High Potent Compound Products
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High Potent Compound Products Unit
During the manufacture of high potent compound products, we ensure the containment of highly active materials.
Manufacture
Weighing with a glove box
In the weighing process, we use a glove box for the containment of highly active materials. A raw material is put in the glove box through the input port dedicated for raw materials. A raw material is weighed inside the glove box.
Putting the weighed material in an IBC*
The weighed raw material is put directly in an IBC* attached under the glove box. An IBC is later simply called a "container."
* IBC: Intermediate bulk container
Container lift
The container holding the raw material is transported upward by a container lift so that the container can be attached to the raw material input port on top of a granulator.
Attaching the container to a granulator
The container holding the raw material is attached to a granulator. Since the raw material is charged directly into the granulator from the container, there is no risk of scattering highly active materials, and worker safety is ensured.
Fluid-bed granulator and dryer
This piece of equipment is automatically controlled. Once a worker sets manufacturing conditions, it automatically operates to manufacture products.
Transporting a container and taking granules out of it
Finished granules are put in a container and transported to a workroom for the next process.
Film-coating
After tableting, the tablets are film-coated. This equipment is automatically controlled. Once a worker sets manufacturing conditions, it automatically performs film-coating.
Measures against environmental pollution
Our air intake and exhaust system is equipped with high-performance filters to prevent an outflow of highly active materials to the outside. The wastewater that contains highly active materials from the High Potent Compound Product Building is stored in dedicated tanks, collected by a specialty contractor, and incinerated.
Exterior of Buildings
The Seventh Formulation Building
In this formulation building completed in December 2014, we manufacture medium-scale (15 to 30 kg/lot) high potent compound products.
The Eighth Formulation Building
In this formulation building completed in November 2018, we manufacture large-scale (50 to 100 kg/lot) high potent compound products. At the time of its completion, this building had only one production line. In December 2020, the second production line was completed, doubling the production capacity.
Quality Control
Glove box for weighing
When sampling a highly active material (API), workers are wearing chemical protective clothing and weigh the material inside a glove box because powder can easily scatter.
Powder containment enclosure
When handling a highly active material still in powder form for a laboratory test, workers use a powder containment enclosure (as seen in the picture).
The powder containment enclosure is designed to flow air from the outside into the inside, preventing the powder inside the enclosure from escaping.
The highly active materials sucked up from the device are collected and then disposed of or incinerated according to the prescribed procedure.
Dissolution test of highly active materials (formulation products)
The worker in this picture is testing the dissolution of a highly active material (formulation product).
Once dissolved in liquid, highly active materials pose a low risk of scattering. So, they can be handled by workers wearing simple protective clothing.
Microbial test of highly active materials
This test checks for the presence, type, and number of bacteria and fungi contained in highly active materials (APIs and formulation products).
While conducting this test, workers are wearing chemical protective clothing to protect themselves from the highly active materials.
Building
High-potent Drug R&D Center
This facility was newly established in 2017 to conduct research, development, and testing of highly potent compounds.
The 1st and 3rd floors are testing rooms, and on the 2nd floor there are rooms for API laboratory and for prototyping and small-scale production of formulations.
The second floor is also capable to manufacture investigational drug (formulation).