In this article, Mike Stradling, Site Head, Sterile Cluster at Adragos Pharma Solutions, provides practical guidance for compliant, robust manufacturing and seeks to clarify some of the common misconceptions about the two options.
Terminal sterilisation involves sanitising the product in its final, sealed container with, usually, moist heat (steam).
The method offers the highest sterility assurance level and is explicitly preferred “whenever possible” by the European Pharmacopoeia and EU GMP Annex 1 because it is highly reproducible and minimises post-sterilisation contamination.
Contrary to common thinking, moist-heat cycles are not fixed at 121 °C for 20 minutes. They are primarily designed using F0 lethality and validated with Geobacillus stearothermophilus biological indicators and load-specific heat-penetration studies.
The often-cited F0 ≈ 12–15 minutes at 121 °C is an overkill benchmark. Lethality should be tailored to the load and packaging and justified by demonstrated D/z (decimal reduction time/temperature sensitivity) values and the target sterility assurance level (SAL).
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