Lab Scale Rinse Recovery Study


I am performing a rinse recovery study and I wanted to see if any of you could share the general method you utilize for a lab scale study at your facility. I just wanted to see if the method we are developing is in line with the industry. We are utilizing stainless steel containers (representing the interior of process equipment) spiked with a known quantity of process soil. We then hold it for a dirty hold period and perform a simulated rinse utilizing a scaled down quantity of heated WFI (incorporating a safety factor for temperature). A stir bar and stir plate are utilized to simulate the sheeting action that occurs during a tank CIP. The rinse time is based on the average WFI rinse time that occurs in production (safety factor incorporated). The rinsate is then transferred to TOC vials and analyzed. I am also curious as to the percent recovery acceptance criterion that you utilize. It’s a simple study but I just wanted to check so see if it was similar to what has been performed at other companies out there. Thank you for any opinion or information that you could provide.