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Manufacturing system for injections

Two different buildings are used for manufacture of injections: one is dedicated to general injections and the other, to highly active injections. Manufacture of both ethical and veterinary drugs is feasible.
The pharmaceuticals building, our key plant completed in 1997, specializes in the manufacture of injections and liquids. In this building, the integrated production lines for vials and ampoules are installed, contributing to improved productivity and efficiency.
The injections building, dedicated to the manufacture of highly active drugs (e.g. anticancer agents and hormones), was completed in January 2003, in which integrated production lines for ampoules and batch-type production facilities for vials are in operation.

Performable contract manufacturing processes for injections

Annual manufacturing capacity

Pharmaceuticals building (General injections)
Vials: 15,000,000 vials (20 mL) - 3,450,000 vials (100 mL)
Ampoules: 15,000,000 ampoules (1 mL) - 9,000,000 ampoules (5 mL)

Injection building (Highly active injections)
Vials: 1,800,000 vials (10 mL) - 750,000 vials (100 mL)
Ampoules: 9,000,000 ampoules (1 mL) - 4,500,000 ampoules (5 mL)

Performable contract manufacturing items and limited items by workshop
  Antibiotics Hormones Anticancer agents
ƒΐ-lactam antibiotics Others Adrenocortical hormones Others LD50 <50 mg/kg
Pharmaceuticals building Manufacturing x x x x x
Packaging x ’ x ’ x
Injection manufacturing building (manufacturing) x ’ ’ ’ ’
Packaging building x › › › ›
Investigational products packaging building x x ’ › ›
Testing x › › › ›

›:contract manufacturing can be performed.
’:Evaluation of individual product items is required.
x :contract manufacturing cannot be performed.
Manufacturing: Includes primary packaging.@@Packaging: Indicates secondary packaging.

List of facilities for manufacturing general injections (Pharmaceuticals building)
Process Name of
facility or equipment
Manufacturer and model Performance and specifications
Integrated line for vials Washer BAUSCH FAU6000 10 mL:Φ32mm x 50mm
20 mL:Φ32mm x 58mm

50 mL widemouth
(mouth inner diameter: Φ22)
:Φ40.5 x 85mm

100 mL:Φ50.5-51.6mm x 100-94.5mm

100 mL widemouth
(mouth inner diameter: mouth Φ22):Φ50.5 x 102mm

4,000-1,100 vials/h

Dry heat sterilization tunnel BAUSCH DHT2580
Filler/stopper BAUSCH KSF1025
Seamer KT. MFG. Co., Ltd. 4E-CP
Visual inspection machine IDK Co., Ltd. IEBC-03
Stacking machine KT. MFG. Co., Ltd. TRY-100
Rubber stopper washing apparatus Kuraray Engineering Co., Ltd. NGW-25 17,000 pieces/batch;
Tub capacity: 100 L
Integrated line for ampoules Washer H.STRUNCK RURD07 1 mL(Φ10.2), 2 mL(Φ12.5),
3 mL(Φ14.4)C5 mL(Φ17.5)
5,000-8,000 ampoules/h
Dry heat sterilization tunnel H.STRUNCK TSQZ01
Filling and sealing machine H.STRUNCK AVRA04
Preparation of solution Solution tank for injectable solution for vials NGK Filtech, Ltd. 1,200 L x 2tanks with jacket: 85ºC, 4ºC
Solution tank for injectable solution for vials Shionogi Engineering Service Co., Ltd. 300 L with jacket: 85ºC, 4ºC
Solution tank for injectable solution for ampoules Daiwa Kakoki 150 L

