Another Polpharma API 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 -400C – 2000C;
- CRYO glass reactor system with a volume of 25 Liters, operating in the temperature range -800C – 2000C;
- Enamelled reactor system with a volume of 63 Liters, operating in the temperature range -400C – 2000C;
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.
KiloLab project is another investment increasing the competitiveness and production and development capabilities of Polpharma API.
Author: Michal Sulkowski, Senior Industrial Engineering Specialist Engineering and Maintenance Department API Business Unit