Calculation of Leak Rate


   Missing: Microsoft Office Web Components
This page requires the Microsoft Office Web Components.

Click here to install Microsoft Office Web Components..

This page also requires Microsoft Internet Explorer 4.01 (SP-1) or higher.

Click here to install the latest Internet Explorer.


The leak rate should relate to the total freeze dryer in operating conditions i.e. including all connections and fitted probes/gauges to both freeze drying chamber and ice condensor.


The leak rate on a clean and dry freeze dryer should be ≤ 2 x 10-2 mbar litres/second*.


It is recommended to perform a leak rate testing after each CIP/SIP on freeze dryers used to freeze dry aseptic products (drug ingredients and drug products).


On freeze dryers used for non-aseptic products it is as a minimum recommended to perform leak testing at least once every three month and/or whenever there has been disconnected any connection directly fitted on the freeze drying chamber and/or ice condensor


*Technical Monograph No. 7 "Leak Testing Of Freeze Dryers" published by The Parenteral Society





2010 PG Freeze Drying Consult