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文章出处:Enterprise|阅读量:704|发表时间:2020-07-23
Warmly celebrate the successful signing of the "Shanghai Maijike Medical Mask Production Project and New Laboratory Project" with Shanghai Jixin. Shanghai Maijike Project Management Co., Ltd. is a R&D and production-oriented enterprise focusing on the production of masks, meltblown cloth, and anti-epidemic technology products.
The following is the signing information of CEIDI Xidi and Shanghai Jixin Refrigeration Equipment Engineering Co., Ltd.:
Medical mask production workshop and testing laboratory
I. Project overview:
Project Name: Shanghai Maijike Medical Mask Production Project and New Laboratory Project
Project location: 5th Floor, Building 7, No. 166, Mindong Road, Caolu Town, Pudong New District, Shanghai
Project content: Medical mask production workshop project, new testing laboratory project
II. Introduction to medical masks and testing laboratories:
Medical mask production workshop: medical masks (medical protective masks, medical surgical masks, disposable medical masks) all belong to the second category of medical equipment. For the mass production of medical masks, corresponding design and development must be carried out, samples must be produced under GMP conditions, and product technical requirements must be compiled in accordance with the "Medical Device Registration Management Measures", submitted for registration inspection, preparation of registration materials, and product registration. Since it is in the clinical exemption catalog, there is no need for clinical trials, but clinical evaluation is required, and a comparison description between the declared product and the similar products already on the market is submitted. The comparison statement should include the working principle, product material, structure composition, main technical performance indicators, disinfection/sterilization methods, intended use, whether it is used in the home, etc.
Testing laboratory: The testing laboratory mainly has these partitions: acceptance and storage area for samples submitted for inspection; acceptance and storage area for reagents and standard products; cleaning and washing area; special operation area; general analysis and experiment area; data processing and data storage District; office; personnel room such as dressing room or lounge. The main functional rooms are: central laboratory; instrument room; microbiological examination room; drying room; quality inspection office, archives room and other management functions.