical industry. Our design and implementation personnel have Participated in the completion of more than 100 pharmaceutical automatic control projects, with sufficient design and implementation experience, and can provide users with professional engineering services.
Third, a complete new version of GMP computer certification solutions and experience
Our company has a complete solution and a full set of verification documents for computer verification in GMP, and has developed a computer system verification (CSV) based on risk assessment (RA) in accordance with the guidelines of the International Society of Pharmaceutical Engineering GAMP5 (Management Practice for Production Automation) template. Has helped many companies to pass relevant verifications, and our company can provide full assistance in the later GMP certification process of your company. Combine our design experience and user requirements to realize the full-process automation control of various monomer equipment in the pharmaceutical workshop, complete the control system architecture network design, process design, control plan and process control design. The control program is fully in line with the single-line operation of the product process, and the internal design of each product process is modularized. The logical relationship and real-time release principle of each control module are clearly defined between each process to realize the entire process control of the entire production line. Improve the stability of the pharmaceutical production process, realize continuous production, the production process meets GMP requirements, ensure the integrity of pharmaceutical production data, improve production management and production efficiency, save labor costs, save energy and reduce consumption, and improve product quality.
Design Principles
The automatic control system of this project uses computer control technology to enable scientific, effective and strict monitoring and control of the process operations and parameters of pharmaceutical production, and realize the continuity and automation of pharmaceutical production. The design process needs to consider the following points:
The overall design needs to consider the overall structure of the intelligent workshop. On the basis of the process design, equipment selection control and production control of the first and second levels of equipment control, fully consider the strategic requirements of the third level of informatization. On the basis of the reserved communication interface, the control layer of the bottom device considers the standard connection of the upper and lower levels, and prepares for the corresponding data connection in advance.
The design of the control system production line starts from the process, and understands the overall production process flow and the design of the overall automated production line to ensure that the automation system software design is based on process production, thereby ensuring the smooth use and operation of the production system.
The design scheme must reflect the advanced nature, modularity, reliability, ease of operation, and ease of maintenance.
All design and material selection must comply with the principles of reasonableness, applicability, reliability, durability, economy, energy saving, advanced, safe and easy operation.
Design, supply, install and debug in strict accordance with relevant national regulations and technical standards.
The design unit prepares the verification plan and verification report, and meets the GMP confirmation requirements to assist in passing the GMP verification.
Improve market competitiveness: Through the application of advanced pharmaceutical equipment and its automatic control technology, the technical level of products has been improved, product quality and output have been greatly improved, and the market competitiveness of products has been improved.
Quality Assurance: In response to user needs, there are product qualification certificates or imported products manufacturer certification.
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