Production Division

Equipments of manufactuirng API and Intermediates.

New plant for producing pharmaceutical intermediates

Our plant for manufacturing intermediates with two independent production lines, designed for 1 equipment /1 room, was completed in 2023. We will achieve a 25% increase in production capacity, and will strongly promote the expansion of development pipeline and the expansion of new contracts.

Item Main equipment Material Size Number of equipment
General Area Reaction tank Conductive GL,SUS 6,000~8,000L 9
Centrifuge Conductive TFL 48B 4
Conical dryer Conductive GL 3,000L 2
Manufactured product Pharmaceutical intermediates
Building size Four-storey steel frame , Floor area 2,150m2

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
Appearance
reaction tank
dryer