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