API Production
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API Production Unit
The API Production Unit manufactures APIs, or active pharmaceutical ingredients of drug (formulation) products. The quality of APIs is greatly related to the safety and effectiveness of the pharmaceutical products that contain the APIs. We manufacture high-quality, high-value-added APIs while taking full control of them.
Workers wear gloves, goggles, and gas masks for organic solvents and take safety precautions, including local exhaust ventilation, static electricity grounding, and nitrogen injection.
API Production
Reaction vessel pointing and calling
Personnel perform pointing and calling to confirm safety and what they are working on. Safety confirmation is especially essential because they use volatile organic solvents and powdered raw materials (which float in the air).
Reaction vessels varied in capacity (for chemical reaction and crystallization)
Raw materials that meet test standards are placed in reaction vessels and blended to cause chemical reaction and synthesize the mixture into objective substances. Temperature, time, and other conditions are strictly controlled.
After the chemical reaction is complete, the material is cooled to crystallize (precipitate as crystals).
Centrifuge bowl
The inner part of a centrifuge bowl spins like the tub of a washing machine, separating the substances that have completed chemical reaction into the objective substances (solid) and solvent (liquid). The worker in this picture is connecting a reaction vessel upstairs to the centrifuge bowl with a hose. (He is not wearing gloves because he is only preparing for the process.)
Changing into protective clothing
In the drying process and beyond, the work area is dusty.
To ensure safety, workers change into protective clothing, as well as put on gas masks for organic solvents, goggles, and gloves.
Conical dryer
From the wet crystals separated with the centrifuge bowl, organic solvent is volatilized, and the crystals are dried.
Decompression, heating, and rotation volatilize and suck up the organic solvent, which is then liquefied with a cooling device and recovered to prevent it from flowing out to the external environment.
API Packaging
Entering the API packaging building
To work in the clean area, workers wash their hands and put on a mask, a hairnet, and protective clothing so as not to bring foreign matter or dirt into the workroom.
Charging materials into a mill
We have various mills to meet customers’ different needs for different particle size.
The particle size of APIs is a significant factor because it affects the dissolution of the formulation products manufactured from the APIs.
(Jet mills, pin mills, pulverizers, and other mills)
API Packaging Building Hallway
Each workroom is designed not to let air flow out to the corridor so that an API in a workroom is not contaminated by the dust of a different API from another workroom.
Status display boards
We use status display boards so that you can see at a glance what is going on in each workroom.
Temporary storage
Manufactured products are temporarily kept in storage in the factory.
They are well maintained under required air conditioning conditions.
API packaging building office
The staff at the office monitor the temperature and work progress on the work floors and prepare documents necessary for manufacturing.
Exterior of API-related Buildings
Fifth API Building
This building, completed in 2007, has the largest floor area of all our API factories as of 2022.
Many tanks and pipes for many types of organic solvents are arranged on the wall of this building.
Sixth API Building
This is an API factory building completed in November 2015.
This factory building is designed to be easily operable and suitable for high-mix low-volume production.
With the “one room, one machine” design, which enables simultaneous production of many different products while preventing contamination by foreign matter, this factory achieves excellent safety, high quality, and enhanced productivity. Moreover, a gravity system, which utilizes gravity drop, enhances this factory’s economic efficiency.
No. 3 API Packaging Building
This is one of our factories that package APIs.
The building was completed in November 2015 along with the Sixth API Building.
Other API factories
These relatively small-sized API factories were built in between the 1980s and 2010.
(The First API Building, the Second API Building, the Third API Building, the First API Packaging Building, and the Second API Packaging Building)
Other Related Facility
Wastewater treatment facility
Wastewater is a byproduct of our production activities. At this wastewater treatment facility, organic substances in the wastewater are decomposed until they fall below the level at which the wastewater may be released to the environment. Then, the treated wastewater is discharged into the sewage system.
Waste oil collection by tank truck
Organic solvents used in the manufacture of APIs are disposed of by a specialized disposal contractor to ensure no impact on the environment.