November 16, 2022

What is That Residue?

Cleaning-Validation-Summit-2022 cropped_Page_1.png

Attending PharmaEd Resources Cleaning Validation Summit in San Diego in December? Don't miss CPG President Stephen Spiegelberg's talk on December 1 at 3:35 p.m. "What Is That Residue? When Visual Assessment and TOC Is Not Enough in Cleaning Testing."

Cleaning Operations Root Cause Analysis

Cleaning validation activities often involve nonspecific qualitative and quantitative assessment of residues using total organic carbon, weighing of residue, and visual assessment. In most cases, these levels of analysis are sufficient to establish consistency in cleaning operations. When cleaning operations drift out of control, or a downstream failure occurs, specificity in residue identification and quantitation is sometimes needed to determine the source of the issue. In this presentation, case studies of cleaning operations that required additional analysis are presented, with analytical techniques selected to help identify issues with cleaning operations as part of a root cause investigation.

Cleaning Validation Summit 2022, San Diego

Today’s regulators expect comprehensive risk assessments of your organization’s cleaning validation protocols. Attend Pharma Ed’s Cleaning Validation Summit at the Marriott San Diego Mission Valley on Dec 1-2 to learn best practices from leading industry experts and help you meet regulatory requirements.