Water Release Testing for GMP Manufacturing

Water Release Testing Products

ANATEL PAT700

The ANATEL PAT700 is a total organic carbon analyzer for on-line release testing for Conductivity and TOC Analysis

QbD1200

 The QbD1200 is a total organic carbon analyzer for point-of-use grab sample analysis for TOC analysis

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Content and Resources

ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems This page discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document2 from the International Conference on Harmonisation.
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).
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.
JP SDBS Validation The QbD1200 has a built in qualification routine, “SDBS”, which makes performing a JP 16 compliant validation convenient.
Detection Limit For Detection Limit (DL), often referred to as Limit of Detection (LOD), both ICH and JP 16 offer clear direction.

Content and Resources

ICH Q2 – the Challenge of Measuring Total Organic Carbon in Modern Pharmaceutical Water Systems This page discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document2 from the International Conference on Harmonisation.
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).
Calibrating the QbD1200+ TOC Analyzer The calibration of a TOC Analyzer is a crucial part of ensuring a quality measurement.
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.
JP SDBS Validation The QbD1200 has a built in qualification routine, “SDBS”, which makes performing a JP 16 compliant validation convenient.