Sterilizer Validation灭菌器验证与确认
Although 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 consists of accurately measuring the temperature at critical points within the sterilization 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 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.
Problems with sterilization can occur with the spread of temperatures within the load. It is essential to identify the coolest and hottest part of the load and calculate deviations and fluctuations. Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its I-Calc feature.
The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.
Generally thermocouple accuracy is required to be +/- 0.5°C. For Dry Heat Sterilization (or Hot Air Sterilization or Depyrogenation 200°C to 400°C) accuracy is generally required to be +/- 1.0°C.
TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.
Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.
Because of the variety and variation of processes run within sterilizers, validation engineers should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. This is periodic revalidation. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.
TQSoft™ thermal validation software provides a Reporting and Report Management module which can provide a large degree of automation to report production, and allow reports to be built, managed, converted to PDF, emailed and archived.
TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.
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.
Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its I-Calc feature…
灭菌器验证
室内灭菌过程是一个关键过程，大多数国家都有对该过程进行验证的监管要求。
尽管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，以确保灭菌过程已经并将持续有效。
热验证包括在整个过程中准确测量灭菌室内关键点的温度。工艺灭菌温度范围从液体灭菌的 121°C 到干热灭菌工艺的 300°C 以上不等。灭菌器需要将其负载的所有部分加热到指定温度并持续足够长的指定时间，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。
随着负载内温度的扩散，可能会出现灭菌问题。识别负载的最冷和最热部分并计算偏差和波动至关重要。许多公司对分析都有自己的想法，TQSoft™ 热验证系统可以通过其 I-Calc 功能提供灵活性。
用于执行热验证的传感器和数据采集硬件的准确性至关重要。校准和校准检查操作程序对于正常可接受的验证实践是必不可少的，无论使用什么传感器（RTD、热敏电阻或热电偶）。验证报告必须表明热电偶、传感器、校准和数据采集设备已根据可追溯标准定期进行检查。应在验证研究之前和之后检查热电偶。 RTD 和热敏电阻需要的检查频率较低，通常每 6 个月定期检查一次。
一般来说，热电偶精度要求为 +/- 0.5°C。对于干热灭菌（或热空气灭菌或去热原 200°C 至 400°C），精度通常要求为 +/- 1.0°C。
TQSoft™ 热验证软件可以通过提供易于操作的自动校准和校准检查程序和报告来帮助实现这些精度。 TQSoft™ 还将所有验证和校准设备详细信息存储在测试设备数据库管理系统中。在验证研究之前，工程师可以勾选正在使用的设备项目，TQSoft™ 将此信息存储在每个验证记录中。这允许用户创建有关校准或验证设备的各个项目的审核报告。
热电偶的使用寿命有限，远程记录器电池电量不足可能会导致验证过程中出现昂贵的问题。 TQSoft™ 热验证软件跟踪热电偶和记录仪的使用情况，并允许工程师设置限制。
由于灭菌器内运行的过程多种多样，验证工程师应该有一种方法来存储测试参数和计算，以便能够快速有效地重复测试和重现报告。这是定期重新验证。 TQSoft™ 热验证系统提供了一个“测试规范”数据库，可以重复使用并轻松适应新的要求。
TQSoft™ 热验证软件提供了报告和报告管理模块，该模块可以实现报告制作的高度自动化，并允许构建、管理报告、转换为 PDF、通过电子邮件发送和存档报告。
TQSoft™ 热验证软件符合 FDA 21CFR 第 11 部分中关于电子签名的规定，并根据 GAMP 进行开发和维护。
TQSoft™ 热验证系统被大多数领先的高压灭菌器验证公司以及英国领先的 HTM2010 HTM01-01 以及 EN554 和 EN285 合规性培训机构所使用。
许多公司对分析都有自己的想法，TQSoft™ 热验证系统可以通过其 I-Calc 功能提供灵活性……
THP Validator无线温度检测仪可以进行灭菌器空载、满载热分布、满载热穿透温度热分布验证与确认
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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。
Sterilizer Validation灭菌器验证与确认
