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The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.
Powder Systems Limited, a manufacturer of filtration, drying, and high-containment isolators for the bio/pharmaceutical industries, announced it recently delivered a high-containment filtration and drying installation in an Australian API manufacturing plant based in Queensland.
The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator-called the Glass Filter Dryer (GFD) FilterBox-achieving an occupational exposure limit (OEL) of less than 1 microgram per meter cube, 8-hour time weighted average.
The FilterBox achieves containment to nanogram levels protecting both product and operator during operations including charging, sampling, filtration, cake washing, drying, and discharging. The cleaning procedure is performed safely and thoroughly as the vessel base and the removable filtration basket can be easily accessed in a contained environment. Interconnecting nozzles and pipes can be dismantled without any containment breach for contained cleaning and maintenance.
The compact design of the FilterBox compared to the traditional separate agitated nutsche filter dryer and containment products means that floor space requirements as well as the impact on plant design are reduced. The FilterBox solution is easily scalable from laboratory to industrial production, according to Powder Systems Limited.
The GFD FilterBox being installed in Queensland, Australia, includes a MAXI LAB GFD with a filtration area of 0.05m2 for 5-L product volume. The GFD works under vacuum and pressure, up to 4 bar with metallic vessels, for an efficient filtration and drying of any slurry assisted with a heated jacket for fast drying. The unique removable filtration basket allows for a full recovery of the final dried cake, safely through the gloves and window of the isolator.
The cake is then harvested and can be weighted inside the isolator for dispensing and packing purposes. The final product and instruments are transferred via an airlock, bag out port and continuous liner systems or Rapid Transfer Port.
As part of their production plant extension, the Australian-based API manufacturer is using the GFD FilterBox in its key hub conducting R&D and clinical studies on the group product portfolio, providing the active ingredient for one of their products to Australia and the rest of the world.
Powder Systems Limited started operations in Asia-Pacific in 2014. The company has offices located in Perth, Australia and recently, Singapore to support the demand for advanced process technologies in the region.
This first project marks the beginning of a successful expansion for PSL APAC in Australia. More isolators for highly potent API manufacturing will be installed in 2016 such as the PSL Monocell for charging operations in Singapore.
Source: Powder Systems Limited