Achieving Balance in Sterile Product Manufacturing

Agalloco, James; Akers, James
December 2015
Pharmaceutical Technology Europe;Dec2015, Vol. 27 Issue 12, p28
Trade Publication
Validating sterile product manufacturing processes requires the use of biological indicators to demonstrate the lethality of sterilization techniques. The indicator organisms are there merely to measure the effect of the sterilization process. Today, too much focus on lethality to biological markers results in use of extreme sterilization conditions; insisting on excessive lethality requirements in sterile process validation threatens patient safety, the authors believe. Not only does the practice subject process equipment and raw materials to damaging conditions, it can lead drug manufacturers to opt for aseptic processing in cases where terminal sterilization would be the best and safest choice. Companies should be free to choose the best way to ensure a safe process, whether that is aseptic processing, terminal sterilization, or a combination of the two.


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