Radiopharma
Pharma
ATMP Cell & Gene Therapy
Services
Production management system for both single isolators and complex production lines »
The isolator was designed to permit the dispensing and weighing activities of micronized highly potent substances (progesterone OEL 0,01 mg/m3 ).
This compact isolator is mainly constitute of two chambers:
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.
