Pharmacopeia Calibration Requirements

The United States Pharmacopeia (USP), European Pharmacopeia (EP) and all other pharmacopeias set strict guidelines for water quality and test equipment used in pharmaceutical manufacturing.

Conductivity is one of the most effective methods of detecting ionic contamination and ensuring water quality in a pharmaceutical water system. As a result, the ability to accurately detect low levels of ionic contamination is critical for consistent production of pharmaceutical waters.

Therefore, conductivity instruments must have the ability to accurately and repeatedly detect very small changes in conductivity. Periodic calibration of conductivity sensors is vital to measurement accuracy and is required by global pharmacopeias.

As detailed in this application note, METTLER TOLEDO Thornton’s UniCond™ Calibrator allows complete and convenient calibration of the meter/transmitter and the sensor in compliance with pharmacopeia regulations.

The Calibrator is used alongside the M300 ISM or M800 ISM transmitters and UniCond conductivity sensors, and is the only digital system available that meets pharmacopeia calibration standards. The Calibrator incorporates a convenient dial to select NIST-traceable resistances for all ranges of the UniCond’s measuring circuit.

This convenient calibration accessory permits in-line calibration without disturbing the integrity of the water system. The UniCond Calibrator uses NIST-traceable precision resistors to verify the performance of the system’s temperature and conductivity circuitry and exceeds the required accuracy of ±0.1μS/cm.

Topics covered in the application note are: