Oven endotoxins, or endotoxin indicators, are used to verify dry heat depyrogenation processes.
According to the Pharmacopoeia, depyrogenation is performed by applying a cycle of at least 250°C for 30 minutes. The cycle must be validated for its specific intended use.
Passing glassware and resistant materials through high-temperature ovens or tunnels is ideal for depyrogenation.
Validation involves checking physical parameters, such as temperature, and biological parameters, i.e., the ability to achieve a reduction of endotoxin content by at least 3 logarithms. For example, a reduction from 10,000 EU to 10 EU is considered valid.
To demonstrate the reduction, oven endotoxins are first subjected to depyrogenation and then tested with the LAL test to determine the residual endotoxin content. The result is compared in parallel with that of untreated indicators.
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