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GMP compliant manufacturing facility

Hirono plant has the multipurpose manufacturing facility for highly potent APIs which is compliant with category 5 and able to perform integrated manufacturing incl. micronization.


Appearance of 3rd plant



Equipment specifications

API & early phase drugs


cGMP non-sterile

Facilities Containment Area
 600 L(GL) Reactor x2
 800L Glass Lined Reactor
 Filter Dryer (0.38m2)
 Material: Hastelloy C22 equivalent
 Micronization equipment: Spiral jet mill
Multipurpose line
 Minimum mixing volume 50L
 Minimum mixing volume 50L
 Dryer filter capacity: 100L
Micronization equipment
 Made by Food and Pharma Systems
General production area
Analytical laboratory
management system isolated
from production facilities
Containment level Category 5 Down to OEL: 0.1μg/m3
Cleanliness level ISO class 8 c l ean room
(Class 100,000 equivalent)
Temperature range -15~100℃ Reactor Jacket media: Brine
Building dimension Approx. 900m2
2 floor s teel ACL concrete

Milling and crushing of APIs

Various types of mills and crushers are available to meet API manufacturing requirements.

Counter jet mill ・Particle diameter 5 μm or less

Hammer mill ・Particle diameter 5 μm to 50 μm

Power mill ・Various types of screens are available.
・Round hole screen: 2 mm, 3 mm, and 5 mm
・Herringbone screen: 2 mm

Highly versatile spiral jet mill

  • Milling particle diameter: 1 μm to 30 μm
  • Production quantity: up to 30 kg/hr. 100 g to 100 kg/batch
  • Simple structure that allows for easy cleaning Cleaning is possible in the isolator.
  • Large particle sizes (up to 100 μm) are also possible. e.g. Q-MILL: up to 100 μm
  • Can be expanded to handle milling at an extremely low temperature (-90°C)
  • Prior testing of the milling capability can be performed(200 mg/batch)


Particle diameters can be controlled by adjusting the feed pressure, milling pressure, and feed amount.

※ Cited from FPS milling machine catalog of CORRENS CORPORATION


Custom manufacturing facilities for pharmaceutical products

Various kinds of facilities and equipment can cover a wide range of scale.
We propose the process with the optimal facility according to the stage from development to commercial production.




Special notes

Pilot production manufacturing Capable of Scale-up checking (Hiratsuka plant)
40~100L (GL) nonGMP Kilo lab facility
600~1,500L (GL) nonGMP 600L fluoride resin lined reactor
API, Clinical trial API manufacturing Capable of small-scale manufacturing (Miyazaki plant)
GMP ISO class 8 clean room
Clinical trial API manufacturing Multi-line facility capable of a variety of reactions (Hirono plant)
GMP 1200L(SUS) low-pressure hydrogenation reactor (0.5MPa)
1,000 L (HC) super low-temperature reactor (-90℃)
2,000 L fluoride resin lined reactor
ISO class 8 clean room
API manufacturing Capable of small-scale manufacturing (Hirono plant)
GMP Column purifying device
ISO class 8 clean room
API manufacturing(1st plant) 20 years of experience manufacturing APIs (Hirono plant)
GMP Various mills
(Counter jet mill, hammer mill and power mill)
ISO class 8 clean room
Intermediate manufacturing(2nd plant) Cost reduction through large scale continuous production (Hirono plant)
GMP 6,000L(SUS) low-pressure hydrogenation reactor (0.4MPa)
Handling n -BuLi
Highly potent API manufacturing(3rd plant) Category 5 high pharmacological active ingredient manufacturing facility (Hirono plant)
600~800L (GL) GMP Filter dryer (0.38m2)
Spiral jet mill
ISO class 8 clean room
API manufacturing(4th plant) Large multipurpose APIs production facility since 2017 (Hirono plant)
GMP 6,000L(SUS) low-temperature reactor (-30℃)L
Counter jet millL
ISO class 8 clean room