TOC analytical method in cleaning validations: criteria, limits and robustness of the process
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This study evaluates the performance of the Instran® online analyzer for continuous measurement of ammonium (NH₄⁺) over a three-month period without maintenance, recalibration, or reagent change. Through 717 analyses performed on a 5 ppm standard solution, it is shown that, despite the drift of the ion-selective electrode, the “known addition” technique developed by the system maintains exceptional accuracy (±0.3 mg/L). The results validate the reliability, repeatability and low maintenance requirements of the analyzer, positioning it as an efficient solution for long-term ammonium monitoring.