Detection of TOC and conductivity of alkaline cleaning agents using TOC measurement.
[Test Report] Simultaneous Measurement of TOC and Conductivity of Alkaline Cleaners Using Sievers M Series TOC Analyzer
In the pharmaceutical industry, cleaning validation of manufacturing equipment is a crucial element of quality control. In particular, accurately detecting residues of alkaline cleaning agents is essential for ensuring product safety and quality. Here, we will introduce a method for simultaneously measuring the TOC and conductivity of alkaline cleaning agents using the Sievers M9 TOC analyzer. - Characteristics and Importance of Alkaline Cleaning Agents We selected CIP-100Ⓡ as the alkaline cleaning agent commonly used for cleaning manufacturing equipment during product changeovers in the pharmaceutical industry. Its composition includes potassium hydroxide (10-30%) and disodium EDTA (1-5%), which contribute to its cleaning effectiveness. In cleaning validation, it is important to confirm that no cleaning agent remains on the equipment after the final rinse.
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- Measurement Methods for TOC and Conductivity CIP-100 was diluted to four concentrations (0.001%, 0.01%, 0.025%, 0.05%) and measured using the Sievers M9 model. - Results and Discussion Both TOC and conductivity showed very good linearity. It was reliably detectable even at the lowest concentration (0.001%). - Summary The Sievers M9 TOC analyzer can simultaneously measure both TOC and conductivity, which is helpful for detecting detergent residues during the cleaning validation process. CIP-100 is a common alkaline detergent, and the Sievers M9 allows for easy detection of trace concentrations through simultaneous measurement of TOC and conductivity. Please refer to the test report for more details.
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300_00296
Applications/Examples of results
Cleaning validation
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