Condutivímetro de bancada TOC 2500 21 CFR PART 11 (LAB USE)

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Developed to meet the needs of laboratories that follow FDA 21 CFR Part 11 requirements, Gehaka TOC 2500 Total Organic Carbon Analyzer enables the rapid and accurate determination of total organic carbon (TOC) in purified water (PW), ultrapure water (UPW), and water for injection (WFI); being designed for benchtop laboratory use.

Equipped with ultraviolet (UV, 185 nm) photocatalytic oxidation technology and conductometric detection, the TOC 2500 eliminates the need for chemical reagents—both for analysis and sample preparation—allowing for direct measurements. Its operation is simple and intuitive, managed via touchscreen interface, and it includes an integrated printer.

The instrument features data security and traceability functions to assist in compliance with FDA 21 CFR Part 11 requirements which include individual electronic signatures, hierarchical access levels, and the logging of critical operations, with the ability to generate event reports (*Audit Trail).

Video de demonstração do TOC 2500 21 CFR PART 11 (LAB USE)

Características

  • Regulatory Compliance: Strictly meets the requirements of FDA 21 CFR Part 11, ensuring the traceability and security of generated data.

  • Intuitive Interface: Simplified operation through a touchscreen display and integrated printer, facilitating the acquisition and interpretation of results.

  • LAB-G Connection Software: Enables data export to a computer in various formats (PDF, Excel, JSON), as well as report generation and audit trail tracking.

  • Nationwide Technical Support: With technical assistance available throughout Brazil, we ensure the proper functioning of the equipment.

Benefits:

  • Validation-Ready Records: Ideal for pharmaceutical industries that require systems capable of validation for their processes.

  • Ease of Use: Simplified operation through an intuitive Human-Machine Interface (HMI).

  • Accuracy and Reliability: Consistent results in compliance with the highest industry standards.

Gehaka's TOC 2500 Analyzer represents the latest advancement in TOC analysis technology, ensuring excellence and reliability for your laboratory or pharmaceutical industry.


Especificação técnica

Alarmes Yes – High Conductivity – High TOC – Online Records
Alimentação Dual Voltage 110/220 VAC / 60 Hz
Condutividade From 0.05 to 10.00 µS/cm
Dimensões externas (L x A x P) 100 × 220 × 400 mm
Display Color Graphic Touchscreen Display
Documentação Complete IQ/OQ/PQ Protocols – in Portuguese
Entrega técnica Yes; Training, Installation, and Validation.
Precisão RSD < 2.5% at 500 ppb (< 2.5% at 0.5 ppm)
Relatório de eventos Yes – Audit Trail
Resolução 0.1 ppb (0.0001 ppm)
Temperatura From 12 to 45 °C
Tempo de análise < 5 minutes
Volume da amostra 50 ml

TOC 2500 21 CFR PART 11 (LAB USE)
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