There are normally 3 steps by which the Pharma, Chemical and other industries bring the products into existence – lab trials, process development and manufacturing.
The process development is the link between the lab and plant. To accomplish this scale up the process engineering group must have the know-how of both lab experiments and the plant scale ups. 2 primary deliverables from the process development are production of API and or generation of process knowledge. To accomplish this the tools available with the process engineering group are Kilo labs and Pilot Plants.
Sl.no
Kilo Labs
Pilot Plants
1
It’s a first scale up effort to produce enough quantities for initial drug testing or sample testing.
Pilot Plants are larger than Kilo labs with designs more close to production plants.
2
Kilo labs are more closer to lab equipment.
Pilot plants are more closer to commercial manufacturing plants in design and capacity.
3
Designed to yield quantities ranging from 100 g to under 10 kg of material with a typical batch size of 2~3 kgs.
Designed to demonstrate potential commercial routes and generation of process knowledge through data collection.
4
Kilo Lab Reactor size is usually ranging from 20 litres to 100 litres and are made of glass( smaller size hence glass is feasible).
Pilot Plant reactor size typically ranges from 200 L to 4000 L.
5
Kilo lab must be designed for higher degree of flexibility to accommodate a range of complex chemistries.
Pilot Plant must also operate with a degree of flexibility and absorb process and schedule uncertainty.
3
Operating staff is chemists or chemical engineers.
In Pilot Plant the roles are similar to a commercial manufacturing plant.
Product Specifications
Capacity ( Litres) (Kilo Scale)
10 to 250
Capacity (KL) (Pilot Scale)
Upto 2 KL
Temperature range ( deg C)
(-) 90 to 230
Pressure (Kilo Scale)
Full vacuum to 0.5 bar(g)(Glass)
Full vacuum to 6.0 bar(g)(Glass lined)
Reactor bottom pan
Single Jacket Glass Reactor (Capacity) ( Litres)
10 to 100
Double Jacket Glass Reactor (Capacity) ( Litres)
10 to 100
Stainless Steel Jacket Reactor with Pre-insulation (Capacity) (Litres)
