Analisador TOC PAT700

O analisador TOC PAT700 cumpre totalmente com todos os requisitos de farmacopeias globais (USP, EP, JP). Cada amostra é totalmente oxidada garantindo o resultado mais preciso do TOC que segue as diretrizes EP2.2.44. O tempo de produção é garantido com o design da lâmpada de UV dupla principal e de reserva do PAT700, sendo a escolha ideal para a liberação on-line do TOC. Economize tempo e dinheiro - o PAT700 pode ser instalado on-line e executar até 4 amostras de captura off-line.
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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).
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.
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.

Documentos Técnicos

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