Pharmaceutical Production Unit

This webpage introduces our main factories that manufacture and package formulation products.

Pharmaceutical Production Unit

Pharmaceutical Production Process

Area separation

Area separation

The pharmaceutical production area is entered through a door different from the door to the packaging area. These areas are controlled separately according to different standards.
In each locker room, workers change into the cleanroom clothing specified for the area.

Entering the workroom

Entering the workroom

After changing clothes, workers wash their hands not to bring foreign matters into the work area. (upper left)
With a sticky roller, workers remove foreign matter from the entire surface of their cleanroom clothing. (upper right)
Then, also with a suction cleaner, they remove foreign matter from the surface of their cleanroom clothing, especially where parts of the clothing overlap, for example, around the neck. Then, they put on gloves. (lower left)
Finally, with an air shower, they remove foreign matter from the surface of their cleanroom clothing. Air blows out to knock down any foreign matter, which are carried away by exhaust. (lower right)

Weighing (MES) <!-- -->

Weighing (MES)

In the weighing process, workers weigh out the amounts of raw materials necessary for manufacturing a formulation product for each production unit.
When a raw material arrives from a logistics warehouse, a worker scans the QR code on the label of the raw material according to the instructions of the manufacturing execution system (MES) and weighs out a specified amount of the raw material with a weighing scale. If there is no problem with the weighing, a label will be printed out. The worker affixes the label to the bag containing the weighed raw material. This systematized process prevents human errors, including mix-ups between raw materials.

Blender

Blender

The raw materials weighed in the weighing process are evenly blended in a blender so that each tablet, when formed, contains the same amounts of pharmaceutical ingredients. Daito uses Bohle (the one in the picture) and V-shaped blenders. The charge amount of each blender is between 5 and 700 kg.

Fluid-bed granulator and dryer

Fluid-bed granulator and dryer

For some products, powdered raw materials are shaped into granules prior to the blending process. This granulation process enhances content uniformity and processability. For granulation, we use a fluid-bed granulator and dryer (the one in the picture) and a high shear granulator.

In the granulation process, a binding liquid is sprayed onto the powdered raw material placed in the granulation equipment to form granules. This piece of equipment is automatically controlled. Once a worker sets manufacturing conditions, it automatically operates to manufacture products.

Tableting

Tableting

In the tableting process, the powder or granules blended in the blending process are pressed and shaped by a tablet press into tablets. Tablet presses automatically weigh the tablets produced and automatically sift out out-of-specification tablets. Daito has various types of tablet presses to cover low- to high-volume production. The production capacity of each tablet press is 30,000 to 430,000 tablets per hour.

Film-coating

Film-coating

For some products, the tablets shaped in the tableting process are film-coated. Film-coating is a process of coating tablets with water-soluble high molecular weight substances. Film-coating has the effects of masking bitterness to make the tablets easier to take and of making them less subject to light and moisture.
Daito has various types of film coaters to cover low- to high-volume production. The charge amount of each film coater is between 5 and 500 kg.

This equipment is automatically controlled. Once a worker sets manufacturing conditions, it automatically performs film-coating.

Tablet laser printing device

Tablet laser printing device

In the tablet printing process, the product name and amount of components are printed on the surface of each tablet with a laser or inkjet printing device. Printing the product name and other information has the effect of preventing patients on our medications from taking the wrong drug by confusing it for the right one.
A camera is installed inside each printing device. Tablets with a printing defect are automatically detected and sifted out.

Automated tablet inspection machine

Automated tablet inspection machine

In the inspection process, the appearance of tablets is inspected, and those with defects, including cracks and contamination with foreign matter, are screened out. The automated tablet inspection machine is automatically controlled. Once a worker sets inspection conditions, it automatically operates to inspect tablets. The automated tablet inspection machine is suitable for inspecting products that are produced in large quantities at one time. We strive for quality enhancement by examining the defects of tablets that are screened out and giving feedback to the preceding manufacturing process.

