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This system enables the final packaging of an API in a contained (< 1 µg/m3) and GMP manner without the requirement of a clean room around the filling area.
The system is designed in a way that the contamination of the powder from outside atmosphere or the exposure of the operator is at all times prevented.
The discharge of the filter dryer (or other process equipment) is carried out by the PTS Feeder which is installed on load cells. The system allows transferring and dosing powder accurately and directly into drums. All the dosing procedure is fully automatic.
The powder is directly sucked out of a dryer and transferred online through a conical mill.
The product is filled into a continuous liner installed into a compact glove box (DCS Drum Containment System). The system comprises an inlet and an outlet HEPA filter. The DCS glove box itself can be set under positive or negative pressure according to process requirements.
The drums are brought under the DCS and are sealed to the system by a pneumatic lifting system. An external liner is used to connect/disconnect the drums to the DCS in a contained manner. The area below the glove box is closed from three sides. The rear panel is provided with a positive air flow preventing contamination of this area from external impurities.
During the filling of the drum it is also possible to take samples automatically and directly out of the Feeder by a special Sampling System installed beside the unit.
The continuous liner cartridge can also be changed in a contained manner. In order to facilitate the installation of the liner, two operators can work together from each side of the unit.
The whole system can be cleaned in place.
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