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          2. Quality

            Technical Equipment

            Microbiology lab equipped with independent air purification systems .Detection equipment including dust particles counter, and key collection sex plus or minus pressure test instrument, and biochemical training box, and two gas phase color spectrum instrument, and mold training box, and air cover, and micro-pressure poor meter, and purification table, and biological security cabinet, and analysis balance, and pull machine, and temperature humidity meter, and wind speed instrument, and vernier caliper, and acidity meter, and conductivity rate instrument, all by statutory measurement or by correction .Daily products, clean environment, process water, made accurate monitoring of gas technology.

            Production Standards

            Company according to the GB/T19001, YY/T0287, medical device manufacturing practices and MDD has established a quality management system, covering the disposable sterile syringes with needles, disposable dispensing syringes, sterile, disposable insulin syringes。Current version is the c version, introduced on August 15, 2014。

            Production Environment

            Hangzhou LongDe medical products  limited company  has 100,000 class clean workshop of 8500 square meters, the laboratory area of 800 square meters.Equipped with standard physics lab, chemistry lab, microbiology lab, microbiology lab has a positive test, microbiological laboratory, aseptic room .Sterile room, microbiology lab for thousands under the background of Baiji laminar flow work station, positive for thousands of biological safety cabinets in the background.

            Purification environment and quality system assurance

            The  existing program documentation including quality manual, procedures and management systems, operating instructions, equipment operation, design drawings, specifications product specifications, inspection standards and the external file containing the national or regional regulations.

            Our company has over more than 20 quality personnel to participate in TUVISO13485:2003;MDD93/42/EEC, Wah kwong GB/T19001-2008idtISO9001:2008, YY/T0287-2003idtISO13485-2003, wit ISO9001:2008;ISO14001:2004, system training, obtain the appropriate internal audit qualifications, fan running, to ensure strict quality guarantee system.

            At present, the company has made ISO9001:2008, ISO13485:2012 and YY/T0287:2003 standards-compliant quality system assessment certificates.


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