PAT700 TOC 분석기

PAT700 TOC 분석기는 정제수 및 주사용 증류수(WFI)의 전체 유기 탄소(TOC) 및 전도도에 대한 약전 요구사항을 만족하는지 확인 및 입증을 위해서 특수 설계되었습니다.

  • TOC, 전도도 및 온도를 동시측정 – USP<643> 및 USP<645>로 완전히 보정 및 검증될 수 있음
  • 저렴한 유지보수 비용 – 12개월 서비스 및 보정 간격
  • Root-Cause 분석 지원 – TOC 일탈이 있을 경우 물 시료 자동 채취
  • 모든 SOPs는 PAT700으로 화면상에 표시되어 단계적으로 안내하며 사용자가 쉽게 사용할수 있도록 설계

관련 문서 및 응용 분야 자료

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Clean-In-Place Processes and Total Organic Carbon Analyzers
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.
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.

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