Autoclave Validation 高压灭菌釜验证
大多数国家都有高压灭菌器验证的法规要求。尽管高压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完成。验证被定义为获得、记录和解释结果的文件化程序，以确保灭菌过程已经并将持续有效。
高压灭菌器的热验证包括在整个过程中精确测量高压灭菌器室内关键点的温度。灭菌过程的温度从液体灭菌的121℃到干热灭菌过程的300℃不等。高压灭菌器需要将其装载的所有部件加热到规定的温度并持续规定的时间，以达到所需的无菌状态。无菌度的置信度可以用致死率公式或“热死亡时间”来表示。TQSoft热验证系统可以自动计算关键操作参数并发出警报区间计算特色。
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TQSoft热验证系统被大多数领先的热压罐验证公司以及英国领先的培训机构用于HTM2010 HTM01-01以及EN554和EN285合规性
TQSoft热验证系统被大多数领先的热压罐验证公司和领先的培训机构所使用…
There is a regulatory requirement for autoclave validation in most countries. Although autoclave 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 sterilization process has been and will be consistently effective.
Thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process. Process sterilization temperatures can vary from 121°C for a fluid sterilization to over 300°C for dry heat sterilization processes. The autoclave 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.
For more information please visit our Thermal Validation Systems page.
The TQSoft™ thermal validation system is used by most leading autoclave validation companies, and at leading training establishments in the UK for HTM2010 HTM01-01 and EN554 and EN285 compliance.
The TQSoft™ thermal validation system is used by most leading autoclave validation companies, and at leading training establishments…
Autoclave Validation 高压蒸汽灭菌验证
