ANATEL PAT700 TOC Analyzer

Reliable TOC Monitoring for Pharmaceutical Water Systems

The ANATEL PAT700 Total Organic Carbon (TOC) Analyzer is engineered to support pharmaceutical manufacturing by ensuring accurate, compliant water quality testing. Ideal for Purified Water (PW) and Water for Injection (WFI) systems, and for Clean-In-Place processes, the PAT700 helps meet critical pharmacopeial standards including USP<643>, USP<645>, and EP 2.2.44

Key Features

  • 3-in-1 Measurement Measures TOC, Uncompensated Conductivity, and Temperature from a single analyzer.
  • Pharmacopeial Compliance Can be fully validated to meet USP <643> and EP2.2.44 requirements for TOC, and USP <645> for Conductivity.
  • Extended Service Intervals Requires calibration and servicing only once every 12 months.
  • Automated Sample Capture Automatically collects a water sample when a TOC excursion is detected for root-cause analysis.
  • Pre-Loaded SOPs with Visual Guidance Includes intuitive, step-by-step Standard Operating Procedures (SOPs) with on-screen pictures and prompts.

Benefits

  • Ensure Regulatory Compliance Maintain confidence in meeting global pharmacopeial requirements with validated performance.
  • Simplify Operations and Training Built-in SOPs reduce operator errors and accelerate onboarding of new users.
  • Minimize Downtime and Maintenance Costs Long calibration and service intervals lower the total cost of ownership.
  • Rapid Troubleshooting Immediate sample capture helps diagnose and resolve TOC anomalies quickly and effectively.
  • Compact, Integrated Solution Combines multiple measurements in one unit, saving space and simplifying system integration.


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Content and Resources

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Importance of TOC measurement in WFI in light of European Pharmacopoeia change This paper discusses the increased focus on Total Organic Carbon (TOC) and conductivity measurement, especially for companies seeking to use RO water treatment plants to create WFI, and provides best-practice advice for calibration.
European Pharmacopoeia EP 2.2.44 and Total Organic Carbon This paper discusses the background behind the European Pharmacopoeia&rsquo;s focus on complete oxidation of TOC in the light of the increased importance of on-line Total Organic Carbon (TOC) and conductivity measurement.
21 CFR 第 11 部分关于在线 WFI 仪器的数据完整性要求 本文探讨了在 WFI（注射用水）的质量控制环节，如何配置关键质量控制的在线总有机碳（TOC）和电导率分析仪，从而帮助客户满足 FDA 对数据完整性的要求，包括 Microsoft Active Directory（微软活动目录）控件的使用以及 PDF 数据的规范导出。
Validation of On-line Total Organic Carbon Analysers for Release Testing Using ICH Q2 This paper discusses how characteristics for consideration during the validation of analytical procedures may be applied to on-line Total Organic Carbon (TOC) analysers to enable them to be used to provide release test data for Water for Injection (WFI) and Purified Water (PW).
自动化生物制药质量控制以降低成本并提高数据完整性 本文研究了四种常见的质量控制程序，以及自动化如何通过减少人为错误的机会来帮助提高数据完整性，同时还节省了时间并降低了运营成本。

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