PDA Technical Report No. 30 (Revised 2012): Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat provides current demonstrated best practices of this sterile product release method with an emphasis on use of science-based approaches during the development of a parametric release program for pharmaceutical and medical device products terminally sterilized by moist heat.
The original report was groundbreaking in that it espoused a rational
solution to the problem of the sterility test. Published originally in 1999, the
document outlined a sterility assurance release program that is founded upon
effective control, monitoring, and documentation of a validated sterile product
manufacturing process where sterility release is dependent upon demonstrated
achievement of critical operational parameters in lieu of end product sterility
testing. In this program, critical operational parameters and performance
attributes are determined for process steps that occur prior to and during the
performance of the sterilization process.
Since 1999, many regulatory
agencies and pharmacopoeial organizations across the globe have recognized the
use parametric release and have fostered its implementation through the
development of supporting standards, guidances and recommended practices. This
growing adoption of parametric release necessitated an update to the 1999
The task force that participated in revising TR-30 was comprised of
industry scientists, microbiologists and engineers from regions across the globe
to ensure scientifically sound best practices were presented regarding
parametric release of moist heat sterilized pharmaceutical products and medical
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