As it stands, current acceptance criteria are generally based on equipment capability – perhaps proposed by the manufacturer, or from data collected during qualification of a new freeze - dryer. The targeted specification is often one cited by The Parenteral Society, “A frequently specified leak rate for new, clean, dry, and empty freeze - dryers would be 2 x 10 - 2 mbar - liter/sec (15 μm (mTorr) liters per sec). The leak rate should not change significantly during the life of the freeze - dryer ...”.
DOWNLOAD THE WHITE PAPER >>>>>