PAT700 總有機碳分析儀

PAT700 總有機碳 （TOC） 分析儀,專為幫助驗證符合 TOC 的藥典要求以及純水和注射用水的電導率而設計。

  • TOC、無需電導率和溫度補償功能全集合於一台分析儀 - 可以完全校準和驗證符合 USP<643> 和 USP<645> 標準
  • 低購買成本 ——提供 12 個月服務和定期校準
  • Root-cause analysis support– 如果存在 TOC 異常，則自動採集水樣
  • 所有 SOPs 都預加載到 PAT700 中，提供螢幕圖片和提示逐步引導用戶使用儀器

文檔及應用短文

 

*本產品僅供工業與科研使用，不用於臨床診斷 


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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&rsquo;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.

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