PH12 PharmASep Pharmaceutical Aseptic Separator
The PharmASep 300mm (PH12) lab Filter/Dryer allows batch processing up to 1 kg in size. The no-gap design and sealed environment allow for extremely high-yield product recovery and safe handling of highly potent pharmaceuticals. The unique, patented Vibro-Dry technology developed by SWECO allows vacuum drying to occur within the PharmASep while the product is gently tumbled on the screen surface, accelerating drying and reducing formation of agglomerates.
FILTER AND DRYER IN ONE MACHINE WITH VIBRO-ENERGY VACUUM DRYING TECHNOLOGY, CIP/SIP CAPABILITY, AND CLASS 100 CLEAN ROOM DESIGN
Aspetic batch filtration and washing of pharmaceutical solids
PHARMACEUTICAL ASEPTIC SEPARATOR
SWECO PharmASep™ Filter/Dryers were designed for the aseptic batch filtration and washing of pharmaceutical solids and for their further de-watering and drying. All processes are completed within the sealed chamber without any need for intermediate transfer, handling, or exposure to the external environment.
The PharmASep™ uses gentle, patented Vibro-Energy motion to promote fluid separation at low differential pressures. The motion is then combined with nitrogen purge to fluidize the bed of solids for gentle, efficient drying. No mechanical stirring devices are required. Solids are generally discharged as a flow-able powder with consistent dryness and free of lumps.
Once the screen is installed and the chamber is closed, SIP can be performed. When the chamber has cooled, product is introduced to the top (scalping) screen (1), which is used to remove occasional large particles or agglomerated solids from the product. Fines are carried through the top screen with the liquid and fall to the lower screen.
The lower (product) screen mesh is sized to retain particles above the desired size. The liquid phase passes through the mesh with the fines, leaving wet solids behind. The patented SWECO Vibro-Energy® motion promotes further dewatering and keeps the particles in motion. At the completion of the dewatering step, vacuum drying begins (2). Vacuum inside the chamber is set to a moderate level as dry nitrogen at a controlled temperature is introduced below the product screen. As drying proceeds, the solids spread evenly across the screen. The SWECO Vibro-Energy® motion continuously blends the solids to promote uniform drying while the nitrogen maintains temperature and carries away the moisture.
When separation and/or drying is complete, product discharge can begin (3). The product plug is retracted and the motion of the PharmASep™ is used to move the product across the top of the product screen to the discharge chute.
Following product discharge, the chamber can be wetted or rinsed as desired and the screens removed for inspection and cleaning. CIP Spray Balls can be inserted and CIP completed. After CIP, the spray balls are removed, clean screens are installed, the chamber is sealed, and SIP can be conducted (4) to begin the next cycle.
LAB AND PRODUCTION SIZES
With validatable CIP/SIP capability and class 100 clean room design
The SWECO PharmASep™ Filter/Dryer is available in lab-scale sizes that can be used to process up to 1kg (at .51 kg/m2 bulk density) of pharmaceutical-grade materials in an aseptic environment. The lab-friendly designs are capable of the complete flexibility that today’s R&D laboratories require. Results from the PH12 can be used to scale to production-size equipment.
» Chamber design is crevice-free and fully-drainable
» Interior Ra < 0.3 microns and electropolished
» Exterior Ra < 0.6 microns and passivated
» Temperature-control jackets available
» Certified explosion-proof motors
» Custom control panels available
» Hydraulic lift devices facilitate screen change and internal inspection
» ASME rated for full vacuum and internal pressure up to 30
» PSIG (2 bar)
» No internal scraping or rotating mechanical devices or seals
» Full line of PharmASep™ screens complete with certifications and traceability to suit your process needs