Detectability Scale (TOC) Tool


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This Swab Limit Derived Detectability (TOC) Scale Tool is developed to apply scientific and risk-based approaches to cleaning validation outlined in ASTM E3106 – “Standard Guide for Science-based and Risk-based Cleaning Process Development and Validation”. The Swab Limit Derived Detectability(TOC) Scale provides a framework to evaluate the suitability of Total Organic Carbon (TOC) analysis or any other analytical method for detecting the compound carryover in shared facilities. The framework emphasizes the principles of ICH Q9 for quality risk management, offering a more robust and transparent alternative to traditional risk priority number (RPN) methods used in failure modes and effects analyses (FMEAs). The detectability scale evaluates how close the TOC or any other analytical method Detection Limit (DL) is to the HBEL-derived swab limit for a compound by applying a logarithmic ratio of analytical method DL and swab limit. The resulting detectability score facilitate detectability visualization and prioritization in shared pharmaceutical facilities. The detectability scale complements toxicity and process capability scales to provide a holistic risk assessment framework. These tools collectively assess cleaning risks based on severity (toxicity scale), probability (process capability scale), and detectability (TOC detectability scale). The Swab Limit Derived Detectability (TOC) Scale Tool allows users to enter the necessary information and then calculate the detectability score and create visual comparison of Carbon Detection Index (CDI). The tool also allow user to generate the report incorporating visual and table which can then be added to the cleaning risk assessment report.

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