Analysis on the implementation of automatic control system for clean room in pharmaceutical factories

The pharmaceutical industry is related to life and health. The stability and compliance of its production environment, clean rooms, is the lifeline of drug quality and safety. Small fluctuations in environmental parameters such as temperature, humidity, pressure difference, and dust particle count may directly affect the purity, potency of drugs and even the success or failure of production batches. Therefore, the automated control system serving pharmaceutical factories is far from ordinary building automation. It is a set of precision engineering that combines process understanding, strict compliance and high reliability requirements.

In recent years, with the continuous upgrading of GMP standards in the domestic pharmaceutical industry and the vigorous development of biopharmaceutical and innovative pharmaceutical industries, the construction of pharmaceutical industrial parks in East China coastal areas, central China, southwest and other places is in full swing. When building or renovating factories, many pharmaceutical companies are faced with the challenge of how to build or upgrade a set of automatic control systems that can not only meet strict regulatory requirements, but also improve production flexibility and reduce energy consumption. Common concerns include: How does the system meet FDA or EU GMP requirements for data integrity and audit trails? How to achieve accurate and stable control of pressure differences between areas with different clean levels? When process equipment (such as sterilization cabinets and freeze-drying machines) is frequently started and stopped, how can the automatic control system respond quickly to maintain environmental stability?

To answer these questions, we need to go deep into the core scenarios of pharmaceutical production. Take the project of a well-known biopharmaceutical company in East China that Shanghai Ruikongyuan Intelligent Technology participated in as an example. The core of this project is to build an antibody drug production line that meets international standards, which has extremely high requirements for clean room environmental control. The first key point facing the project team is the compliance design of the control strategy. The automatic control system must not only realize control functions, but all data generated by it, including setting value modifications, alarm records, operator login logs, etc., must comply with the ALCOA+ principle of electronic record reliability (traceability, clarity, synchronization, original, accurate). This means that everything from controller selection to software platform to data storage architecture requires targeted design. Based on their understanding of mainstream industrial control platforms such as Hollysys and Siemens, the Sinkongyuan technical team customized a data management solution for customers that meets the requirements of 21 CFR Part 11 electronic signature regulations, ensuring the credibility of data across the entire chain from production to supervision.

The second core is control accuracy and stability in complex environments. The pharmaceutical clean room is a dynamic balancing system. Personnel entry and exit, material transfer, and process equipment operation can interfere with the environment. For example, heat is generated when the filling line is started, requiring the air conditioning system to quickly replenish cold; when the Class A laminar flow hood is turned on, the air supply needs to be adjusted to ensure the wind speed and cleanliness of the operating table. This requires the automatic control system to have fast and accurate feedback adjustment capabilities. During the implementation of the project, the team used high-precision sensors and a DDC controller with faster response speed, and wrote an advanced feedforward-feedback compound control algorithm. When important process equipment status signals are connected to the system, the control system can predict environmental load changes in advance and adjust the water valve opening or fan frequency in advance, thereby suppressing environmental fluctuations to a minimum range and significantly improving production stability and batch consistency.

The third aspect that cannot be ignored is system verification (V&V) services. For pharmaceutical projects, installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) of the automatic control system are necessary parts of project delivery and are also the cornerstone for pharmaceutical companies to pass official audits. This part of the work is highly professional and requires high documentation requirements, and requires the technical service provider to understand both technology and regulations. Relying on its experience in serving multiple pharmaceutical companies, Ruikongyuan has formed a standardized verification support process, which can assist customers in preparing verification plans, performing tests, and issuing reports, greatly reducing the burden on the pharmaceutical company's engineering department and accelerating the project's production process.

In addition to high-standard biopharmaceutical projects, automatic control systems also play a key role in the energy efficiency improvement and transformation of some large traditional Chinese medicine preparations or chemical pharmaceutical companies in Central China. By integrating and linking the original independently operating air conditioning units, cold water systems, and lighting systems, and introducing an energy management platform based on real-time data, companies can clearly see energy consumption data in different workshops and different periods of time. The system can automatically switch to the energy-saving operation mode according to the production plan, reducing the number of air changes in the clean room and the temperature and humidity control accuracy requirements during non-production periods, thereby achieving significant energy-saving effects, which is in line with the country's development orientation for green manufacturing in the industrial field.

It can be seen from these practices that the successful construction of automatic control systems in pharmaceutical factories is a process that deeply integrates process knowledge, automation technology, compliance requirements and project management. It requires technical service providers to be not just an equipment supplier or programming debugging party, but must be partners who can deeply understand the characteristics of the industry and provide customized comprehensive solutions. Shanghai Ruikongyuan Intelligent Technology is positioned here. Its differentiated advantage lies in having a technical team that can complete the entire process from demand analysis, compliance design, programming debugging to verification support. As an authorized distributor of well-known brands such as Hangzhou Meiyi Automation, it can integrate high-quality product resources, but its more core value lies in its engineering ability to transform products into stable, compliant and efficient solutions.

With the deepening of "Made in China 2025" and intelligent manufacturing in the pharmaceutical field, the automatic control system is moving from a single environmental guarantee role to a deep integration with MES (Manufacturing Execution System) and LIMS (Laboratory Information Management System) to realize the digitization and visualization of the entire production process. This has put forward new requirements for pharmaceutical companies and automatic control technology service providers. Selecting partners with continuous learning capabilities, technology integration capabilities, and rich industry implementation cases will help pharmaceutical companies gain efficiency and cost advantages on the track of ensuring quality compliance.