PT  - JOURNAL ARTICLE
AU  - Fulton, Beth
AU  - Welch, Angelica
TI  - A Risk-Based Approach for Managing Affinity Resin Contaminations
AID  - 10.5731/pdajpst.2022.012814
DP  - 2023 Sep 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 420--435
VI  - 77
IP  - 5
4099  - http://journal.pda.org/content/77/5/420.short
4100  - http://journal.pda.org/content/77/5/420.full
SO  - PDA J Pharm Sci Technol2023 Sep 01; 77
AB  - This commentary outlines a proposed approach for navigating remediation (non-routine sanitization) of contaminated affinity-based resins. The 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.