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Global pharmaceutical companies often harmonize production around USP's strict requirements. This white paper discusses the key considerations to assess your conductivity measurement points to ensure they are in compliance with USP <644> and USP <645>.
It covers the key questions to ask when selecting a conductivity sensor including:
- How should my conductivity system be calibrated?
- Is my sensor for final quality or process control?
- What is the required accuracy of my sensor?
Therefore, global pharmacopeias like EP, JP, ChP and IP have continued to harmonize with USP. This white paper outlines the conductivity measurement requirements for pharmaceutical waters in two monographs: USP <645> and USP <644> (with <1644>). Moreover, the white paper answers five questions that can assist you in ensuring you are meeting USP <644> and USP <645>.
- How should my conductivity system be calibrated to meet pharmacopeia requirements for Purified Water and Water for Injection?
- What is the required accuracy for my conductivity sensor?
- Is my sensor monitoring final quality or is it part of process control?
- How must conductivity be reported for this compendial measurement point?
- Do my verification and calibration procedures need to match those set forth in the applicable chapter(s)?
METTLER TOLEDO conductivity sensors, transmitters and calibrators can help you meet all USP requirements for performance, reporting and in-line verification and calibration. The UniCond® conductivity sensors exceed the accuracy requirements of ± 2% and 0.1 μS/cm respectively, as outlined by global pharmacopeias. The transmitters display both compensated conductivity, non-temperature compensated conductivity and temperature readings from the same conductivity system, thereby eliminating the need for multiple sensors at the reporting point.
Read more about the UniCond conductivity sensors and transmitters by visiting:
- UniCond Conductivity Sensors – Accurate conductivity and resistivity for pharmaceutical waters.
- Transmitters – High performance analytical transmitters for fast and accurate process control.
