Collaboration with Hengrui Medicine, Assisting in the Construction of a GMP Clean Production System for Pharmaceuticals
#Service case ·2022-09-03 08:21:25
Hengrui Medicine, a leading listed biopharmaceutical company in China, focuses on R&D and production of antibody drugs and innovative medicines. Their requirements for the sterility, corrosion resistance, and cleanliness of fluid transfer equipment far exceed industry standards, strictly complying with GMP Class A cleanroom specifications and ASME BPE pharmaceutical standards. Having深耕 the field of pharmaceutical sanitary valves and fittings for many years, we developed targeted ultra-low carbon stainless steel aseptic diaphragm valves, quick-install check valves, and precision fittings. Our products feature surface roughness Ra ≤ 0.4μm, are non-permeable and leak-proof, resistant to strong acid/alkaline cleaning and high-temperature steam sterilization, fully meeting the core needs of aseptic transfer and precise flow control in pharmaceutical production. We provided a full-set customized fluid piping solution for Hengrui's bioreactors, purified water systems, and aseptic filling lines, offering comprehensive technical support from product design and manufacturing to on-site installation and commissioning, assisting the client in successfully passing the National Medical Products Administration (NMPA) GMP certification. Thanks to stable product quality and professional service, we established a deep cooperative relationship, becoming one of the valve and fitting suppliers for Hengrui's production bases, contributing to the high-quality development of China's high-end biopharmaceutical industry.