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FACTORIES & EQUIPMENT

FUJIFILM Wako ChemicalHirono plant

  • LocationHirono-cho, Fukushima Prefecture
  • Site area139,000 m2
  • Number of employeesAbout 150
  • Start of operation1990
  • CertificationsISO9001 and ISO14001
外観写真
  • Category 5 high pharmacological activity ingredient manufacturing facilities
  • GMP compliant multipurpose facilities
  • Equipped with a super-low temperature reactor, a hydrogenation reduction reactor, a fluoride-resistant oven which are GMP compliant , and various mills.
  • Manufactures a wide range of pharmaceutical products incl. APIs, intermediates and high pharmacological activity ingredients.
  • Acquired a drug manufacturing license in 1997 and an FDA license in 2016.

Main facilities

  • Scale of the reactor:200 ~ 10,000L (GL, SUS, Teflon)
  • Reaction vessel:GL reactor, SUS reactor, Hydrogenation reduction reactor(SUS: ~0.5Mpa), Teflon reactor, Super low-temperature reactor(~-100℃)
  • Solid-liquid separation:Centrifuge filter, Filter dryer, High-speed decanter
  • Drying facilities:Biconical dryer, Vibration dryer
  • Special facilities:Dual-pipe concentrator, Multi-pipe concentrator, Various Granulation devices, Various mills

Manufacturing facility for highly potent APIs

  • Category 5 (OEL:0.1μg/m3
  • 600L and 800L reactor
  • Integrated manufacturing incl, micronization
Product API & early phase drugs cGMP non-sterile
Facilities Containment Area
・600 L(GL) Reactor x2
・800L Glass Lined Reactor
・Filter Dryer(0.38m2)×1
Material: Hastelloy ®C22 equivalent
・Micronization equipment: Spiral jet mill

General production area
600L(GL)x1
Multipurpose line
・Minimum mixing volume 50L
・Minimum mixing volume 50L
・Dryer filter capacity: 100L
Micronization equipment
・Made by Food and Pharma Systems

Analytical laboratory
management system isolated from production facilities)
Containment level Category 5 Down to OEL:0.1μg/m3
Cleanliness level ISO class 8 c lean room (Class 100,000 equivalent)
Temperature range ‒15~100 ℃ Reactor Jacket media: Brine
Building dimension ≒900m2 Approx. 900m2 2 fl oor s teel ACL concrete
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Large multipurpose API production facility

Ability to handle l arge scale production of API and intermediates

  • 10,000L l arge capacity reactor
  • API micronization capability (counter jet mill)
  • Crystallization reactor
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Scale 2,000~10,000L(GL/SUS)
QMS GMP
Special notes 6,000 L (SUS) low-temperature reactor (-30℃)
Counter jet mill
ISO class 8 c lean room

Clinical trial API manufacturing

Multi-line facility capable of a variety of reactions

Scale 1,000~2,000L(GL/SUS)
QMS GMP
Special notes 1,200 L ( SUS) low-pressure hydrogenation reactor (0.5 M Pa)
1,000 L (HC) super low-temperature reactor (-90℃)
2,000 L fl uoride resin lined reactor
ISO class 8 c lean room

API manufacturing

Capable of small-scale manufacturing

Scale 100~600L(GL/SUS)
QMS GMP
Special notes Column purifying device
ISO class 8 c lean room

API manufacturing (1st Plant)

20 years of experience manufacturing APIs

Scale 2,500~4,000L(GL/SUS)
QMS GMP
Special notes Final crystallization reactor: 2,500 L
Counter jet mill, hammer mill, and power mill
ISO class 8 clean room

Intermediate manufacturing (2nd Plant)

Cost reduction through large scale continuous production

Scale 6,000~10,000L(GL/SUS)
QMS GMP
Special notes 6,000 L (SUS) low pressure hydrogenation reactor (0.4 M Pa)
Handing n-BuLi