校准服务

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国际法规

  1.电导率校正需满足USP<645>(United States Pharmacopoeia)

  法规原文:Meter calibration is accomplished by replacing the conductivity cell with NIST traceable precision resistors (accurate to 0.1% of the stated value) to give a predicted instrument response. “Excluding cell accuracy, instrument accuracy must be 0.1 µS/cm”. Accuracy of the temperature measurement must be ± 2°.仪器的校准是通过使用可追溯至NIST(误差 0.1%)电阻来校准电导率仪,校准后的误差需控制在 0.1 µS/cm. 温度误差±2°C.

  解决方案:0.1% NIST traceable resistors Merck  kit available to check each scale of the meter part as requested. Merck  Field Calibration and Suitability Protocols require more stringent specifications.默克使用可追溯至NIST精度为0.1%的电阻器进行校准,提供的校准和适用性测试服务完全满足相关参数.

 

  法规原文:If the cell is changed/replaced for this specific application, calibration of the new cell is required. 如果新的电导率仪更换,需要重新校准

  解决方案:Merck  developed a Field Calibration Protocols. 默克提供专业校正及校正文本.

  法规原文:These different steps must be followed in this order to perform the USP <645> Test.整个校正服务必须遵循USP<645>性能测试

  解决方案:

  1.Merck  standard cell replaced by Merck USP cell (if performed for the first time).

  2.Calibration of the Merck  conductivity measuring instrument using the field Merck  field calibration protocol.

  3.Performance of the USP<645> test using the Merck USP<645> protocol.

  USP<645>使用的校正文本是基于默克提供的专业电导率校正服务及其文本.

  2.其它参考法规如EP,FDA,ISO3696,ASTM®等

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