Company Profile
Founded in 2018 and located in Changzhou, Jiangsu Province, SRI (Jiangsu) Biological Equipment Co., Ltd. is a comprehensive solution provider focusing on complete isolation systems for the pharmaceutical industry. We provide customers with a full-chain integrated service including preliminary consultation, customized solutions, equipment R&D and manufacturing, installation and commissioning, technical training and system operation and maintenance.
We provide isolators and sealed protection systems in compliance with cGMP standards, engineered to the strictest standards in the global pharmaceutical industry.
We are more than just an equipment manufacturer. Our professional engineering team designs, validates and verifies each system to ensure full compliance with EU GMP, FDA 21 CFR and WHO GMP guidelines.
Adhering to independent innovation, the company focuses on pharmaceutical process safety and pollution control. Its core products, such as independently developed pharmaceutical negative pressure isolation equipment and sterile pharmaceutical filling isolation production lines, have been highly recognized by the market for their stable performance and compliance advantages.
The company's technical team is proficient in domestic and foreign pharmaceutical production regulations such as cGMP, FDA and NMPA, and is skilled in mastering the CSS (Contamination Control Strategy) throughout the product life cycle, forming core technical advantages in key areas such as internal environmental control of isolators, system integrity assurance, and production line process optimization.
The company has a modern production workshop of more than 30,000 square meters, which can meet diverse production needs from small-batch trial production to large-scale mass production. The workshop is equipped with automatic welding, intelligent assembly and online testing equipment to achieve standardized and efficient processes; meanwhile, it is equipped with an internationally compliant FAT test platform to support customers in simulated filling, leak testing, operation training and process validation.
The company fully implements GMP, ISO 9001 quality management system and ISO 14001 environmental management system. Through the Electronic Batch Record (EBR) system and central data management platform, it collects and stores production, testing and environmental data in real time, realizing digital traceability management of the whole process.
The company fully implements GMP, ISO 9001 quality management system and ISO 14001 environmental management system. Through the Electronic Batch Record (EBR) system and central data management platform, it collects and stores production, testing and environmental data in real time, realizing digital traceability management of the whole process.
Relying on complete hardware facilities, digital management capabilities and an experienced engineering team, Sairuiyi continues to provide customers with stable, reliable, compliant and efficient pharmaceutical equipment and system solutions. Our products and services have covered many well-known pharmaceutical and biotechnology enterprises at home and abroad.
