RT Journal Article
SR Electronic
T1 A risk-based approach for managing affinity resin contaminations
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2022.012814
DO 10.5731/pdajpst.2022.012814
A1 Fulton, Beth
A1 Welch, Angelica
YR 2023
UL http://journal.pda.org/content/early/2023/07/14/pdajpst.2022.012814.abstract
AB This commentary outlines a proposed approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins. Methodology for collection of relevant information and for subsequent decision-making is presented, along with a tool for determining risk to the process associated with proposed return-to-use of remediated resin.