Visual inspection

Visual inspection

Tablets are, as a rule, inspected by the automated visual inspection machine, but some products are visually inspected by inspectors. Visual inspection is mainly suitable for inspecting products that are produced only in small quantities at one time and tablets that are special in shape or size, such as small ones. Inspectors periodically undergo a test on screening out defective products, and only the inspectors who have passed the test conduct the visual inspection.

Blister packaging

Blister packaging

The tablets that have passed the visual inspection are packaged. Daito employs packaging called “blister”* for many of its products.
* Blister sheets, a type of drug packaging, hold tablets and capsules sealed individually between a plastic sheet and aluminum foil.
Pushing a plastic blister hard breaks the aluminum backing behind it to take the tablet/capsule out of the blister, while the other tablets/capsules are kept sealed. (left)
Workers check the packaged products so that there are no abnormalities in the appearance. (right)

Check by more than one worker

Check by more than one worker

When setting manufacturing conditions of a machine, two workers check them to prevent setting errors.
The workers in this picture are checking the settings of a fluid-bed granulator and dryer.

Packaging Process

Entering the workroom

Entering the workroom

The packaging area is controlled according to standards different from those for the pharmaceutical production area, so workers are dressed differently.
However, the same procedure for thoroughly removing foreign matter applies to workers entering the packaging area: hand washing and the use of a sticky roller, a suction cleaner, and an air shower.

Banding <!-- -->

Banding

After tablets are packaged in units of 10 with blister sheets in the pharmaceutical production area, the sheets are bundled up with film in units to be put in consumer boxes (10 sheets in this picture) and then transported to the cartoning process. Before this next process, every single bundle is inspected with a weight checker to confirm that it contains the correct number of tablets.

Cartoning

Cartoning

The blister sheets, bundled up in the previous banding process, are packed in consumer boxes, and the boxes are sealed with glue.

Laser printing on the consumer boxes

Laser printing on the consumer boxes

On each consumer box (sales and packaging unit), a barcode containing the following information is printed: (1) serial number, (2) expiration date, and (3) product code given to that particular sales and packaging unit.
While the consumer boxes are being conveyed at high speed, they are irradiated with a laser to print the above information on them.

Packing in outer boxes (corrugated cartons)

Packing in outer boxes (corrugated cartons)

In this production line, robots pack consumer boxes into outer boxes.
The robots bundle up a certain number of consumer boxes, set up outer boxes (corrugated cartons), put each bundle in an outer box, and seal the outer boxes with tape. The robots also affix a management label to each of the outer boxes.

Palletizing <!-- -->

Palletizing

The robots stack the sealed corrugated cartons on a pallet in a predetermined pattern.

Transportation <!-- -->

Transportation

Once the required number of outer boxes are stacked on a pallet in a predetermined pattern, a worker draws up the pallet with the boxes on it and carries them to a warehouse.

Keeping batch records

Keeping batch records

In the packaging area, the production volume, the number of defective products, and the number of labeling and packaging materials used are counted carefully, and workers keep and manage these records in real time to prevent any use of wrong labeling or packaging materials or any shipment of products in an improper packaging condition.

Other Manufacturing Aids

Packaging area control room

Packaging area control room

This is a control room of the packaging area. Control work in the room supports daily production operation.

Low insect-luring illumination

Low insect-luring illumination

The entrance of the factory is equipped with special lighting that does not easily attract insects.

Exterior of Formulation Buildings

Fifth Formulation Building

Fifth Formulation Building

This formulation product factory building, completed in 2001, houses the No. 3 Logistics Center.
As of 2021, this factory building has the largest floor area (about 10,000 m2) at Daito.

The Sixth Formulation Building

The Sixth Formulation Building

This formulation product factory was built adjacent to the No. 5 Formulation Building in 2008 and houses the No. 6 Logistics Center.
This six-story factory is the tallest of all our factories. It has the second largest floor area (about 9,000 m2) behind the the Fifth Formulation Building.

Connecting corridors

Connecting corridors

All major formulation buildings are linked by connecting corridors, which enables the easy coming and going of raw materials, products, and personnel between the buildings.

Other Related Facility

Cubicle <!-- -->

Cubicle

This high-voltage substation supplies power to each of our formulation product factories and API factories.