PDA TR 30

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 report. 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 devices.