Dry Heat Sterilizer Validation干热灭菌器验证
使用干热灭菌是因为某些材料对湿气敏感。通常使用干热来确保玻璃和其他实验室设备不含热原材料。
腔室或热风通道内的灭菌过程是一个关键过程，大多数国家都有对该过程验证的监管要求。尽管干热灭菌器验证要求和质量保证要求在细节上有所不同，但共同的主题是必须证明灭菌已经实现。验证被定义为获取、记录和解释结果的文件化程序，以确保干热灭菌过程已经并将持续有效。
干热灭菌器验证包括在整个过程中准确测量灭菌室内关键点的温度。干热工艺通常采用 250°C 至 400°C 之间的温度并持续不同的时间。灭菌器需要将其负载的所有部分加热到指定温度并持续指定时间，足够长的时间以达到所需的无菌状态。然后可以通过致死率公式或“热死亡时间”来表达无菌程度的置信度。 TQSoft™ 热验证系统可以利用其间隔计算功能自动计算关键操作参数并发出警报。
欲了解更多信息，请访问我们的热验证系统页面。
TQSoft™ 热验证系统可以通过其 间隔计算自动计算关键操作参数并发出警报……
THP Validator无线温度检测仪可以进行干热灭菌的温度热分布、温度热穿透验证检测。
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。
Dy Heat Sterilization is used because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material.
The process of sterilization within a chamber or hot air tunnel is a critical process and there is a regulatory requirement for validation of the process in most countries. Although dry heat sterilizer validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the dry heat sterilization process has been and will be consistently effective.
Dry heat sterilizer validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process. Dry heat process generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified temperature for a specified period, long enough to achieve the desired sterility. The confidence of degree of sterility can then be expressed by a lethality formula or ‘thermal death time’. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.
Dry Heat Sterilizer Validation干热灭菌器验证
