高风险医用聚烯烃树脂洁净化生产技术开发及工业应用

Development of pure production technology and industrial application of high-risk medical polyolefin resin

针对高风险医用聚烯烃树脂亟需解决的超纯净化生产工艺、可迁移物控制、安全性评价等问题,中国石油开发出超纯净医用聚烯烃树脂成套技术,解决了聚烯烃树脂中可迁移催化剂残留、低聚物及助剂含量高等难题;首创了符合药品生产质量管理规范的医用聚烯烃树脂质量管理体系,实现了医用聚丙烯树脂和聚乙烯树脂的规模化生产,建成了我国首套200 kt/a超纯净医用聚烯烃树脂生产基地,突破了制约我国医用聚烯烃树脂产业链发展的瓶颈。

In view of the urgent problems of the ultra-pure purification production process,migratory catalyst control,and safety evaluation of high-risk medical polyolefin resin,a set of ultra-pure medical polyolefin resin technology was developed to solve the problems of high amount of migratory catalyst residues,oligomers,and additives in polyolefin resin.The first medical polyolefin resin quality management system in line with drug production quality management standards was developed,and the large-scale production of medical polypropylene resin and polyethylene resin was realized.China’sfirst 200 kt/a ultra-pure medical polyolefin resin production base was built,breaking through the bottleneck restricting the development of China’s medical polyolefin resin industry chain.