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New TOC Analyzers for the Pharma Industry Simplify Cleaning Validation and Total Protein Determination
The TOC (total organic carbon) analyzers of the multi N/C pharma series from Analytik Jena are being expanded. With the multi N/C 2100S pharma and 3100 pharma, two new device models are being introduced. Both systems are aligned even more closely with the requirements of the pharmaceutical industry.
The multi N/C 2100S pharma specializes in vaccine quality control using the measurement of total nitrogen. Thanks to the direct injection of samples, the system enables the fully automated and carryover-free processing of total protein analyses. With this TN analyzer, the quality control of vaccines can be achieved in a more time- and cost-effective manner. By contrast, the sister model multi N/C 3100 pharma is a fully automated high-throughput analyzer, which primarily performs TOC cleaning validation and the determination of extractable organic compounds (leachables) from polymer packaging in the pharmaceutical area.
Depending on the pharmacopoeias, the TOC/TN cleaning validation and TOC ultra-pure water test (i.e., WFI) can be carried out by means of high temperature combustion or wet chemical UV digestion. With the established multi N/C pharma UV and the new multi N/C 3100 pharma, customers now have a solution with a high degree of comfort in automation for both methods in the portfolio of Analytik Jena.
All systems of the multi N/C pharma series are equipped with new, completely FDA-compliant software that satisfies all the data integrity requirements of the pharmaceutical industry. The multi N/C 2100S pharma and the multi N/C 3100 pharma can be seamlessly integrated with the already existing models multi N/C pharma HT for the analysis of TOC traces with high temperature combustion and the multi N/C pharma UV for the detection of traces and ultra-traces with wet chemical UV digestion.