Our Kawagoe Factory has GMP certifications in more than 20 countries, including FDA, ANVISA, Health Canada, and the EU (VMD). We provide manufacturing services and packaging of clinical trial and pharmaceutical products from small-scale to large-scale, and we inspect and package products that require low temperature control such as biopharmaceuticals, vaccine, and regenerative medicine. At the Medical Device Center we also inspect and package medical devices and combination products.*
* Combination Products that combine medical devices and pharmaceuticals (including biological products)
The Kawagoe facility has acquired GMP certifications for Japan, the United States, Europe and Canada, and is fully compliant with the GMP requirements of other countries. The facility undergoes GMP audits by about 20 different companies each year and engages in ongoing measures to further enhance its output quality. Kawagoe has the capability to carry out tests that are JP-, USP- and EP-compliant and maintains the latest voluntary data management system, as LIMS. Kawagoe provides consistent quality control support, from the development of test methods through to stability testing.
Concept and Layout
Plant Concept and Layout
Our plant was constructed in 1981 by Sandoz Yakuhin, the forerunner of the present Novartis Pharma, designed and supervised based on a European concept. Branching off from a roughly 180 m long central corridor are interconnected buildings for manufacturing, packaging, warehousing, engineering/maintenance, and QC testing. We also have a separate Medical Device Center. The plant site covers around 65,000 m2, with a total floor area of around 38,000 m2, and offers plenty of scope for future expansion.
All our manufacturing buildings use pressure difference management to prevent contamination from the manufacturing rooms to the clean corridor, with positive air pressure on the clean corridor side and negative pressure on the manufacturing room side. In addition, we maintain the manufacturing areas at a cleanliness class of 100,000, with the room temperature held at between 18 to 28°C and humidity levels of between 40 and 60%. The No. 2 Manufacturing Building has a vertical flow system (vertical transport), and we are working on increasing efficiency by using automation and automatic transport systems so that we can even operate at night.
This is divided into an area for primary and secondary packaging for solid pharmaceuticals and an area for secondary packaging for injectables. The primary packaging area is maintained at a cleanliness class of 100,000, with the room temperature held at between 18 to 28°C and humidity levels of between 40 and 60%. The secondary packaging area is has a room temperature held at between 18 to 28°C. All packaging lines in the secondary packaging area are divided by partitions in order to prevent contamination and create a proper working environment.
We have two major warehouses. The first is a large automated high-rise warehouse, and the other is a refrigerated warehouse. The automated high-rise warehouse is managed using an AGV (automated guided vehicle) system and computers, as we work to automate the distribution system to the warehouse, the central corridor, and the various manufacturing buildings. The refrigerated warehouse has its own backup power supply to cope with any unexpected power outages. We also have a special storage area for hazardous substances.