Non-heat terminal sterilization of controlled released material

Apr 9, 2015
Presentation overview - A balance must be achieved between the need to maintain a safe, stable and efficacious product while providing sufficient lethality to attain a minimum level of sterility assurance •No sterilization method should be considered exempt •Sterilizing processes should be a compromise between the degradation effect on the materials and destruction of microorganisms •A sterilization process that destroys all microorganisms, but renders the item being sterilized unfit for use is of no value •The sterilization process and the specific product, formulation and container must all be suited to each other • There are few universal answers, and some of those that appear to be broadly applicable may be wrong.
Author: Agalloco, James.
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