Our Misato Factory has obtained GMP certification from overseas authorities such as FDA, ANVISA, and Russia, and the manufactured pharmaceuticals are supplied to more than 50 countries by our customers. Various automated facilities enable us to manufacture solid dosage forms and injectable dosage forms on a large scale. At the Misato Cold Chain Center, we can also provide contract inspection, packaging, and storage of biopharmaceuticals and regenerative medicine products under low temperature control.
The site area is approximately 173,000 square meters, which includes the space for the Plant area where pharma are manufactured, as well as separate space for welfare facilities (gymnasium, playing field, etc.). The total floor space of the plant is approximately 57,000 square meters, consisting of a solid dosage production building, an injectables building, a warehouse building and a QC area. Our Misato plant features a wide range of large scaled manufacturing equipment, allowing our solid dosage manufacturing capacity to be approximately twice that of the Kawagoe facility.
The Misato factory is GMP certified not only in Japan, the United States and Europe, but has also acquired GMP certifications from many countries including South-East Asia, Central and South America, the Middle East and Africa. With these degrees of certification, this factory manufactures commercial products for almost all countries on all five continents. As with the Kawagoe Plant, the Misato Plant is capable of quality testing that meets the JP, USP and EP pharmacopeias.
Manufacturing Building 1 and the N1 Workroom
(solid dosage manufacturing and packaging area)
The solid dosage manufacturing area contains Manufacturing Building 1 and the N1 Workroom for the manufacture and packaging of sugar-coated tablets, film-coated tablets and plain tablets. All the manufacturing buildings are equipped with dedicated air conditioning and with differential air pressure maintained between manufacturing rooms and corridors to prevent contamination, and ongoing environment support management. The manufacturing area is also managed to maintain a cleanliness class of 100,000, a room temperature of between 17 to 28℃ and humidity of between 30 and 65%RH. The tableting machines and coating machines operate mainly at nighttime for production efficiency. The packaging area is divided into the filling area for primally packaging and the packaging area for secondly packaging. Different air pressures make Cross-contamination prevention and hygiene maintained.
Manufacturing Building 2 (injectables manufacturing and packaging area)
The injectables manufacturing and packaging area comprises Manufacturing Building 2. It has the capacity for everything from the manufacture of ampule, vial, pre-filled syringe and freeze-dried pharmaceuticals manufacture to packaging. Humidity, temperature and pressure differences, air speed and hygiene grade are intensively controlled in the manufacturing room and monitored using a round-the-clock monitoring system. In addition, for sensitive injectables to light, light blocking functionality is also in place in the manufacturing room. The manufacturing area has an integrated system for the preparation of liquid pharmaceuticals, filling and sterilization (except for aseptic packaging). There are three sterile ampule lines for filling 1-3 ml, 5-10 ml and 1 ml ampules respectively, one vial line, one pre-filled syringe line and one freeze-dried pharmaceuticals line. All packaging takes place in the packaging area, which has four lines for ampule, one line for vial, one line for pre-filled syringe and one line for freeze-dried pharmaceuticals. The storage of semi-finished products takes place in an automated, air-conditioned warehouse. From there, the products are automatically dispatched for processing.
J Center (Warehouse)
The J Center is a manufacturing support facility where raw materials, packaging materials, and products are brought into and dispatched from. Inside the J Center are large-scale racks with the capacity to store 3,860 pallets. Some of these automated racks are ordinarily air-conditioned and others are specially air-conditioned. Products, raw materials and excipients requiring air-conditioning are stored in the specially air-conditioned racks and maintained. The operating management system and automatic transport system in the warehouse are computer controlled. Transport within the warehouse is by a completely automated unmanned system. There is also a refrigerated warehouse A storage space is also set aside for hazardous substances.