Design And Implementation For E-beam Sterilization Project Of W Medical Devices Enterprise

For the past few years, with the growth of the global population and development of economic, the needs for medical devices in every country are growing. In this environment, medical devices market is growing rapidly with great market space. Disposable sterilized medical devices take a great proportion in medical devices market. They need to be sterilized strictly before being used. The most common sterilization method is ethylene oxide sterilization in domestic. This method brings lots of problems because of its own defects in the aspects of sterilization result, process quality control, and environmental protection, etc.In the homogenization market competition background of medical devices, in purpose of increasing competitiveness and additional value of products, W medical devices enterprise takes a lead in introducing new sterilization technology to provide treatments for the medical devices of its own.As the main participant of the E-beam sterilization project for medical device, the writer researches the background and significance of the project, surrounding the status and development trend of the medical equipment industry; Analysis the necessity of the project, combining with the developed countries the situation of the medical instrument sterilization; Analysis the superiority, weakness, opportunity and threaten of the project and puts forward countermeasures;On the design and implementation of the project aspects, firstly define the design requirements of project important influencing factors by Quality Function Deployment tool. The general design covers hardware design of equipment and workshop, and the software design of sterilization validation and quality management system; Carry out the project according to the design, finish workshop construction, equipment installation and tuning on time by using schedule management tool; finally, basing on workshop and equipment meeting requirements, establish guarantee mechanisms according to the enterprise actual status; execute sterilization validation and optimize the process in the trial production stage, complying regulations and standards requirements of medical device industry, and make sure medical device E-beam sterilization project to be put into production successfully.During the project carrying out, scientific project management theories and medical device industry special requirements direct the design and implementation of the project effectively, and make sure the enterprise become to be the first medical device enterprise which uses E-beam sterilization.