SIMPLIFIED WATER TESTING AND CLEANING VALIDATION Sievers TOC Analyzers When it comes to efficiency and compliance in pharmaceutical water testing and cleaning validation, Sievers products and solutions offer unmatched productivity and peace of mind. Whether in the lab, at-line, or online, Sievers products can be used to simplify testing and lean out processes, all while complying with the latest data integrity guidelines. SUEZ, through its Sievers product line of TOC Analyzers and solutions, is leading the way toward the future state of water testing. How does SUEZ provide expertise to the pharmaceutical industry with its Sievers instruments? Through its Sievers TOC Analyzers, SUEZ provides superior technology, design, quality, and service to the pharmaceutical industry. Whether in the QC lab, production, R&D, or engineering facilities, Sievers Analyzers can be deployed to meet compliance and lean out processes. With a history of excellence in the pharmaceutical industry, Sievers product experts are available to help customers develop methods, determine feasibility, and implement new applications as needed. Sievers also provides Validation Support Packages for qualification (both instrument and software), Real-Time Testing (RTT), and cleaning validation. These packages help
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ISSUE 35 - 2019
customers navigate the validation process and enable more efficient implementation. Sievers instrument health and failure analysis reports help efficiently close out any TOC Out-of-Specification (OOS) investigations. With complete traceability of Sievers reference materials, vials, and analytical instruments, the services and corresponding documentation SUEZ provides to close out non-conformances are unmatched in the industry. Beyond analytical instrumentation, Sievers certified services, consumables, and specialized support offer customers a complete TOC solution. From validation support and application expertise, to certified reference materials, failure analysis reports, and on-site services, SUEZ has the pharmaceutical industry covered to ensure customer success. How do your analytical instruments keep pace with changing demands and regulations in the industry related to RTT, faster analysis, or automation? With customers' limited time and resources, it is not enough to simply manufacture instruments that don't provide added value. The industry demands not only tools that are accurate, but also those that exceed compliance requirements and will help increase productivity, automate processes, and troubleshoot effectively. Starting with online monitoring and RTT of pharmaceutical waters, Sievers instruments enable better process understanding to perform corrective actions in real time and ensure quality. In alignment with industry guidance ASTM E2656, analytical instrument validation is required for real-time release testing. This can be achieved only with an analyzer, such as the Sievers 500 RL On-Line TOC Analyzer. The Sievers 500 delivers high quality online results, consistent with regulatory requirements for both process control and RTT. The robust Sievers 500 performance ensures the regulatory expectations can be met that are outlined in the FDA Process Validation Guidance document; ASTM E2656; and the ICH Q8, Q9, and Q10 international guidance. Also, WHO GMP Annex 2 Technical Report Series 970 encourages online TOC and conductivity monitoring. When it comes to faster analysis, Turbo mode for Sievers M9 Analyzers enables real-time profiling of TOC for water testing, troubleshooting, or cleaning validation. Available for online, grab, or lab samples with an autosampler, Sievers Turbo mode