The Parenteral Drug Association has released a revision of 

Parametric Release of Pharmaceuticals and Medical Device Products Terminally

The revised report, originally published in 1999, provides current best practices of the sterile product release method and emphasizes the use of science-based approaches when developing a parametric release program for “pharmaceutical and medical device products terminally sterilized by moist heat.”

The original TR 30 outlined a sterility assurance release program that utilized effective control, monitoring, and documentation of a validated sterile product manufacturing process dependent on achievement of critical operational parameters instead of end product sterility testing.   A group of international industry scientists, microbiologists, and engineers participated in the revision of TR 30.

 PDA members can access TR 30 for free until June 15, 2012.

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PDA Revises Technical Report on Sterilized Products