Depyrogenation 干热灭菌/除热原
大多数热原是内毒素，虽然内毒素相对热稳定，但在干热灭菌器中将温度保持在250°C 30分钟可以显着降低内毒素水平。
去热原过程是一个关键的制药过程，大多数国家都有对该过程进行验证的监管要求。尽管去热原验证要求和质量保证要求在细节上有所不同，但共同主题是必须证明已实现去热原。验证被定义为获取、记录和解释结果的书面程序，以确保去热原过程已经并将持续有效。
有关更多详细信息，请访问我们的 热验证系统 页面。
大多数热原是内毒素，虽然内毒素相对热稳定，但内毒素水平显着降低...
欲了解更多信息，请联系我们的产品经理和验证工程师
Tel：021-68902733,18302112429
TQSoft热验证软件在这样的质量管理体系中可以发挥重要作用。TQSoft有一个测试设备数据库
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.
Most pyrogens are endotoxins, and although endotoxins are relatively thermally stable, a significant reduction in endotoxin levels…
Depyrogenation 除热原