Sterilization Autoclave Sanukida Seisakusho Co., Ltd. Inner volume: 2.760 m3
Autoclave Sanukida Seisakusho Co., Ltd. Inner volume: 2.944 m3, Shower sterilization also available
Inspection Automatic liquid inspection machine for vials Eisai Co., Ltd. AIM-1096 up to 1,800 vials/h
Eisai Co., Ltd. AIM-1088W up to 6000 vials/h
Automatic appearance inspection machine for vials Seidenader PI-10-B up to 6000 vials/h
Liquid inspection machine for vials Eisai Co., Ltd. AIM-1088W 6000 vials/h
Visual inspection apparatus Iwata Label Co., Ltd. 100 mL: 55 vials /min.,
50 mL: 60 vials /min.
Chidori stacking machine for vials Suzuki Machinery Co., Ltd. SA-1 For packaging unpacked vials
Liquid inspection machine for ampoules Eisai Co., Ltd. AIM-578SD up to 4,500 ampoules/h
Pinhole inspection machine for ampoules Nikka Densoku Ltd. HAD-II
Labeling and packaging Ampoule labeler Iwata Label Co., Ltd. up tp 6000 ampoules/h
Automatic tack labeler for vials Sansei Seiki Co., Ltd. up to 4,800 vials/h
Cartoning machine Mikita Machinery Co., Ltd. MKY-8G
Cardboard case packager O-M Ltd. VSB-85(VSBA-I)
Automatic tack labeler for vials Iwata Label Co., Ltd. CP-2064LASM up to 9,000 vials (5 vials per case x 1,800 cases)/h
Cartoning machine O-M Ltd. VSC
Cardboard case packager O-M Ltd. VSC
Shrink labeler Iwata Label CO., Ltd. CP-256/LASM 100 mL: 50 vials /min.,
50 mL: 100 vials /min.
Facility for producing water for manufacture MF unit NGK Filtech, Ltd. 5 m3/h
RO/CDI unit Trytech Co.,Ltd. (Veolia Water Solutions & Technologies) 3.2 m3/h
UF unit NGK Filtech, Ltd. 3 m3/h
PS unit NGF Filtech, Ltd. (STILMAS) 510 kg/h
WFI unit NGK Filtech, Ltd. (MAQUET GETINGE) 700 L/h
List of facilities for manufacture of injections requiring control (Injection manufacturing building)
Process Name of facility or equipment Manufacturer and model Performance and specifications
Vial production facilities Washer Kowa 10mL:Φ24.5 x 53mm
Dry heat sterilization apparatus Nitto Rika Kogyo Co., Ltd. DSP-5S 20mL:Φ32mm x 58mm
Filler/stopper Oogi Machinery Co., Ltd. PFG4-VG2 100 mL: Φ50.5-51.6 mm x 100-94.5 mm
Seamer BAUSCH KS1025 3000-11000 vials/h
Washer for outside of vials   30 mL and 10 mL: 30 vials/min.
Integrated line for ampoules Washer H.STRUNCK RURD07 1mL (Φ10.2), 2 mL (Φ12.5)
Dry heat sterilization tunnel H.STRUNCK TSQZ01 4 mL (Φ14.4), 5 mL (Φ14.4)
Filling and sealing machine H.STRUNCK AVRA04 5,000-8,000 ampoules/h
Weighing Safety cabinet (suitable for chemical hazards) Nippon Medical & Chemical Instruments Co., Ltd. VH-850S-C Biohazard protection level: Class II, Dust filter: HEPA filter
Negative pressure isolator Airex Co., Ltd. Exposure control level 4, Cleanliness class 100, Dust filter: Double HEPA filter, Carrying in and out: Pass box/Bag, Out port
Preparation of solution Solution tank for injectable solution Daiwa Kakoki 500 L with jacket: 85ºC
Solution tank for injectable solution Daiwa Kakoki 200 L with jacket: 85ºC
Sterilization Autoclave Nitto Rika Kogyo Co., Ltd. Inner volume: 2.328 m3
Facility for water for manufacture MF unit / ROEIon exchange system / Pure waterEdistilled water production system Organo Corporation PS: 250 kg/h / WFI: 250 L/h
Facilities for producing water for manufacturePreparation of solutionWashing and sterilization for vialsRubber stopper washingFilling,stopper insertion and sealing for vialsFilling and sealingFull automatic inspectionLabeling and packaging
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