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What is Hold Time Study for 70% IPA Protocol about?

This document outlines a hold time study protocol to establish the maximum hold time for 70% isopropyl alcohol (IPA) after filtration and storage. The study will involve filtering the 70% IPA solution and testing bioburden levels at various time points over 96 hours to determine if bacterial growth exceeds acceptable limits. If growth remains within specified criteria, the hold time will be established. The validation team will conduct the study according to the defined protocol, procedures, acceptance crit

Author

Ashok Lenka

Language

EN