HOME >> R&D and quality assurance systems
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.
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.
| 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 | ||