How is your API being isolated?

As an integrated API manufacturer, PCI is fortunate to have three fully automated, jacketed, totally enclosed, agitated pressure filters (PFN) in its manufacturing facility.

Posted: June 1, 2012

API Manufacturing and Pharmaceutical Manufacturing

All of our commercial API’s and production material for cGMP clinical supply are isolated and dried on one of our three jacketed, pressure filters. Since each unit is of a different size we typically employ the right unit for the scale required. However, since all three units are manufactured by Guedu and have similar geometry’s, scale up from one unit to the next is usually linear, saving significant time and effort when production volumes increase.

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All three units operate in the same way and can thus facilitate a number of operations in one piece of equipment in an enclosed environment. The enclosed nature of the equipment means that a variety of different unit operations can be carried out without exposing the material to either the operations personnel or the immediate environment. Issues of exposure and cross contamination are completely eliminated. This is a big advantage over open top, Buchner type filters and centrifuges. In all three cases the agitated PFN filters are employed after all the reaction operations haven taken place and the material is being prepared to be isolated and dried. Besides filtration the PFN’s are also used to:

  • Re-slurry and wash the solids with solvent/water
  • Stir the solids to homogenize the batch
  • Re-slurry the material for transfer back to a reactor
  • Packing of the solids to help squeeze solvent (and impurities) out of the solids during filtration
  • Stirring of the solids to enhance drying.
  • Efficient vacuum drying

Our commercial unit is called PFN2. This Hastelloy filter has a 2 sq. meters of filtration area and is equipped with a dual utility jacket system allowing for either high heat or temperate vacuum drying. The vessel can hold nearly 750 gal of slurry at any one time and process in excess of 400kg of material. Convenient sample ports allow for in process sampling throughout the filtration and drying process. This unit is also housed in its own isolation suite adding further protection to products that are being isolated from cross contamination and unnecessary environmental exposure.

Our scale up and semi-works unit is called PFN1 and has 1 sq. meter of filtration area. This unit can hold up to 500 gallons of solvent and isolate batches up to 250 kg. This unit is coated with a flouropolymer coating allowing for the isolation of products that are contained in the most aggressive, corrosive systems. This versatile piece of equipment also has a dual jacket control system and lends itself to easy maintenance and cleaning which are all covered by our various manufacturing SOP’s.

 

Our pilot/developmental unit is called PFN3 and has .5 sq. meter of filtration area. It is a jacketed, agitated, pressure filter that we use to filter, wash, re-slurry, and finally dry compounds during development and small scale production. PFN3 is used exclusively with our 7 vessel pilot system consisting of our 50-200gal reactors. All of the internal contact surfaces are constructed of Hastelloy C-276 and the jacket and peripherals are constructed of 316-stainless steel. It has a nominal liquid volume of 200 gallons, a mixing volume of 50 gallons and depending on the bulk density of the material it can process anywhere from 10-150kg of product.

 

If you have a project that calls for the manufacture of a highly toxic, hydroscopic, or air sensitive compound the PFN is the ideal piece of equipment to isolate and dry it. Alternatively, if your products (or quality requirements) are sensitive to cross contamination or environmental exposure the versatile and high performance PFN’s may be the answer you’re looking for. Please call our Business Development Team to see how our jacketed, pressure, filter dryers can help you manufacture your next API.

About the Author

Ed Price CEO of PCI Synthesis
Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst. Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).

Do you have questions? Talk to Ed.