NADCAP Pyrometry Audit
AMS2750航空航天高温热处理测量
The standard demands adherence to rigorous thermal validation and reporting practices which are comparable to requirements, standards and procedures that have been current in areas such as autoclave validation for some time.
TQAero thermal validation software has a database of furnaces where class and type of instrumentation can be set.
TQAero thermal validation software has the ability to monitor usage time, number of uses, and maximum exposed temperature of each thermocouple. Under revision D furnaces with instrumentation types A & B will require load thermocouples whose usage limits will depend on maximum temperature.
The accuracy of the thermocouples and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice. The validation report must show that thermocouples, calibration and data acquisition equipment have been checked against a traceable standard when required.
Temperature Uniformity Survey (TUS) requirements are defined in terms of Furnace Class and Instrumentation Type. TUS’s must be carried out at the frequency required by AMS2750. Failure to do so will result in loads being recalled at great expense to the treatment company. Revision D has redefined the furnace classes and hence the frequency of TUS’s required.
System Accuracy Survey (SAT) requirements are also defined in terms of Furnace Class and Instrumentation Type.
TQAero contains all the data necessary to provide proof of compliance to AMS2750. All parameters and data in TQAero is audited and tamper proof to 21CFR Part 11 standards.
TQAero is fully configurable to alert users to TUS, SAT, thermocouple calibration and thermocouple replacement deadlines.
提供其遵守标准中规定的程序的证明。
该标准要求遵守严格的热验证和报告实践,这些实践与高压灭菌器验证等领域现行的要求、标准和程序相当。
TQAero 热验证软件有一个熔炉数据库,可以在其中设置仪器的类别和类型。
TQAero 热验证软件能够监控每个热电偶的使用时间、使用次数和最大暴露温度。根据版本 D,配备 A 型和 B 型仪表的熔炉将需要负载热电偶,其使用限制将取决于最高温度。
用于执行热验证的热电偶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。验证报告必须表明热电偶、校准和数据采集设备已根据需要根据可追溯标准进行了检查。
温度均匀性调查 (TUS) 要求是根据炉子等级和仪器类型定义的。 TUS 必须按照 AMS2750 要求的频率进行。如果不这样做,将导致处理公司付出巨大的代价来召回货物。修订版 D 重新定义了熔炉类别,从而重新定义了 TUS 所需的频率。
系统精度调查 (SAT) 要求也根据熔炉等级和仪器类型进行定义。
TQAero 包含提供 AMS2750 合规性证明所需的所有数据。 TQAero 中的所有参数和数据均经过审核并防篡改,符合 21CFR 第 11 部分标准。
TQAero 完全可配置,可提醒用户 TUS、SAT、热电偶校准和热电偶更换期限。
NADCAP Pyrometry Audit AMS2750航空航天高温热处理测量
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