The removal of micro-organisms from fluids by passage through filters is a complex process, and careful attention must be paid to the selection and validation of the filters, according to Dr Tim Sandle.
Filtration is a means of sterilising fluids (liquids or gases) through the removal, rather than the destruction or inactivation, of micro-organisms. Membrane filtration is a technology commonly used in pharmaceutical cleanrooms, particularly for liquids that would be damaged by heat irradiation or chemical sterilisation. The sterilisation of liquids by filtration is a key step for aseptic manufacturing prior to the dispensing of the product.
The characteristics of a sterilising grade filter are that it must be compatible with the process; be non-toxic; pass an integrity test; and be sterilisable (or provided sterilised). Furthermore, filters should not adsorb formula components or add extractables to the process and, most importantly, they must remove the bioburden associated with the product.
The removal of micro-organisms from fluids by passage through filters is a very complex process and is dependent on inter-actions relating to the chemistry and surface characteristics of the membrane, the micro-organisms, and the suspending fluid. Careful attention must therefore be paid to the selection and validation of filters.
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