RT Journal Article SR Electronic T1 Quantifying and Assessing Cleaning and Disinfection Residues JF PDA Journal of Pharmaceutical Science and Technology JO PDA J Pharm Sci Technol FD Parenteral Drug Association (PDA) SP 767 OP 768 DO 10.5731/pdajpst.2024.99909 VO 78 IS 6 A1 Hoal, Madison A1 Duffy, Aoife YR 2024 UL http://journal.pda.org/content/78/6/767.abstract AB 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.