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Dry heat sterilization


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 a carrier spiked with endotoxin) designed for use in depyrogenation studies. Endotoxin on a carrier is added at a concentration sufficient to allow recovery of a minimum of 1000 USP endotoxin units/ carrier. The endotoxin indicator would allow for accurate indication of at least a 3 Log reduction in USP endotoxin units during depyrogenation process challenges.


Tunnel Biological indicator ======Fix the thermocouples along with Biological indicator (Bacillus Atrophaeus) on the cooling chamber internal surface/belt by opening

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