Storage Area Validation仓储库房温湿度验证
Data is collected and analyzed for cold spots or hot spots. Mapping tests must be made on empty chambers and fully loaded chambers. Most types of chambers require this treatment from incubators and storage areas and warehouses to autoclaves, EtO chambers, stability chambers, tunnels, dry heat sterilizers. Mapping must be performed on a quality schedule and in special circumstances.
Thermocouples can be used in some cases but often it is easier to use battery powered remote loggers. In both cases TQSoft™ thermal validation software can be used to calibrate before a mapping test, and calibration check during or at the end of the mapping process using the Calibration and Calibration Check feature.
Three mapping tests are required, and if there is a discrepancy between tests another mapping must be performed.
Large areas require many more mapped points than small areas or chambers to a minimum of 12. TQSoft™ can handle 128 separate loggers in a single mapping. MadgeTech Loggers are used for this procedure and have a batch handling interface in TQSoft™ to greatly improve setup and download times.
Storage areas and very large chambers are sometimes sub-divided into smaller areas. TQSoft™ Mapping Features allow users to create smaller map files and then merge data to create the whole picture up to 128 channels.
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 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.
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.
Storage areas and very large chambers are sometimes sub-divided into smaller areas. TQSoft™ Mapping Features allow users…
存储区域验证
制药和食品行业产品加工的大多数阶段都指定了温度、压力和湿度的控制参数。因此，热图对于控制这些过程至关重要。
收集数据并分析冷点或热点。映射测试必须在空室和满载室上进行。大多数类型的室都需要这种处理，从培养箱、储存区和仓库到高压灭菌器、EtO 室、稳定室、隧道、干热灭菌器。在特殊情况下，必须按照质量计划进行测绘。
在某些情况下可以使用热电偶，但通常使用电池供电的远程记录仪更容易。在这两种情况下，TQSoft™ 热验证软件可用于在映射测试之前进行校准，并使用校准和校准检查功能在映射过程期间或结束时进行校准检查。
需要进行三次映射测试，如果测试之间存在差异，则必须执行另一次映射。
大区域比小区域或室需要更多的映射点，最少为 12 个。TQSoft™ 可以在一次映射中处理 128 个独立的记录仪。 MadgeTech 记录仪用于此过程，并在 TQSoft™ 中具有批处理界面，可大大缩短设置和下载时间。
存储区域和非常大的房间有时会被细分为更小的区域。 TQSoft™ 映射功能允许用户创建较小的映射文件，然后合并数据以创建最多 128 个通道的整个图片。
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。
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。
存储区域和非常大的房间有时会被细分为更小的区域。 TQSoft™ 映射功能 允许用户……
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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。
Storage Area Validation仓储库房温湿度验证
