PT  - JOURNAL ARTICLE
AU  - Beth Fulton
AU  - Angelica Welch
TI  - A risk-based approach for managing affinity resin contaminations
AID  - 10.5731/pdajpst.2022.012814
DP  - 2023 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2022.012814
4099  - http://journal.pda.org/content/early/2023/07/14/pdajpst.2022.012814.short
4100  - http://journal.pda.org/content/early/2023/07/14/pdajpst.2022.012814.full
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.