PDA Technical report No. : 3 (Revised 2013) Dry heat process used for sterilization and depyrogenation. Bacterial Endotoxin Test (BET) - Assay for measuring active endotoxins by combining a liquid test sample with LAL (Limulus Amoebocyte Lysate) reagent and measuring the resulting proportional reaction via visual, turbidimetric, chromogenic, or other validated means of detection. BI Challenge system - A test system containing viable microorganisms of pure and specified strain providing a defined resistance to a specified sterilization process. Depyrogenation - Destruction and /or removal of bacterial endotoxins. It demonstrates at least 99.9 % or 3 Log endotoxins reduction. D- Value- Time in minutes required for a one-logarithm or 90% reduction of microorganisms used as biological indicator under specified lethal conditions. Dwell Time- Period that items are subjected to a given processing conditions. Endotoxin Indicator (EI) for depyrogenation - Vial of endotoxin (or ...