Installs a GFD Filterbox at an active pharmaceutical ingredients manufacturer in Queensland, Australia
Powder Systems Limited (PSL), an international manufacturer of filtration, drying and high containment isolators for the pharmaceutical and biopharmaceutical industries, has delivered a high containment filtration and drying installation in Australia.
The project consists of a small scale pressured agitated nutsche filter dryer in glass integrated in a high containment isolator, called the GFD FilterBox, achieving an OEL (Occupational Exposure Limit) of less than 1 microgram per metre cube 8 hours Time Weighted Average.
The FilterBox achieves containment to nanogram levels protecting both the product and the 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 FilterBox provides a more compact design than traditional separate agitated nutsche filter dryer and containment products, reducing floor space requirement and impact on plant design, says PSL. The FilterBox solution is easily scalable from laboratory to industrial production.
The GFD FilterBox includes a Maxi Lab GFD
The GFD FilterBox being installed in Queensland, Australia, includes a Maxi Lab GFD with a filtration area of 0.05m2 for 5L 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 its production plant extension, the Australia-based API manufacturer is using the GFD FilterBox in its key hub conducting on-going research and development and clinical studies on the group product portfolio, providing the active ingredient for one of its products to Australia and the rest of the world.
PSL established its Asia-Pacific operations in 2014 with an office in Perth, Australia and recently in Singapore to support the increasing 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 high potent API manufacturing will be installed in 2016 such as the PSL Monocell for charging operations in Singapore.