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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Importancia de la medición del COT en el API (agua para inyección) a la luz del cambio de la Farmacopea Europea Este documento analiza el mayor enfoque en la medici&oacute;n del carbono org&aacute;nico total (COT) y la conductividad, especialmente para empresas que buscan utilizar plantas de tratamiento de agua por &oacute;smosis inversa (RO) para crear API (agua para inyecci&oacute;n), y brinda asesoramiento sobre las mejores pr&aacute;cticas para efectuar la calibraci&oacute;n.
Farmacopea europea EP 2.2.44 y carbono orgánico total Este documento trata sobre los antecedentes que hay detr&aacute;s de la concentraci&oacute;n de la Farmacopea Europea en la oxidaci&oacute;n completa de COT en vista de la mayor importancia de la medici&oacute;n en l&iacute;nea de la conductividad en el carbono org&aacute;nico total (COT).
21 CFR Part 11 Data Integrity for On-line WFI Instruments This application note takes a look at how quality-critical on-line Total Organic Carbon (TOC) and conductivity instrumentation for WFI (water for injection) quality control can be configured to help companies comply with the FDA&rsquo;s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.
Validación de los analizadores de carbono orgánico total en línea para pruebas de liberación utilizando ICH Q2 Este documento examina c&oacute;mo podr&iacute;an aplicarse las caracter&iacute;sticas a tener en cuenta durante la validaci&oacute;n de los procedimientos anal&iacute;ticos en los analizadores de carbono org&aacute;nico total (COT) en l&iacute;nea, a fin de que se puedan utilizar para proporcionar datos de pruebas de liberaci&oacute;n de agua para inyecci&oacute;n (API) y agua purificada (AP).

Documentos técnicos

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