Page 49 - Assurance of Sterility for Sensitive Combination Products and Materials

Terminal sterilization 37

gas, and dry/moist heat, allowing robust sterilization cycles to be developed.
An in-depth understanding of microbial loading along with microbial re-
sponse to the sterilant resulted in conservative cycles that produced safe
products. Innovative new products are pushing current sterilization tech-
nology to the limits, as developers are challenged to address new materials,
and new drugs with complex designs. These advances are pushing the ster-
ilization technology to new limits. As developers continue to innovate in
areas such as controlled drug delivery, sensitive combination product that
provide multiple benefits, and the incorporation of electronics into devices,
the sterilization technology and validation strategies will have to be as in-
novative to match the needs of these devices.

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