Sterile Contained PM8 Micronizing systems

September 22, 2016

One of the most important projects of this year has been the construction of a production scale sterile contained micronisation system that was delivered to a pharmaceutical manufacturer in Spain last July.

The equipment, designed to be installed across different floors, is composed of a glovebox to discharge the batches from a filter dryer without affecting the product sterility; a jet mill isolator provides a confined environment in which the product is micronised; downflow booths are integrated on the airlocks of the pack-off isolator to guarantee the high sterility grade.

The system is fully automated. FPS internally develops the software that controls all the equipment functionalities. The machine is sterilised with both hot steam and VHP.

The ground-breaking unit will allow the customer to complete different phases of a sterile production of APIs avoiding the risk of contaminating the product and reducing the operator’s exposure to the potent compound.

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