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).
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.
Calibrating the QbD1200 TOC Analyzer The calibration of a TOC Analyzer is a crucial part of ensuring a quality measurement.
JP SDBS Validation The QbD1200 has a built in qualification routine, “SDBS”, which makes performing a JP 16 compliant validation convenient.

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).
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.
Calibrating the QbD1200 TOC Analyzer The calibration of a TOC Analyzer is a crucial part of ensuring a quality measurement.
JP SDBS Validation The QbD1200 has a built in qualification routine, “SDBS”, which makes performing a JP 16 compliant validation convenient.