JPP-Ⅲ(JUZEN PHARMACEUTICAL PLANT-Ⅲ) Multi-purpose plant to cope width HPAPI
JPP-Ⅲ is a multi-purpose plant responding to containment, completed in July, 2015.
This plant is so structured as to be able to achieve exposure control depending upon the hazard level of the drug substance, and to cope with Highly Potent API while reducing the cross contamination risk and health risk of operators at high level.
Featuers of JPP-Ⅲ
- Steel-framed 6 tories (31.5m x 34m x 31.7m) of expandable plant dedicated to API
- Utility balcony facilitating the future extension of air conditioning equipment is adopted.
- In order to realize the high level of cross contamination prevention plan required by Highly Potent API, production area is segregated into G-Area (general) and C-Area (containment), along with separate systems of air conditioning, flow diagram, and changing clothes.
- For low temperature reaction, 6000 L of reaction vessel and 8000 L of quenching vessel are installed, enabling the response to the request of commercial production.
- In the Hazard & Clean area inside the C-area, 200 - 1000 L of reactors, a Filter dryer and a jet mill are accommodated to respond to small amount of production of API requiring containment.
G-Area(Area for the production of intermediate and general API)
Responding to category 1 through 3 (OEL: over 10 µg/M3 ) of API production
Push-pull ventilation device or local exhaust etc. is appropriately adopted, enabling the prevention of scattering or spread of powder which is intended to carefully prevent cross contamination and ensure safety of operator.
C-Area(Area for the production of Highly Potent API)
Such pilot scale to commercial production scale of equipment are installed as able to respond to the handling of API of category 4 or higher(OEL: 1 - 10 µg/M3 )
Responding to the toxicity and powder characteristics of the handled API, Primary containment system is adopted including soft isolator, rigid isolator or containment carrying vessel etc.
Regarding the operational area, Hazard Area to implement reaction process etc. and class 100,000 of Hazard & Clean Area to handle final product being segregated, Secondary containment system is implemented by accommodating both respective controls of hazard and cleanliness through room pressure control.
- ・Hazard & Clean Area
(Reactor)
- ・Hazard & Clean Area(Isolator for weighing)
- ・Hazard & Clean Area(Filter dryer + Isolator)
- ・Hazard & Clean Area(Milling room)
(Spiral Jet Mill built-in Isolator)
- ・Spiral Jet Mill
(Model MC150, produced by Micromacinazione)
Facility and equipment in the plant(JPP-Ⅲ) in compliance with GMP
| Description of equipment | Specification | numbers |
|---|---|---|
| Reaction vessel | GL 0.5M3 -8M3 |
11 |
| Reaction vessel | SUS 0.5M3 -6M3 |
10 |
| Low temp reaction vessel | SUS 6M3 |
1 |
| Centrifuge | ETFE 48B |
4 |
| Filter | SUS 3.14M2 |
1 |
| SUS 1.72M2 -2.29M2 |
2 | |
| Filter dryer | SUS 3.14M2 |
1 |
| Conical dryer | GL 2M3 -3M3 |
2 |
| Hazard & Clean room | class 100,000 | 1 |
| Hazard room | 1 | |
| Ultra-low temp facility | Cooling medium (min -100℃),Heating medium (-10℃-50℃) | |
| Utility | Steam, Cold water, -40℃ of brine | |
| Kinds of facility / equipment | Specification | numbers |
|---|---|---|
| Reactor | GL 0.05M3 -1M3 |
9 |
| Reactor | SUS 0.2M3 |
2 |
| Filter | GL 0.2M2 |
1 |
| Filter dryer | Hastelloy(containment specification) 0.63M2 |
1 |
| Mill | Spiral Jet Mill(containment specification) | 1 |
| Hazard & Clean Room 2 (for small amount production) |
class 100,000 | 1 |
| Hazard & Clean Room (Milling room) |
class 100,000 | 1 |
| Utility | Steam, cold water, -40℃ of brine | |
(Crystallization vessel)