MascoLab

A viability test is performed by directly inoculating the test microorganisms into the product for the duration of the process; this allows for the definition of the test design for a bacterial challenge.

To demonstrate that the filtration process generates a sterile effluent and consistently removes a high level of standard bacteria (Brevundimonas diminuta, ATCC 19146) or process isolate, suspended in the product or surrogate fluid. The test is performed on a laboratory scale, optimizing the required process fluid volume and applying simulated worst-case process conditions.

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To demonstrate that the filtration process and product do not alter the physical structure of the filter. The process filter is exposed to the product for the duration of the process, applying simulated worst-case process conditions. The compatibility between the product and the filter is evaluated through an integrity test (for sterilizing-grade filters), visual inspection, and key physical dimensions.

To demonstrate that the filtration process does not alter the quality of the drug product under simulated worst-case process conditions. Both non-specific (NVR and FTIR) and specific (GC/MS, Q-TOF, and ICP/MS) analytical techniques can be performed to evaluate the presence of extractable compounds potentially toxic to patients. Semi-quantitative analyses are applied to detect and quantify a wide range of extractable compounds. Based on the extractables results, a specific toxicological assessment can be conducted, and if needed, a leachables test can be performed.

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