JPP-Ⅰ Juzen Pharmaceutical Plant -Ⅰ
A multi-purpose API plant that comprises with PIC/S GMP. From 2000 to 2019, JPP-Ⅰ 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-Ⅰ and Synthesis Facility
- A six-story plant with a total floor area of 4,656㎡, capable of manufacturing large-scale products of approx. 100-200 kg/batch.
- Design for the inside of the plant assures perfect cross contamination prevention with careful equipment configuration by adopting rational flow diagram, and air flow control system, as well.
- The 5㎥ autoclave and the ultra-low temperature reactor are installed, allowing for large-scale hydrogenation reactions and ultra-low temperature reactions.
- The continuous stirred tank reactor (CSTR) is installed, allowing for continuous flow reactions. We have a proven track record of safe preparation of highly exothermic Grignard reagent by suppressing heat generation through reagent feed flow rate control by using the CSTR (achieved production rate: 1M Grignard reagent approx. 60 L/h).
- JPP-Ⅰ is equipped with four Class 100,000 clean rooms.
Synthesis Zone
Central Monitoring Room
Clean Room Area
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-Ⅰ is equipped with Class 100,000 clean rooms where the following operations can be performed, enabling us to effectively meet the diverse customer needs.
- Sequence of crystallization, solid-liquid separation by the centrifuge, conical drying and packaging: 1 clean room
- Sequence of crystallization, solid-liquid separation and drying by the medium-sized filter dryer, and packaging: 1 clean room
- Solid-liquid separation and drying by large-scaled filter dryer/tray drying/conical drying, and packaging: 1 clean room
- Lyophilizing and packaging: 1 clean room
- Milling, such as jet mill, can be performed in some of these clean rooms.
Crystallization vessel
Filter dryer
Jet mill pulverizer
Facilities / Equipment
| Equipment type | Specifications | Number of units |
|---|---|---|
| Reaction vessel | GL0.5㎥-13㎥ | 21 |
| Reaction vessel | SUS0.5㎥-12㎥ | 16 |
| Autoclave | SUS5㎥、Hydrogen pressure＜1MPa | 1 |
| Ultra-low temperature reaction vessel/Autoclave | SUS5㎥、Hydrogen pressure＜1MPa | 1 |
| Centrifuge | SUS,HASTELLOY55B | 2 |
| Filter dryer | SUS,HASTELLOY1.50㎡-4.15㎡ | 6 |
| Vacuum tray dryer | SUS29L x 30trays / unit | 3 |
| Conical dryer | SUS,GL1㎥-2㎥ | 3 |
| Lyophilizer | SUSTrap condensate volume 300kg / unit |
2 |
| Vacuum vibration dryer | SUS0.6㎥ | 1 |
| Clean room | Class 100,000 | 4 |
| Milling equipment | Hammer mill (Atomizer), Pin mill (Kolloplex), Feather mill | |
| Ancillary equipment | Purified water generator (UFW), Nitrogen gas generator (PSA type) , Rotary distillation column（SUS,φ700×5600H, 8 plates） |
|
| Utility | Ultra-low temp. system: Cooling medium (Min-100℃) Steam, Cold water (10±5℃), Brine（-15℃ line, -30℃ line） |
|
| Continuous flow reaction system | Continuous stirred tank reactor (CSTR) SUS 135L（Feed flow rate max. 1.5L/min. or max.8L/min.） |
1 |
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)
