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ANNEXURE-II Cleaning validation of MEFENAMIC ACID IP

1. Introduction: Oxidisable Substances Check After Batch Manufacturing

The annexure provides a structured format for evaluating oxidisable substances after batch manufacturing as part of cleaning verification. It covers major product-contact equipment including the stirrer tank, sugar tank, manufacturing tank, transfer pump, storage tank, filter press, basket filter, homogeniser, and filling machine. Critical sampling locations include stirrers, lids, inner surfaces, bottom valves, inlets, outlets, filter plates, screens, filling nozzles, hoses, and silicone tubes. Results are recorded after the first and second batches to assess cleaning effectiveness, detect residual contamination, and provide documented evidence that equipment surfaces are adequately cleaned before subsequent manufacturing activities.

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