HOME >> 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.
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)
| Antibiotics | Hormones | Anticancer agents | ||||
| ΐ-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.
| 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 |
| 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 / ROEIon exchange system / Pure waterEdistilled water production system | Organo Corporation | PS: 250 kg/h / WFI: 250 L/h |
