GMP stands for "Good Manufacturing Practice for Drugs", which is used to strictly control the various operating units, personnel, environment, equipment and health aspects of drug production to ensure that the entire pharmaceutical process meets the health quality requirements. In the quality control system of pharmaceutical production, the air conditioning system of pharmaceutical factory is the key factor to create a clean and safe space environment. Therefore, strict compliance with GMP certification regulations, and the establishment of BMS system and EMS system for environmental monitoring is an important part of the pharmaceutical factory through GMP certification.
BMS plays a vital role in the GMP environment, and its control objects usually include the control of the cold and heat source of the air conditioning system, the air conditioning unit, the fresh air unit, the fan and so on, as well as the pressure difference control of the clean area and the room temperature and humidity control, and can carry out real-time monitoring and alarm. The precise control of BMS improves production efficiency, reduces operating costs, and provides reliable support for compliance and quality of production. In recent years, Wellthinic Technology has made many BMS systems in the pharmaceutical industry and accumulated rich implementation experience. In recent years, Wellthinic Technology has completed the commission and verification of a number of BMS systems in the pharmaceutical industry, and has accumulated rich implementation experience.
Project background:
In order to meet the production needs, Wellthinic technology has designed the corresponding control program and user interface in the automatic control system, so that each area of the room can be independently controlled. This ensures optimal temperature, humidity and environmental control in the production environment, providing customers with a more flexible, accurate and efficient production environment.
With the experience in the pharmaceutical industry, Wellthinic Technology provides customers with durable and reliable operation and maintenance services with professional technology and excellent service attitude. We are committed to providing customers with more perfect service, and establish a stable and long-term cooperative relationship with customers.
Service scope:
Air conditioning automatic control system protocol design, construction drawings design
Field controller and I/O module in automatic control system
Clean room temperature/humidity/pressure difference and other environmental sensors
Instrument sensors configured in various functional segments of air conditioning, weak current construction, and various installation auxiliary materials (including cables, Bridges, etc.)
Read third-party system data
System installation and commissioning, software design, engineering equipment drawings
System validation service
Project features:
Ensure that each independent air conditioning unit achieves high-precision temperature and humidity regulation through a consistent control algorithm to improve the uniformity and stability of the production environment.
In the event of abnormal events, the alarm is quickly provided, and intelligent control strategies are implemented to quickly adjust the operating status of the unit and minimize the impact on production.
Comprehensive data acquisition
The BMS system ensures the accuracy and integrity of the acquisition of key parameters, including temperature, humidity, pressure, etc., providing a more comprehensive understanding of the production environment and providing a reliable basis for data analysis.
Compliance with electronic records
The automatic control system meets the electronic records standards of US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures, including data security, signature authentication, etc., to ensure compliance with regulatory requirements and improve record credibility and compliance.
Our purpose:
Wellthinic Technology has always been customer-centric - from the aspects of hardware selection, temperature and humidity control, pressure difference control, etc., to complete the implementation of clean room BMS in pharmaceutical factories. With rich technical experience and professional team cooperation, we can design customized BMS solutions for each customer. Fully consider the actual needs of customers and implementation environment, to provide advanced, efficient and reliable BMS solutions and services. In the face of customer needs and problems, we are committed to actively and quickly respond to high quality design planning to help pharmaceutical companies upgrade industrial automation.
