USP<645> describes conductivity as key parameter for measuring the purity of ultrapure water and water for injection. Compliance with USP<645> is key for manufacturers from the pharmaceutical industry. However, following the three stage test procedure defined by the standard can be a challenge, particularly if the testing is performed manually. A dedicated Metrohm system provides a fully automated solution to this challenge reducing the risk of error while increasing productivity.
USP<645> describes a cascade of three tests, which have to be performed in sequence. If testing at stage one fails, the procedure defined for stage-two testing has to be performed, which in case of failure has to be followed by the stage-three testing. Failure at stage three equals an out of spec sample. The risk of human error is considerable at each stage, as thorough working is required and conditions must be met such as a maintaining a specific temperature in the solution.
The Metrohm system for conductivity testing according to USP<645> provides a fully automated solution to this challenge. All that is required from the operator is filling the sample into a beaker and placing it on the system’s autosampler. Conductivity testing in whole series of samples is then performed completely unattended while tiamo software makes sure data integrity is maintained and compliance with regulatory standards such as FDA 21 CFR Part 11 is met.