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- Title
A proposed scientific rationale and methodology for the establishment of acceptance criteria for leak rates in pharmaceutical freeze dryers.
- Authors
Jones, Ian Aled
- Abstract
A scientific rationale is proposed for the establishment of acceptance criteria for leak rates in pharmaceutical freeze dryers. A methodology has been developed to determine the theoretical quantity of air that could leak into a pharmaceutical freeze dryer and, based on the potential maximum bioburden and particulate level of the leaked air from potentially unclassified areas, calculations can be undertaken to determine the maximum allowable leak rate that will maintain Class 100/Grade A conditions for the duration of the lyophilisation cycle. It is shown that the 2 x 10-2 mbarlitre/s specification, that is frequently quoted as the acceptable leak rate for modern pharmaceutical freeze dryers, is not appropriate for freeze dryers of differing volumes with lyophilisation cycles of differing lengths.
- Publication
European Journal of Parenteral & Pharmaceutical Sciences, 2019, Vol 24, Issue 1, p20
- ISSN
1740-6277
- Publication type
Academic Journal