Isolator for weighing and dispensing of micronized substances
Handling highly potent micronized substances, such as progesterone, in pharmaceutical processes requires a controlled environment to ensure operator safety and process accuracy.
Control micronized substance weighing and dispensing
The isolator by Comecer is designed for precise weighing and dispensing of highly potent micronized substances, with an OEL of 0.01 mg/m³. It features fully PLC-controlled operations and GAMP 5 compliant software, ensuring accurate and safe procedures. The isolator includes a pre-chamber for material inlet and a main chamber for dispensing activities, both equipped with single and dual-stage filtration. It also has a continuous liner port for easy exit of large drums, along with an integrated Hycoflex® system in the main chamber for product removal. Internal conditions are monitored using a combination of Magnahelic manometers for pressure control, an rH+T sensor for humidity and temperature, and Jumo manometers for filter obstruction monitoring. The system also includes CIP components like spray balls and guns, along with a Drying In Place feature enhancing the overall cleaning process. A Eurotherm paperless recorder captures critical process data for compliance and record-keeping.
Benefits
- Enhanced operator safety with controlled environment
- Accurate weighing facilitated by PLC-controlled system
- Comprehensive internal condition monitoring
- Efficient product removal with integrated Hycoflex® system
- Reliable data recording with Eurotherm paperless recorder