EtO Sterilization Validation环氧乙烷灭菌
Consequently, validation exercises must verify that temperature remains within specified parameters. Other critical parameters are pressure and humidity.
Because of the concerns about the chamber seals, remote battery powered loggers are generally preferred for EtO sterilization validation over thermocouple and transducers cabled to an exterior data acquisition device. Loggers such as TMI-Orion NanoVacq Ex are better suited to the application. TQSoft™ thermal validation software is compatible with TMI loggers.
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.
TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration check 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 Sensor Usage and allows engineers to set limits.
There is a wide variation in the size of EtO chambers and the processes specified within the chamber. Because of this, validation engineers performing EtO sterilization validation should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. 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 compliance with FDA regulation on electronic signatures in 21CFR Part 11 and Audit Trail Management and has been developed and maintained according to GAMP. Tamperproof File Security is implemented.
TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and…
因此，验证练习必须验证温度是否保持在指定的参数范围内。其他关键参数是压力和湿度。
由于对腔室密封的担忧，与连接到外部数据采集设备的热电偶和传感器相比，远程电池供电的记录仪通常更适合用于 EtO 灭菌验证。 TMI-Orion NanoVacq Ex 等记录仪更适合该应用。 TQSoft™ 热验证软件与 TMI 记录仪兼容。
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。
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 传感器的使用情况并允许工程师设置限制。
EtO 室的尺寸和室内指定的工艺有很大差异。因此，执行 EtO 灭菌验证的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。 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™ 热验证软件符合 FDA 关于21CFR 第 11 部分中电子签名和审计跟踪管理的规定，并根据 GAMP 进行开发和维护。实现了防篡改文件安全。
TQSoft™ 热验证软件符合 FDA 对 21CFR 第 11 部分中电子签名的规定
THP Validator 可以进行环氧乙烷灭菌的温湿度分布验证检测。
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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。
EtO Sterilization Validation环氧乙烷灭菌
