Stability Chamber Validation稳定性考察室验证
Naturally it is essential to demonstrate that a chamber can in fact control these parameters within a specified accuracy, at all points in and around the chamber, over a time period specified.
Stability chamber can vary in size, and often they are used to store critical pharmaceutical product. After the initial validation exercise many companies proceed to monitor these chambers with alarms on the critical parameters. Strictly these chambers should operate with levels of assurance similar to those achieved in the validation of autoclaves. So a periodic re-validation exercise is necessary.
Stability chamber temperature ranges can vary from 40°C to -80°C. TQSoft™ can perform validation studies with industry standard recorders such as those from Yokogawa. Recorders are often the best choice because they can be setup easily with TQSoft™ to calibrate and map temperature, humidity and luminescence with one unit.
TQSoft™ with MadgeTech can be used to map temperature and TQSoft™ with TMI can be used for temperature and humidity.
TQSoft™ offers the validation engineer great flexibility because it can combine data from different measurement sources into a single 21CFR compliant audited chart and data report.
The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and calibration checking 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 thermocouple and logger usage and allows engineers to set limits.
TQSoft™ Interval Calculations feature can be used to setup Mean Kinetic Temperature calculations on any group of sensors over any interval of time.
TQSoft™ Interval Calculations feature can be used to track critical parameters and immediately highlight any test data that is not within specification.
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.
Stability chamber temperature ranges can vary from 40°C to -80°C. TQSoft™ can perform validation studies with industry standard…
稳定室验证
稳定室旨在控制温度、湿度和辐射水平等环境参数。
当然，有必要证明腔室实际上可以在指定的时间内在腔室内及其周围的所有点将这些参数控制在指定的精度内。
稳定室的大小各不相同，通常用于储存关键的药品。在最初的验证工作之后，许多公司继续监控这些室，并针对关键参数发出警报。严格地说，这些室的运行保证水平应类似于高压灭菌器验证中所达到的保证水平。因此，定期进行重新验证是必要的。
稳定室温度范围为 40°C 至 -80°C。 TQSoft™ 可以使用行业标准记录仪（例如横河电机的记录仪）执行验证研究。记录仪通常是最佳选择，因为它们可以通过 TQSoft™ 轻松设置，以用一台设备校准和绘制温度、湿度和发光图。
带有 MadgeTech 的 TQSoft™ 可用于绘制温度图，带有 TMI 的 TQSoft™ 可用于绘制温度和湿度图。
TQSoft™ 为验证工程师提供了极大的灵活性，因为它可以将来自不同测量源的数据合并到一个符合 21CFR 标准的审核图表和数据报告中。
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操作简单、自动化的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。
TQSoft™ 间隔计算功能可用于在任何时间间隔内对任何组传感器设置平均动态温度计算。
TQSoft™ 间隔计算功能可用于跟踪关键参数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。
稳定室温度范围为 40°C 至 -80°C。 TQSoft™ 可以按照行业标准进行验证研究……
THP Validator无线温湿度验证记录仪可以进行温湿度分布验证检测和确认
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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。
Stability Chamber Validation稳定性考察室验证
