The isolator was designed to permit the dispensing and weighing activities of micronized highly potent substances (progesterone OEL 0,01 mg/m3 ).
Highlights
Fully PLC controlled
Software GAMP 5 compliant
Friendly operator interface
Sliding Tray
Pass through door for communication with adjoining chamber
190 mm glove flanges with gloves
270 mm glove flanges with gloves
Continuous film port Diam. 380 mm
rH+T sensor for temperature and humidity internal monitoring
Magnahelic Manometers for the internal pressure control
Inverter for ventilation fan speed control
Automatic valves for air flow interception
Jumo Manometers to monitor inlet and outlet filters obstruction
This compact isolator is mainly constitute of two chambers:
Pre chamber: to inlet material
Main chamber: where to perform dispensing activities
Both the chambers are equipped with an inlet single stage filtration placed inside the box, an outlet first stage filtration also inside and the second one outside. The isolator is also equipped with a special CIP system consisting in spray balls, spray guns and a solvent mixing system. Moreover a Drying In Place has been supplied on board with independent heaters, humidity and temperature probe inside each chamber.
One 380mm diameter continuous liner port has been placed on the side of each chamber to easy exit large drum where the product is stored while only in the main chamber there is an integrated Hycoflex® system to take out the dispensed product.
A paperless recorder Eurotherm was also integrated to record all the critical process data like temperature, humidity, chamber pressure.