KiloLab Laboratory: strategic milestone achieved!

KiloLab Laboratory – a development and production in a kilogram scale – has been launched, according to Polpharma API development strategy adopted in 2021.

The new facility is adapted to GMP conditions and allows work with products with OEL>200 ng/m3(so-called High Potent API – OEB category 5).

KiloLab has almost 120 m2 of production space and over 150 m2 of technical space with installations supporting KiloLab.

The production line includes:

1) Isolator (2 chambers: Weighing & Drying ) Drying chamber is equipped with:
* Nutsche-filter;
* Tray dryer;
* Mill with a wide range of PSD capabilities.

2) Reactors:
* Glass reactor system with a volume of 30 Liters, operating in the temperature range -40*C – 200*C;
* CRYO glass reactor system with a volume of 25 Liters, operating in the temperature range -80*C – 200*C;
* Enamelled reactor system with a volume of 63 Liters, operating in the temperature range -40*C – 200*C;

Due to the production of HP API, all reactor systems were enclosed in RABS – a special system that increases operator safety through constant negative pressure and glove ports.

Author: Michal Sulkowski, Senior Industrial Engineering Specialist Engineering and Maintenance Department API Business Unit