JPP-Ⅲ Juzen Pharmaceutical Plant - Ⅲ
A multipurpose plant with containment function. JPP-Ⅲ is structured to allow for exposure control according to the hazard levels of drug substances. This enables us to handle highly potent active pharmaceutical ingredients (HPAPIs), while minimizing the cross-contamination risk and workers health risk at a high level.
JPP-Ⅲ underwent an expansion (completed in August 2024) to establish a manufacturing area for oligonucleotides and introduce production equipment, as well as expanding the production lines for small-molecule APIs and intermediates.
Features of JPP-Ⅲ and Synthesis Facility
- A six-story plant with a total floor area of 9,444㎡, capable of GMP manufacturing of large-scale APIs approx. 170kg - 320kg/batch.
- To implement a highly effective cross-contamination prevention plan required for high-potency APIs, the production area is zoned into G Area (General) and C Area (Containment), with separate air conditioning systems, flow diagrams, and changing rooms.
- For ultra-low temperature reactions, 6000L reaction vessels and 8000L quenching vessels are installed, responding to commercial production.（G-Area）
- An inline mill（wet grinding mill）, which has a proven track record of being used for particle size control in commercial-scale crystallization processes, is equipped.
- A hydrogenation reaction vessel（GL, 3㎥）is equipped, enabling medium to large scale hydrogenation reactions using mixing blades capable of agitating even at low volumes.（G-Area）
- Hazard & Clean Area in the C-Area is equipped with 200L-1000L reaction vessels, filter dryer and jet mill, allowing for production of small volumes of APIs that require containment.
- The nucleic acid oligomer manufacturing area is equipped with solid-phase synthesis equipment (10-100mmol scale) and equipment for reaction (cleavage), chromatographic purification, membrane separation, evaporation concentration, and lyophilization. Purification and lyophilization are conducted within the Class 100,000 clean rooms.
Low temperature reaction vessel (6000L)
Quenching vessel（8000L）
Central Monitoring Room
Conical dryer
Centrifuge
G-Area
(Production area for Intermediates and general APIs)
- For production of APIs classified into the OEB (Occupational Exposure Band) levels 1 to 3, push-pull type ventilation system or local exhaust system is strategically adopted to prevent powder dispersion and defusal, thereby preventing cross-contamination and ensuring safety of workers.
- In the final manufacturing process of APIs, steps from crystallization and onward are performed within clean rooms in accordance with GMP. JPP-Ⅲ 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 (3㎥), solid-liquid separation by centrifuge, conical drying (2㎥), and packaging: 1 clean room
- For larger scale production, sequence of crystallization (6㎥), solid-liquid separation, conical drying (3㎥), and packaging: 1 clean room
- Milling operation, such as jet mill, can be performed in one of these clean rooms.
Synthesis Zone
(Push-pull type booth)
Synthesis Zone（Push-pull type booth）
Filter dryer
C-Area
(Production area for highly potent APIs)
- The 2nd floor and the 3rd to 6th floors of the JPP-Ⅲ are segregated as the C-Area, covering an area of 289 ㎡.
- Equipped with GMP-compliant equipment, capable of handling APIs at OEB levels 4 to 5, as well as intermediates with similar activity, and producing batch scales of approx. several kg to 50kg.
- According to the toxicity and powder properties of APIs, primary containment systems, such as soft isolators, rigid isolators, and containment transport containers, are utilized.
- In the area spanning from the 3rd to 6th floors, weighing, dispensing, reactions, crystallization, solid-liquid separation and drying of APIs and intermediates are conducted within the Class 100,000 Hazard & Clean Area. In this area, secondary containment system utilizing inter-room differential pressure control is adopted, ensuring both hazard management and a clean environment.
- On the 2nd floor, milling/packaging can be separately performed. The primary and secondary containment systems are similar system to those on the 3rd to 6th floors. Pulverizing by Jet mill or power mill can be carried out within the isolators.
Hazard & Clean Area
(crystallization vessel)
Hazard & Clean Area
(reaction vessel)
Hazard & Clean Area
(Isolator for weighing)
Hazard & Clean Area
(Filter dryer + Isolator)
Hazard & Clean Area
(Spiral jet mill built-in Isolator)
Hazard & Clean Area
(made by Micromacinazione Model: MC150)
G-Area Facilities and Equipment (Intermediates and General APIs)
Facilities / Equipment
| Equipment type | Specifications | Number of units |
|---|---|---|
| Reaction vessel | GL0.5㎥-8㎥ | 30 |
| Reaction vessel | SUS0.5㎥-6㎥ | 12 |
| Autoclave | GL3㎥ | 1 |
| Ultra-low temperature reaction vessel | SUS6㎥ | 1 |
| Centrifuge | ETFE48B | 5 |
| Horizontal centrifuge | HASTELLOYBaskeφ1.3m, Capacity 310L | 1 |
| Filter | SUS1.72㎡-3.14㎡ | 4 |
| Filter dryer | HASTELLOY2.54㎡ | 1 |
| Conical dryer | GL2㎥-3㎥ | 6 |
| In-line mill（wet mill） | SUSCircumferential velocity~23m/sec, Flow rate～20㎥/h |
1 |
| Batch recirculation reactor system (with a plug-flow reactor, PFR) | GLφ1m×H4m | 1 |
| Milling equipment | Jet mill (spiral type), SUS, 1.9N㎥/hr, Feather mill | |
| Sieving machine | Cartridge type vibration sieve | 1 |
| Clean room | Class 100,000 | 2 |
| Ancillary equipment | Purified water generator (UFW), Nitrogen gas generator (PSA type), Push-pull booth (OEB level 3), Distillation column (GL, φ350×2500H, 5 plates, Packing PFA cascade ring) |
|
| Utility | Ultra-low temp. system: Cooling media (Min -100℃), Heating media (-10～50℃), Cold water (10±5℃), Hot water (30℃-90℃), Brine (-15℃ line, -20℃ - -30℃ line) |
|
Small-scale production equipment (for highly potent APIs at OEB level 4-5)
Small Quantity Production Facilities
| Equipment type | Specifications | Number of Units |
|---|---|---|
| Reaction vessel | GL50L-1000L | 8 |
| Filter | GL0.19㎡ | 1 |
| Filter dryer | HASTELLOY（containing type）0.63㎡ | 1 |
| Milling equipment | Jet mill（spiral type, SUS, containing type） | 1 |
| Milling equipment | Feather mill（power mill, SUS, containing type） | 1 |
| Hazard & Clean Area | Class 100,000, OEB level 4-5 | 1 |
| Hazard & Clean Area (Milling Room) | Class 100,000, OEB level 4-5 | 1 |
| Utility | Steam, Cold water (10±5℃), Hot water (30-90℃), 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)
