JPP-Ⅱ Juzen Pharmaceutical Plant -Ⅱ
A multipurpose APIs and intermediates plant that complies with PIC/S GMP. From 2005 to 2019, JPP-Ⅱ received multiple FDA GMP inspections and was highly evaluated for the high level of GMP control. We have established a manufacturing management system that complies with global standards, enabling us to effectively meet the needs of our international customers.
Features of JPP-Ⅱ and Synthesis Facility
- A six-story plant with a total floor area of 2,749㎡, capable of manufacturing a wide range of scales from tens of kg to 330kg/batch.
- In the synthesis zone, to ensure cross-contamination prevention, such measures as installing charge-in booths and segregating centrifuge room and dryer rooms are taken.
- As well equipped, this plant can accommodate diverse reaction conditions, thus suitable not only for commercial production but also for production of investigational drug substances on a scale of several tens of kilograms or more.
- Sufficient utility equipment enables us to perform a wide range of reactions. Cooling/heating media from -15℃ to 300℃ are available with the chiller/heating units.
- JPP-Ⅱ is equipped with two Class 100,000 clean rooms.
- JPP-Ⅱ is outfitted with a distillation column. Mixed solvents and hydrous solvents discharged from the manufacturing process are distilled by the column for separation and reuse (for other industrial use). Our manufacturing is designed with careful attention to reducing the energy load associated with waste disposal.
Synthesis Zone
Synthesis Zone
Dryer Room
Synthesis Zone
Purified water production system that combines reverse osmosis (RO) and ultrafiltration (UF) membranes
Clean Room
In the final manufacturing process of APIs, steps from crystallization and onward are performed within clean rooms in accordance with GMP. JPP-Ⅱ is equipped with Class 100,000 clean rooms, where the following operations can be performed, enabling us to effectively meet the diverse needs of our customers.
- Sequence of crystallization, solid-liquid separation by centrifuge, vibration drying, and packaging in acid-resistant CR: 1 clean room
- Solid-liquid separation by filter dryer, vibration drying, and packaging in alkaline-resistant CR: 1 clean room
- Milling operation, such as jet mill, can be performed in one of these clean rooms.
Clean Room Area
Inside Clean Room
（Centrifuge, Vibration dryer）
Inside Clean Room
（Filter dryer, Vibration dryer）
Facilities / Equipment
| Equipment type | Specifications | Number of units |
|---|---|---|
| Reaction vessel | GL0.6㎥-10㎥ | 16 |
| Reaction vessel | SUS0.6㎥-6㎥ | 11 |
| Centrifuge | ETFE48B | 4 |
| Mobile centrifuge | HASTELLOY20B | 1 |
| Filter dryer | SUS2.50㎡ | 1 |
| Vacuum vibration dryer | HASTELLOY1.6㎥ | 1 |
| Vacuum vibration dryer | SUS1.6㎥ | 1 |
| Conical dryer | GL1㎥-2㎥ | 3 |
| Nauta dryer | SUS2㎥ | 1 |
| Clean room | Class 100,000 | 2 |
| Milling equipment | Hammer mill（sample mill, pulverizer）, Feather mill（Pharma mill） | |
| Ancillary equipment | Purified water system（UFW）, Distillation column （SUS, φ400×2000H, MC pack 8 plates） | |
| Utility | Steam, Hot water（30℃-90℃）, Heating medium（max. 300℃）, Cold water（10±5℃）, Brine（-15℃） | |
Inquiries
Please feel free to contact us even for small-scale production or small projects
Inquiries by Phone
[Available Hours] 8:30 – 17:00 on
weekdays (excluding Sat. Sun. and national holidays)
