Quantifying and Assessing Cleaning and Disinfection Residues

Madison Hoal; Aoife Duffy

doi:10.5731/pdajpst.2024.99909

Abstract

Joint presentation - Ecolab and HiTech Health (CDMO for CGT)

The purpose of this presentation is to review the impact cleaning and disinfectant residues can present to an ATMP cGMP manufacturing facility and discuss how to assess and manage these residues.

The term “disinfectant residue” can illicit different responses. For some, they pose a risk potential product contamination, or can alternatively be seen as evidence that cleaning and disinfection has been performed. For others it could be a sign of lack of control. With the most recent revision to Annex 1 there has been a renewed focus on control and removal of disinfection residues. This presentation will discuss how to minimize disinfectant residues by regime design and investigate the methodology associated to quantifying residues beyond subjective visual assessment.

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