Calculation of Leak Rate
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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