Hangzhou Singclean Medical Products Co., Ltd., established in March 2003 with registered capital of 80, 000, 000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials. With well-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices and drug injection products of Class III that confirm to the laws and regulations of the State Food and Drug Administration (SFDA) and EU MDD.
The company set up a joint research center with Zhejiang University of Science and Technology, and has well established R & D cooperation relations with Zhejiang University, Donghua University and Zhejiang University of Technology, developing four series of new products with proprietary intellectual property rights, and with a variety of high-tech products to be developed cooperatively. The company also built an R & D platform for medical biomaterials that keeps up with the international level, and made major breakthrough in many key technologies such as those for stopping bleeding, anti-adhesion, and tissue engineering basic materials, with more than 10 patents obtained and a number of products applying for the patents.
The company's plant in Xiasha covers an area of 13, 000 m² With the construction area of 17, 000 m² And producing tract of 13, 200 m² Including cleanrooms of 2, 300 m² In which cleanroom of Class C covers 2, 000 m² And that of Class B covers 300 m² With over 60 m² Of which follows into Class A. A new cleanroom up to GMP standard was set up in this plant, and the Pharmaceutical Production License was obtained in 2012. It will produce all kinds of medical equipment and medical 10 million sets, production value 2 billion, In addition, the plant has introduced more production facilities such as the Invoa filling machine from Germany, the sterilizer from GETINGE, the semi-automatic filling and sealing equipment from Pluemat, 5T / h purified water machine, 3T / h water for injection machine, and1T / h of pure steam generator.
Respect for life strict quality control
The company has set up a documentation-based GB/T19001-2008, YY/T0287-2003, Good manufacturing Practice for medical devices, Good manufacturing practice for In vitro diagnostic reagents, good manufacturing practice of drug, 2010, medical device directive (MDD93/42/EEC ), according to quality objectives, auit resullt, data analysis, corrective and preventive actions and management review, in order to maitain the continued suitability and effectivenss of the quality managenment system.
Cohesion of technological strength improving core competitiveness
The company has been always laid stress on product rsearch and development, investing annually 10% of the sales to comstruction of R&D center, new product development and introduction of advance equipments. The R&Dcenter is equipped with cleanroom in Class 10000(including Class 100) of more than 200m² , and it has acquired a number of patent technologies.
Committing herself to develop new types of composite and smart biomaterials, the company majors in producing biodegradable bio-materials and their derivatives, and has at present products of 7 series (chitosan, medical sodium hyaluronate gels, cross-linked hyaluronic acidsodium gels, microporous polysaccharide, oxidized regenerated cellulose, basic materials of tissue engineering, in vitro diagnostic reagents), 50 varieties, being sold in 30 provinces and cities across the country, with users totaled more than 1, 000. Moreover, some of the products are exported to over 20 countries around the world, such as Italy, Russia, Indonesia, Turkey, Australia, and France.