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The Technical Feasibility Analysis and Main Process Design of Drug-Eluting Stent Industrial Production
Author: ZhangXinBo
Tutor: ZuoHengChang
School: Shandong University
Course: Pharmaceutical Engineering
Keywords: Drug-eluting stents Industrialization Process design Shandong JW
CLC: TH789
Type: Master's thesis
Year: 2011
Downloads: 35
Quote: 0
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Abstract
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Represented by percutaneous transluminal coronary angioplasty and stenting, percutaneous coronary intervention technology in our country in recent years, the rapid development and application. Interventional medicine works is through the use of a range of interventional devices and materials (or called minimally invasive devices and materials) and modern digital diagnostic equipment, diagnostic and treatment operations. Compared with traditional surgery with less trauma, less bleeding, shorter operative time, rapid postoperative recovery, etc., which greatly reduce patient surgery pain, reduce the risk of surgery, it is possible within a very short time to save the patient's life. But later than in other countries due to the development of the domestic interventional devices and the lack of professional and technical personnel, resulting in the the the clinical interventional devices for domestic use imported products, and even some of the varieties of equipment on all imported products, and increase the burden of the patient's medical, resulting in the waste of medical expenses, and not consistent with the state and central guiding spirit of building a harmonious society. The interventional device localization voices growing drug-eluting stents as representatives of the interventional device, its localization and industrial production attracted national attention, and the strong support of the national industrial policy Shandong JW Medical Products Co. The company's biodegradable industrial production of drug-eluting stents It is in this context. Shandong JW Medical Products Co., Ltd. of drug-eluting stents industrial production in the original production process and reference to international advanced production equipment for processing metal stents, the production of conveyor system, drug coating on the stent, coated stent pre- installation and product sterilization process optimization and validation, to expand the scale of the original production, to achieve the level of industrial production. Contains a series of production process due to the production of drug-eluting stents, only two new process is described, electrochemical polishing and automatic coating of the stent, using orthogonal test method to determine the appropriate process parameters. Results: Drug-eluting stents annual production capacity of 200,000 sets, metal bracket to reach an annual output of 200,000, the delivery system to reach an annual output of 200,000. Product registration standards of product quality and performance in line with the level of the rate of qualified products more than 90%, and reached the advanced level, the annual output value of 600 million yuan.
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CLC: > Industrial Technology > Machinery and Instrument Industry > Instruments, meters > Medical and health devices > Other medical devices
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