Most pyrogens are endotoxins, and although endotoxins are relatively thermally stable, a significant reduction in endotoxin levels can be achieved by holding temperature at 250°C for 30 minutes within a dry heat sterilizer.
The process of Depyrogenation is a critical pharmaceutical process and there is a regulatory requirement for validation of the process in most countries. Although depyrogenation validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that depyrogenation has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the depyrogenation process has been and will be consistently effective.
For more details please visit our Thermal Validation Systems page.