Equipment and Processing Report-07-20-2011

Even though manufacturers are responsible for ensuring the quality of combination products, some companies may not be certain about what quality system to apply to their production.

The author describes the components that make up a clean-in-place system and how the system should be built to ensure efficiency.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the July 2011 edition from BETE Fog Nozzle and Continental Disc.

We?re attempting to validate a clean-in-place process using total organic carbon (TOC) as the analytical method. Our swab-sample recovery tests are giving us inconsistent results. Recovery values range from 95% to 205%, and there seems to be no correlation with the amount of drug product deposited on the coupon. What could be the problem?