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Sterile Filtration

Author(s):  Akers Michael J

Issue:  Sep/Oct 2015 - Volume 19, Number 5
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Page(s):  393-401

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Abstract:  The great majority of sterile products commercially available as well as prepared in compounding pharmacies are sterilized by sterile filtration during aseptic processing. This brief and basic review will highlight the nature, action, and use of sterilizing filters. Special emphasis is given to how filters are validated in producing a sterile filtrate while being compatible with the filtered solution, as well as how filters are integrity tested during aseptic processing.

Related Keywords: Michael J. Akers, PhD, compounded sterile preparations, sterile filtration, particle filters, microfilters, ultrafilters, nanofilters, filter porosity, filter efficiency, filter material, filter membrane thickness, filter validation, bacterial retention destructive testing, in process filter integrity testing, bubble-point test, diffusion test, forward flow test, retention test apparatus, microbe contamination, microbial reduction, surface-active agents, amphiphilic wetting agents

Related Categories: STERILE PREPARATIONS, TECHNOLOGY, QUALITY CONTROL

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