Sairui Yi has a clean factory with an area of 2500 square meters, equipped with a constant temperature and humidity control system, real-time environmental monitoring and alarm system, to ensure that the entire production process is controllable and traceable. The factory layout is scientific, with independent production areas for soft isolators, raw material and finished product buffer zones, and advanced blown film machines, fully automatic bag making machines, and STAR slitting machines in China. It can complete the research and development and large-scale production of soft isolators under strictly controlled conditions, and produce products that meet domestic and international standards. At the same time, there is a dedicated FAT testing area in the factory, which can provide full functional factory acceptance testing for hard isolators, meeting various needs from small batch trial production to large-scale production.
In the production process, Sairuiyi introduces automated welding, assembly, and online testing equipment to achieve standardization and efficiency of the production process, reducing human errors. Equipped with a FAT testing platform that meets international standards, it supports customers in simulating filling, leak testing, operational training, and process validation to ensure comprehensive quality assessment is completed before delivery.
In terms of quality management, the company fully implements GMP and ISO 9001 quality system and ISO 14001 environmental management system certification, combined with electronic batch records (EBR) and a central data management platform, to collect and store production, testing, and environmental data in real time, achieving full process traceability.
With this complete set of hardware facilities, digital management capabilities, and experienced engineering and technical team, Sairuiyi can not only ensure the stable quality and compliant delivery of isolator products, but also assist customers in shortening project cycles, reducing verification and operational costs, and promoting more efficient and safe aseptic production.