By Dec Group
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Dec Group High Containment Pack-Off solution
Dec Group has developed a Pack-Off station that can ensure safe packing of the most highly toxic Occupational Exposure Band (OEB) 5 materials without need for a dedicated clean room or full enclosure.
The whole system is also adapted for easy clean in place (CIP) and is suitable for use in highly inflammable or explosive ATEX Zone 1/21.
Revolutionary Pack-Off solution
When it comes to packing toxic API products, powders must be packed under a controlled atmosphere and at the same time operators must be protected from product exposure. In the past this has meant that the packing system had to be installed in a clean room and fully contained by enclosure.
The Dec Pack-Off system enables final packing of APIs in a contained and GMP manner using a stand-alone station that can be located in the main production area.
The system consists of a compact glove box including an integrated CLS Continuous Liner System. The cabinet includes a laminar flow system and a lifting system to seal the drum to the liner head.
The glove box includes an inlet and an outlet HEPA filter and can be set under positive or negative pressure according to process requirements.
High containment features
Drums are brought into the pack-off cabin and are then sealed by the pneumatic lifting system, with external liner used to connect or disconnect the drums in a contained manner. The area below the glove box is closed from three sides.
The rear panel is provided with an outward air flow preventing contamination of this area from external impurities. This can be switched to inward air flow during drum filling when handling highly toxic powders to prevent contamination.
The continuous liner cartridge can also be changed in a contained manner and in order to facilitate the installation of the liner, two operators can work together from each side of the unit.
Dec’s Pack-Off solution comprises the Group’s unique unified transfer/dosing concept in which one filling station can service several different pieces of equipment.
The Pack-Off system can be installed directly under the process equipment to be discharged. Alternatively, powder can be transferred by using PTS when installed in a remote area.
- Load cells for precise dosing when using PTS with DosiValve®
- Mill or sieve integrated in the filling line
- Automated, representative sampling out of the system by using MPTS Sampling Device
The system prevents product contamination from the outside atmosphere as well as operator exposure at all times. This concept, validated by competent authorities, allows to handle OEB 5 materials (0.1-1 µg/m3) as it comprises primary and secondary containment with an additional level of safety.
Dec Pack-off station: full containment without need for clean room or enclosure
MPTS Sampling Device for inline and sterile sampling