CDMO Business CDMO Specifications

Highly Potent Pharmaceutical Products

注射剤(液剤)|ガラスバイアル

Injectable (liquid formulation) | Glass vial

Occupational exposure limits (OEL)
> 0.15 μg/㎥
Liquid preparation scale
5–200 L
Filling volume
0.5–80 mL
Filling capacity
Max 4,500 vials/hr
注射剤(液剤)|樹脂バイアル

Injectable (liquid formulation) | Resin vial

Occupational exposure limits (OEL)
> 0.15 μg/㎥
Liquid preparation scale
5–200 L
Filling volume
0.5–50 mL
Filling capacity
Max 4,000 vials/hr
注射剤(凍結乾燥)|ガラスバイアル

Injectable (lyophilized powder) | Glass vial

Occupational exposure limits (OEL)
> 0.15 μg/㎥
Liquid preparation scale
5–200 L
Filling volume
1–80 mL
Filling capacity
Max 4,500 vials/hr

Traditional Pharmaceutical Products

注射剤(液剤)|ガラスバイアル

Injectable (liquid formulation) | Glass vial

Occupational exposure limits (OEL)
> 100 μg/㎥
Liquid preparation scale
150–1,200 L
Filling volume
10–100 mL
Filling capacity
1,000–4,000 vials/hr
Inspection capacity: (Visual inspection)
up to 6,000 vials/hr
注射剤(液剤)|ガラスアンプル

Injectable (liquid formulation) | Glass ampoule

Occupational exposure limits (OEL)
> 100 μg/㎥
Liquid preparation scale
50–150 L
Filling volume
1–5 mL
Filling capacity
5,000–8,000 ampoules/hr
Inspection capacity: (Visual inspection)
up to 4,500 ampoules/hr
液剤|ボトル

Liquid formulation | Bottle

Manufacturing environment (classification)
- Liquid preparation
Class 100,000
- Filling
Class 100,000
Liquid preparation scale
100–2,000 L
Filling capacity
up to 2,400 bottles/hr
Inspection capacity: (Visual inspection)
(Visual testing)
ゼリー剤|チューブ

Jelly formulation | Tube

Manufacturing environment (classification)
- Liquid preparation
Class 100,000
- Filling
Class 100
Liquid preparation scale
250–2,000 L
Filling capacity
up to 9,600 tubes/hr
Inspection capacity: (Visual inspection)
up to 10,000 tubes/hr

Medical Devices

注射剤(液剤)|ガラスバイアル

Injectable (liquid formulation) | Glass vial

Occupational exposure limits (OEL)
> 0.15 μg/㎥
Liquid preparation scale
5–200 L
Filling volume
0.5–80 mL
Filling capacity
Max 4,500 vials/hr
注射剤(液剤)|樹脂バイアル

Injectable (liquid formulation) | Resin vial

Occupational exposure limits (OEL)
> 0.15 μg/㎥
Liquid preparation scale
5–200 L
Filling volume
0.5–50 mL
Filling capacity
Max 4,000 vials/hr
注射剤(凍結乾燥)|ガラスバイアル

Injectable (lyophilized powder) | Glass vial

Occupational exposure limits (OEL)
> 0.15 μg/㎥
Liquid preparation scale
5–200 L
Filling volume
1–80 mL
Filling capacity
Max 4,500 vials/hr
注射剤(液剤)|ガラスバイアル

Injectable (liquid formulation) | Glass vial

Occupational exposure limits (OEL)
> 100 μg/㎥
Liquid preparation scale
150–1,200 L
Filling volume
10–100 mL
Filling capacity
1,000–4,000 vials/hr/dd>
Inspection capacity: (Visual inspection)
up to 6,000 vials/hr
注射剤(液剤)|ガラスアンプル

Injectable (liquid formulation) | Glass vial

Occupational exposure limits (OEL)
> 100 μg/㎥
Liquid preparation scale
50–150 L
Filling volume
1–5 mL
Filling capacity
5,000–8,000 ampoules /hr
Inspection capacity: (Visual inspection)
up to 4,500 ampoules/hr
液剤|ボトル

Liquid formulation | Bottle

Manufacturing environment (classification)
- Liquid preparation
Class 100,000
- Filling
Class 100,000
Liquid preparation scale
100–2,000 L
Filling capacity
up to 2,400 bottles/hr
Inspection capacity: (Visual inspection)
(Visual testing)
ゼリー剤|チューブ

Jelly formulation | Tube

Manufacturing environment (classification)
- Liquid preparation
Class 100,000
- Filling
Class 100
Liquid preparation scale
250–2,000 L
Filling capacity
up to 9,600 tubes/hr
Inspection capacity: (Visual inspection)
up to 10,000 tubes/hr

Drug Delivery System
(DDS)

We can manufacture investigational drugs including liposomes, micelles and lipid nanoparticles (LNP). Please contact us using the form below for details of our DDS specifications.