PDA Revises Technical Report on Sterilized Products - - BioPharm International

ADVERTISEMENT

PDA Revises Technical Report on Sterilized Products



>

The Parenteral Drug Association has released a revision of Technical Report 30 (TR 30), Parametric Release of Pharmaceuticals and Medical Device Products TerminallySterilized by Moist Heat.

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.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

FDA Panel Unanimously Backs Secukinumab for the Treatment of Psoriasis
October 22, 2014
Roche to Expand and Improve its Basel Site
October 22, 2014
Pall ForteBio Releases Bioprocessing Contamination Detection Kit
October 22, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9
October 20, 2014
Author Guidelines

Click here