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Pharmaceutical requirements Sterility
Filtration
• It depends on the physical removal of microorganisms by
adsorption on the filter medium
• It is used for heat-sensitive solutions.
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Pharmaceutical requirements Sterility
Filtration: limitations
• Medicinal preparations sterilized by this method must undergo
extensive validation and monitoring because the effectiveness of
the filtered product can be greatly influenced by the microbial load in
the solution being filtered.
• Macromolecules, such as proteins and peptides, may be damaged
by filtration due to shear stress.
• Formulation might affect filter integrity and clogging. In addition,
some filters adsorb drug.
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Salma E. EL-Habashy 26
