naniwa
NANIWA RUBBRER CO.,LTD.
Zip Code: 635-8520
2-6-1 Soone Yamato‚”akada-City Nara-Pref. JAPAN
TEL:+81-745-52-5681
FAX:+81-745-23-1998
NANIWA RUBBER CO.,LTD
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Feature
The young and highly qualified staff members of our R&D division have courage to try for new ideas and perseverance to overcome difficulties. They are always searching for the latest domestic and overseas information and are striving for improvement of the quality of our products through direct contact with end-users.
R & D of rubber and plastic products for pharmaceutical use combines polymer technology with medical technology. To work in these fields, we have various kinds of laboratory instruments such as chemical analyzers and measuring machines, and we also keep live animals for biological tests . In addition to controlling quality to meet the specifications of both domestic and foreign standards, we also are studying the effect of closures on the medicines by analyzing the extracting substances and vaporized substances as well as by checking gas permeability in order to ensure long.term storage life of medicines. Our closures have easy handling characteristies and therefore can support the effici. ency of the pharmaceutical manufacturers operation.
On the other hand, our rubber nipples, whic'h are indispensable for the healthy growth of babies, meet the specification of the standards of BGA(Germany) and FDA(U.S.A.) which regulate the nitrosoamine and other extractable substances .
As medical plastic devices, we are producing Artifical kidney blood tubing set , Plasma pheresis blood tubing set and clinical check circuits together with the development of plastics for new meclical products.
One of our success. ful products, for example, is a DOP.free soft PVC composition, called Medidex.
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Most of the machines in our plant are designed by our own engineering, supported by a long experience in production technology. The machines are designed for high productivity, for easy of control and of cleaning, and for prevention of malfunction in case of operator error. The machines are also designed to be interchangeably used for production of either large or small lots in accordance with the varying requirments of our customers.
Cleaning of closure is done by an automatic washing machine which combines high temperature extraction, pyrogen breakdown and high pressure water washing. Each lot of closures is evenly washed by the circulation of the chemical solution in the machine, which is controlled by the computer. The treatment conditions such as composition of chemical solution, temperature and time are computerized. Washing water is filtered by a UF membrane. Fungi, pyrogens and micro particles in the water are removed by this filter.
Closures are directly dried by hot air passed through HEPA filters. The drying machine has been designed to be highly effective in reducing the moisture content of the closures by using an all-fresh-air system.
During the cleaning and drying stage, the closures are transported by carrying basket, lot by lot. We have two lines for washing and drying. On one line,250 kgs of closures ih one basket are washed and dried, while on the other line, four different 5Okgs lots of closures, each in a separate basket, can also be washed and dried at one time.
The hot and dry closures are then rapidly cooled in the clean system by chilled, low-moisture and dust-free air. Last operations, such as final inspection and packaging, are carried out in a controlled clean room.
The Production line of medical plastic instruments begin with the processing of raw materials in various kinds of shaping machines such as extruder, blow molder, t-die molder, injection molder etc.
High-freguency welding, assembling, inspection, sterilization and packaging are done in a continuous process on clean line, which has been specially designed for medical plastics production. Sterilization equipment provide two systems of steam and ethylene oxide gas. Especially Sterilization equipment is automatically controlled by computers and is constantly maintained at the best sterilizing conditions.
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Production is controlled by a list of internal standard check points, based on the GMP Record on operation, machine environment, etc. documents the quality of the product in parallel with the test records at each stage of production.
Our rubber closures is registered in DMF of FDA, while rubber closures and medical plastic products approved by ISO9001. The quality of our medical plastic products meet to the specifications of the standards publicly announced by the Japanese Ministry of Health, as Well as specifications set up by the Pharmaceutical Plastic Products Association, which also require the checking of fungi, bacilli and pyrogen for each lot.
‚h‚r‚n9001-2008
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