Analizzatore TOC PAT700

L’analizzatore di carbonio organico totale (TOC) PAT700 è perfettamente conforme a tutti i requisiti delle farmacopee globali (USP, EP, JP). Ogni campione è completamente ossidato per garantire la massima accuratezza del risultato TOC secondo le linee guida EP2.2.44. L’uptime di produzione è garantito dal design della doppia lampada UV di standby e principale di PAT700, che lo rendono la soluzione ideale per il rilascio di TOC online. Risparmia tempo e denaro: PAT700 può essere installato online e analizzare fino a 4 campioni prelevati offline.

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Clean-In-Place Processes and Total Organic Carbon Analyzers
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.
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).
Automating Biopharma Quality Control to Reduce Costs and Improve Data Integrity This paper takes a look at four common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst also saving time and reducing operating costs.
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’s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.

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