Applied Statistics in the Pharmaceutical Industry pp 457-474 | Cite as
Evaluation of the Decimal Reduction Time of a Sterilization Process in Pharmaceutical Production
Abstract
Consider measuring the effectiveness of sterilization during the production of a pharmaceutical substance. The decimal reduction time, D-value, of a sterilization process is defined to be the time required to reduce the number of microorganisms present by a factor of 10. Because the issue of concern is the rate of bacterial death this process is often referred to as “Death Kinetics.” Different methods for sterilization are possible depending on the nature of the pharmaceutical product, for example, heat treatment. Since the D-value depends to a large extent on environmental conditions, it is necessary to determine experimentally the substance specific D-value for each substance that is sterilized by means of moist heat. If the D-value of the substance is the same as that of a reference substance, typically water, the sterilization process is deemed successful.
Keywords
Test Substance Microbial Count Sterilization Process ASCII File Individual AssayPreview
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