Thermal Validation Systems温度、湿度、压力验证系统
It is essential to identify the coolest and hottest part of the load or area and calculate deviations and fluctuations. Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its Interval Calculations 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 (RTDs, 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 thermal validation study. RTDs and thermistors require less frequent checking, usually periodically, every 6 months.
Generally speaking 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 system 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 TQSoft™ thermal 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 thermal validation process. TQSoft™ thermal validation system software tracks Sensor Usage and allows engineers to set limits.
Because of the variety and variation of processes run within sterilization and disinfection chambers, 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™ Interval Calculation feature can be used to track critical parameters, such as A(0), F(0), Mean Kinetic Temperature, and immediately highlight any test data that is not within specification.
TQSoft™ thermal validation system 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 system 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 system software can help achieve these accuracies by providing simple to operate automated calibration and calibration…
热验证系统
随着温度的变化，灭菌和加工过程可能会出现问题。
识别负载或区域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间隔计算功能提供灵活性。
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。无论使用什么传感器（RTD、热敏电阻或热电偶），校准和校准检查操作程序对于正常可接受的验证实践都是必不可少的。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。应在热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™ 热验证系统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 TQSoft™ 热验证研究之前，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，远程记录仪电池电量不足可能会导致热验证过程中出现昂贵的问题。 TQSoft™ 热验证系统软件跟踪传感器的使用情况并允许工程师设置限制。
由于灭菌和消毒室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™ 间隔计算功能可用于跟踪关键参数，例如 A(0)、F(0)、平均动力学温度，并立即突出显示任何不在规格范围内的测试数据。
TQSoft™ 热验证系统软件提供了报告和报告管理模块，可以为报告制作提供高度自动化，并允许构建、管理、转换为 PDF、通过电子邮件发送和存档报告。
TQSoft™ 热验证系统软件符合 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™ 热验证系统软件可以通过提供易于操作的自动校准和校准来帮助实现这些精度……
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。
Thermal Validation Systems温度验证系统
