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Table - Technique selection matrix in CleaningValidation

M
Markus Janssen

Example with scenarios and rationales on how to decide which method, or combination, fits which product and process

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Scenario Best-Fit Approach Rationale HPLC ELISA TOC / TN b Conductivity UV/Vis pH Bioburden Single API, well-defined risk + + + Compound-specific, low regulatory risk Multiple APIs, changeovers, unknown residue mix +1 + + Broad catch-all; supports fast changeover 1 Supported by specific method Strongly ionic cleaner + + + Direct measurement of ionic residue Routine/ongoing verification where products vary + + Minimal method dev, cost- effective High allergenicity/biological risk (e.g., proteins) + + + Necessary for biologicals’ specificity Visual/colored contaminant + + Fast, easy for chromophores Aseptic area, microbiological risk + + Detects live contaminants

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Table - Technique selection matrix in CleaningValidation

  • 1. Scenario Best-Fit Approach Rationale HPLC ELISA TOC / TN b Conductivity UV/Vis pH Bioburden Single API, well-defined risk + + + Compound-specific, low regulatory risk Multiple APIs, changeovers, unknown residue mix +1 + + Broad catch-all; supports fast changeover 1 Supported by specific method Strongly ionic cleaner + + + Direct measurement of ionic residue Routine/ongoing verification where products vary + + Minimal method dev, cost- effective High allergenicity/biological risk (e.g., proteins) + + + Necessary for biologicals’ specificity Visual/colored contaminant + + Fast, easy for chromophores Aseptic area, microbiological risk + + Detects live contaminants