Total Organic Carbon (TOC) analysis is rapidly becoming the preferred alternative to HPLC, according to GE Analytical Instruments, for cleaning validation because of its accurate analysis, ease of use, and cost effectiveness. Readily accepted by the FDA, TOC provides a quantitative response specific for all organic compounds, and can quantify the organic levels in swab or rinse sampling.
The Sievers® 500 RL On-Line and the Sievers 900 Series TOC Analyzers from GE Analytical Instruments are the most sensitive TOC instruments on the market and ideal for cleaning validation applications. With the patented selective CO2 conductometric membrane detection, an autoreagent feature for complete oxidation, 21 CFR Part 11 compliance readiness, and operating ranges of 0.03 ppb to 50 ppm, the Sievers 500 RL and 900 Series TOC Analyzers offer an unsurpassed solution for removing cleaning validation constraints. Sievers TOC Analyzers can be used for Clean-in-Place rinse samples, swab recovery surface samples, and USP water releases without daily recalibration before running different levels of sample concentrations.
GE Analytical Instruments also offers a comprehensive guide on using TOC methodology in lab and on-line cleaning validation applications. The Sievers Cleaning Validation Support Package (CVSP), contains examples, worksheets, templates and sample protocols to significantly reduce the time and effort required to develop and complete cleaning validation protocols and procedures. To round out its cleaning validation offering, GE Analytical Instruments offers Sievers TOC Cleaning Validation Kits, which include 72 Certified (
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