Validation of cartridge filters and filtration processes

Published: 2-Oct-2015

Filter validation is critical to ensure patient safety and safeguard various process steps. However, different fluids can influence the extractables and filtration efficacy as Mozamal Nazir, Senior Scientist, Porvair Filtration, explains

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Manufacturers of cartridge filters validate their filters in house, in accordance with a standard methodology described in ASTM F8381 using Brevundimonas diminuta as the challenge organism; in brief, at a pressure of 2 bar, a sterilising grade membrane filter is challenged with bacteria grown in an aqueous buffer. A positive control filter of 0.45µm pore size is used to ensure that the bacteria grown are small enough to penetrate any defect in a 0.2µm filter.

It is important to note that both liquid and gas sterile filters in pharmaceutical processes are required to prevent the breakthrough of bacteria in a liquid challenge. Gas sterile filters are often wetted during the process, either inadvertently with the product, or during steam sterilisation. In both scenarios, a filter that is validated with a liquid challenge will ensure sterility.

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