Assuntos
Filtração/métodos , Membranas Artificiais , Soluções Farmacêuticas/normas , Esterilização/métodos , Tecnologia Farmacêutica/métodos , Contaminação de Medicamentos/prevenção & controle , Filtração/instrumentação , Tamanho da Partícula , Porosidade , Medição de Risco , Esterilização/normas , Tecnologia Farmacêutica/instrumentação , Tecnologia Farmacêutica/normasRESUMO
There are a multitude of filter designs and mechanisms utilized within the biopharmaceutical industry. Prefilters are commonly pleated or wound filter fleeces manufactured from melt-blown random fiber matrices. These filters are used to remove a high contaminant content within the fluid. Prefilters have a large band of retention ratings and can be optimized to all necessary applications. The most common application for prefilters is to protect membrane filters, which are tighter and more selective than prefilters. Membrane filters are used to polish or sterilize fluids. These filters need to be integrity testable to assess whether or not they meet the performance criteria. Cross-flow filtration can be utilized with micro- or ultrafiltration membranes. The fluid sweeps over the membrane layer and therefore keeps it unblocked. This mode of filtration also allows diafiltration or concentration of fluid streams. Nanofilters are commonly used as viral removal filters. The most common retention rating of these filters is 20 or 50 nm.