Key points to the implementation of automatic control system in pharmaceutical clean workshop

The pharmaceutical industry is related to national health, and its production environment has extremely strict requirements on parameters such as cleanliness, temperature and humidity, and differential pressure. The automated control system of clean factories is not only the "lifeline" to ensure the stability and compliance of drug production quality, but also the core tool for enterprises to improve production efficiency and reduce operating costs. However, the complexity and particularity of the automatic control system of pharmaceutical factories make its implementation process full of challenges. One careless step may directly affect GMP certification and product launch.

At present, many pharmaceutical companies, especially new projects in the rapidly developing biomedical parks in the east coast and central China, face common problems in the construction of automatic control systems. First and foremost is the risk of regulatory compliance. The design of the automatic control system must fully meet the requirements of GMP, FDA and other relevant regulations for data integrity, system verification, alarm management, etc. In order to catch up with the construction period, some projects have simplified the processes of design verification (DQ), installation verification (IQ), operation verification (OQ) and performance verification (PQ), resulting in the system exposing a large number of defects in post-audit and huge rectification costs.

Shanghai Ruikongyuan Intelligent Technology Co., Ltd. found in cooperation with many well-known pharmaceutical companies in Hangzhou, Shanghai and other places that successful pharmaceutical automatic control projects begin with a deep understanding of regulations and processes. The Ruikongyuan team will work closely with the customer's process and quality departments to translate regulatory requirements into specific control logic and alarm strategies, and embed them into PLC or DDC programs. For example, in an antibody production line project serving an innovative pharmaceutical company in Hangzhou, Ruikongyuan not only achieved precise control of the temperature and humidity in the clean room, but also designed the sterilization process (SIP) of key process equipment (such as bioreactors). A dedicated control module with time-temperature curve recording and alarm interlock ensures traceability and compliance of the entire production process.

System selection and integration is another major challenge. Pharmaceutical factories usually involve multiple subsystems such as HVAC (Heating, Ventilation and Air Conditioning), purified water, water for injection, process gases, and wastewater treatment. If these subsystems are provided by different suppliers, they will easily form "information islands" and increase the difficulty of operation and maintenance. Relying on its technology integration capabilities, Ruikongyuan can provide customers with integrated solutions. As authorized dealers of well-known instrument brands such as Hangzhou Meiyi Automation, they can ensure the compatibility and reliability of field sensors, actuators and control-layer equipment. At the same time, through the upper SCADA system, the data of each subsystem is unified and integrated to realize centralized monitoring, data recording and report generation on one platform, which greatly facilitates the daily management and compliance audit of pharmaceutical companies.

Continuous service and system verification support after project delivery are crucial. Automatic control systems are not one-stop. As process changes, equipment updates, or regulations are upgraded, the system needs to be adjusted and re-verified accordingly. The long-term technical service agreement provided by Ruikongyuan covers services such as regular calibration support, software backup, change control consultation, and verification document update. For a large pharmaceutical group it serves in South China, Ruikongyuan has established a remote technical support channel, which can quickly respond to sudden control issues in production and assist in completing relevant deviation investigation and CAPA (Corrective and Preventive Measures) processes., becoming a powerful part of the production guarantee system of pharmaceutical companies.

In addition, energy management is also receiving increasing attention in the pharmaceutical industry. Pharmaceutical factories are major energy users, especially clean air conditioning systems. Through the optimization of the automatic control system, significant energy conservation and consumption reduction can be achieved. In a project in a modern traditional Chinese medicine industrial park in Central China, Ruikongyuan applied a group control strategy of air conditioning units based on load prediction and technologies such as fresh air cooling at night to ensure that environmental parameters are absolutely up to standard, and the annual air conditioning energy saving rate in the plant area has been achieved. The rate has increased by approximately 12%, achieving multiple goals of quality, compliance and efficiency.

From an international perspective, China pharmaceutical companies are accelerating their global layout, and their requirements for automatic control systems also need to be in line with international standards. Ruikongyuan's experience in successfully implementing pharmaceutical projects in Thailand proves its ability to serve multinational pharmaceutical companies and respond to international standards. For any pharmaceutical company that aims to develop in the long term, choosing an automatic control system partner that understands the particularities of the pharmaceutical industry, has experience in cross-regional compliance projects, and can provide technical support from design, verification to operation and maintenance is a key decision to ensure that the cornerstone of production is solid and win market competitiveness.