The Technical Feasibility Analysis And Main Process Design Of Drug-Eluting Stent Industrial Production

Interventional technology in PTCA and stent implanted is fast developed and popularly applied in China in recent. Interventional engineering is the diagnosis and operation in clinical combined a series of interventional medical devices and materials and digital diagnosis equipments. Compared with the traditional treatment method, interventional technology has more advantages including minimally invasive, less blood, short of surgery time and health recovering rapidly after operation, so it reduces the suffer of patients and the risk of the operation and saves the life in shortly time. But the development of interventional medical devices in China is far behind of some other developed country and more interventional medical devices are obtained by importing, this condition cause the treatment cost increasing and is not complied with the requirement of harmonious society. So promoting the localization process of interventional medical devices especial drug eluting stent is more important in China and this industry is supported by the station policy. The biodegradable coating drug eluting stent industrialization of JWMS is just under this background.This study is realized by optimization and qualification of bare stent process, delivery system process, drug coating process, stent pre-mounted process and sterilization process basis on the older manufacturing process and introducing the advanced equipments.A series of processes are in the drug eluting stent manufacturing, so only two new processes are described in this study, such as metal stent polishing process and auto-coating process. These two processes are designed and validated by orthogonal experimental design to obtain the optimized process parameters values.Result:the production capability of drug eluting stent is 200,000 suits, the production capability of bare stent is 200,000 pieces and the production capability of delivery system is 200,000 pieces. The product quality and performance are complied with the deign specification, the level of conformance of product is more than 90%, and achieved the international advanced level and this project annual production value will be 6 billons Yuan.