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R&D and quality assurance systems Quality assurance system

With an aim at complying with the GMP that will be more sophisticated in the future, Nagase Medicals has established its quality management system supported by the quality assurance section responsible for QA functions and the quality control department responsible for QC functions.

ToxinometerClean bench for aseptic testsIncubator
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Technology development system

The technology development division is placed in the organization for manufacture and is responsible for transfer of contract manufacture-related activities. Under these circumstances, we will respond accurately and promptly to the needs of contract manufacture.
In the laboratory building that was completed in 2004, there exists a pilot plant section suitable for injections, liquids and ointments under a class 100 through to 100,000 air cleanliness level and the pilot plant section appropriate for solid preparations as well as health food products and cosmetics.
The laboratory building enables the above-stated pilot plant scale production and in addition, due to its structure of being connected to the quality control building (the testing section), provides a centralized and integrated system for investigation of possible formulations, pilot production through to analysis and evaluation.

Pilot production section IPilot production section IILiquid chromatography
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List of facilities and equipment in the laboratory building
Classification Equipment Manufacturer & model Capacity
Pilot production section I
Injections, liquids
(Class 100,000) (within the booth: Class 100)
Filling machine Fixed quantity filling machine Flexicon Corporation PF6 0.5-250 mL
Preparation tank Pressurized tank Advantech 20 L
Ampoule melt and sealing machine Desktop-type ampoule melt and sealing machine Fuji Glass Co., Ltd. 1-20 mL
Sterilizer High-pressure steam sterilizer Tomy Seiko Co., Ltd. 30 L
Pilot production section II
Granulation machine
Universal mixing stirring machine Dalton Co., Ltd. 3L (jacket) 0.3-1 kg/batch
High-speed mixer Fukae Kogyo Co., Ltd. 5L 1-5 kg/batch
Vertical-type cylinder extrusion granulation machine Fuji Electric Industry Co., Ltd. 5-10 kg/hr
Desktop-type spray drier Tokyo Rikakikai Co.,Ltd. Model SD-1 Solution feeding - 1400 mL/h
Grinder mill Rotor speed mill FRITSCH 50 g/batch
Power mill Showa Kagaku Kikai Kousakusho Co., Ltd. P-3 50-100 kg/h
Tableting machine Tableting machine Kikusui Seisakusho Ltd. RTS-9 5000 tables/h
Coating machine High coater Freund HCT-30N 0.7-1 kg/batch
Pilot production section III
Quasi-drugs, cosmetics
Emulsifier Agihomomixer Tokushukika Kogyo Co., Ltd. 1-2 kg/batch
Autohomomixer Tokushukika Kogyo Co., Ltd. 0.5-1.5 kg/batch
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