Production Division
Manufacturing Facilities for API and Pharmaceutical Intermediates
As well as the pharmaceutical intermediate manufacturing facility completed in 2000, we have a multi-purpose manufacturing facility for pharmaceutical intermediates that was added in 2006. It can handle many kinds of processes using flexible hoses, and is installed with many reaction tanks, the biggest of which are on a scale of 8,000 liters, centrifuges, desiccators, and various other equipment.
It is also installed with a Class 100,000 clean room, and its equipment includes reaction tanks of various sizes, including a 5,000-liter one, centrifuges and desiccators. A cleanroom with ISO 8 (Class 100,000) acid-resistant material came into operation in July 2018. The facilities naturally conform with cGMP, and due attention is also paid to the environment and health and safety. They offer an integrated production system for everything from pharmaceutical intermediates to APIs.
Pharmaceutical Intermediate Manufacturing Equipment (Multi-Purpose Manufacturing Equipment)
API Manufacturing Equipment (Cleanroom: ISO 8)
Overview of the Equipment
| Intermediate/crude crystal | API (Cleanroom: ISO 8) |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Line 1 | Line 2 | ||||||||
| Jacketed mixing tank (reaction tank) | GL | 3,000 - 4,000L | 2 | GL | 1,500L | 1 | GL | 3,000L | 1 |
| 5,000L | 2 | 7,000L | 1 | 5,000L | 2 | ||||
| 8,000 - 10,000L | 3 | 8,000L | 1 | ||||||
| SUS304 | 3,000 - 4,000L | 3 | SUS304 | 6,000L | 1 | ||||
| SUS316L | 5,000 - 8,000L | 2 | SUS316L | 6,000L | 1 | ||||
| Centrifuge | TFL | 48B | 2 | TFL | 36B | 2 | TFL | 36B | 2 |
| SUS316L | 36B | 1 | |||||||
| Dryer | Conical-type | Conical-type | Pan dryer | ||||||
| NSGL | 3,000L | 1 | NSGL | 3,000L | 1 | SUS316L | 2,100L | 1 | |
| Biaxial stirring dryer | |||||||||
| SUS304 | 3,000L | 1 | |||||||
| Other | Oxygen concentration meter Water for manufacturing purposes, only for the manufacturing buildings (deionized water & UF water) |
||||||||
Investigational New Drug API and Pharmaceutical Intermediate Manufacturing Facilities
The Iwate Plant has several API production lines in operation, and is is equipped with two production lines that conform to the GMP for API and investigational new drugs.
Line 1 is a production line made up of equipment that mainly consists of GL tanks or varying sizes between 100 and 500 liters. It is comprised of manufacturing equipment that is based upon the assumption that it will produce new investigational drugs on a scale of between 10 and 50 kilograms, and handle the process from the reaction to crystallization, separation, and dessication, as well as a product chamber where ISO 8 dust-proofing measures are in force.
Line 2 is a production line composed of equipment with a maximum of between 1 and 1.5 tons. It manufactures APIs on a scale of between 50 and 100 kilograms in an integrated process from the reaction to crystallization, separation, and desiccation. It has an ISO 8 product chamber.
List of Line 1 Equipment
| Type | Material | Size | No. | |
|---|---|---|---|---|
| Reaction tank/Crystallization tank | SUS304 SUS316L GL, NSGL |
500L 500L 100 - 500L |
1 1 7 |
|
| High-pressure reaction tank | SUS304 SUS304 |
800L 100 - 500L |
1 2 |
Press 780Kpa |
| High-vacuum distillation towers | Glass | 200L | 1 | |
| Centrifuge | TFL TFL |
30B 24B |
1 1 |
|
| Dryer | NSGL TFL |
300L 65L |
1 1 |
Conical-type Vibration dryer |
List of Line 2 Equipment
| Type | Material | Size | No. | |
|---|---|---|---|---|
| Reaction tank/Crystallization tank | GL GL GL SUS316L |
500L 1,000L 1,500L 800L |
1 1 1 1 |
|
| Centrifuge | SUS304 PFA/SS400 |
30B 30B |
1 1 |
|
| Carbon filter | HC22/SS400 | 0.5m2 | 1 | |
| Dryer | PFA/SUS304 | 240L | 1 | Vibration dryer |
Cleanroom Annex
| Item | Main equipment | Material | Size | Number of equipment |
|---|---|---|---|---|
| General area | Reaction tank | Conductive GL | 3,000L | 1 |
| Cleanroom | Crystallization tank | Conductive GL | 3,000L | 1 |
| Centrifuge | Conductive TFL | 36B | 1 | |
| Conical dryer | Conductive GL | 2,000L | 1 | |
| Manufactured product | APIs, investigational new drugs | |||
| Building size | 3-storey steel frame building with a total floor space of 1,230 m2 | |||
About the Iwate Plant
A green parkland plant in harmony with the natural environment
The Iwate Plant manufactures various types of product groups. It is located in Hachimantai, Iwate Prefecture roughly 600 km from Tokyo and around 40 km north-west of Morioka. It has views of Mount Iwate to the south and the mountains of the Towada-Hachimantai National Park to the west. It is blessed with an environment that has pure water and great natural beauty throughout the changing seasons.
The Iwate Plant has roughly 450,000 m2 of land. Stage 1 of its construction was completed in 1978, and the plant came into operation in 1979. Since the completion of Stage 2 in 1981 and Stage 3 in 1985, the Iwate Plant has operated as our Pharmaceuticals & Fine Chemicals Business production base. Stages 4 and 5 of its construction were carried out in 2000, setting up a production system for pharmaceutical intermediate related items, with an emphasis on optically active substances.
In addition, the Iwate Plant has in place the cGMP control system required for the manufacture of pharmaceuticals. We have several items registered with the American FDA, and have undergone a number of inspections since 1984 in which we have received high ratings.
We are moving forward steadily with environmental measures. Following the agreement on environmental pollution control concluded with Hachimantai (Matsuo-mura), Iwate Prefecture in 1977, our anaerobic treatment facility was completed in 1992. The aim is to be an environmentally-friendly plant, and we acquired ISO14001 certification in the spring of 2001.
