抄録
A new method was developed to make water-based hydrophobic filter integrity tests (HydroCorr test) more reliable under varying temperature conditions. While water-based integrity tests including HydroCorr have been widely adopted in various sterile drug production processes, strict control of temperature of air and water (as test liquid) around the filter is required when using conventional integrity test instruments for this test. Changes in temperature directly affect water flow measurement by these instruments. Conducting the test for vacuum break filters on lyophilizers requires special considerations because filters are usually installed in machine rooms and are exposed to significant temperature changes throughout the process. This new In-line HydroCorr Test adopts a direct water flow measurement method with an accurate and in-line steamable water flow meter. Stability of the In-line HydroCorr Test incorporating this water flow meter is evaluated under various temperature conditions.
