Calculation of Leak Rate

 

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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

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