I’m looking at cleaning validation through coupon swabbing. My analyte is albumin and will be analyzed through a previously validated ELISA. I have a few questions regarding the process.
It seems that polyester swabs are the best for capture and release of analytes for cleaning validation. Does anyone have experience with them or knows of a better option?
Coupon treatment for recovery testing:
I see that typically a swab area of 10cm x 10cm or 5cm x 5cm is used for analyte recovery. Is the analyte deposited evenly on this area, left to dry, and then recovery swabbing performed? Or is the coupon normally submerged in a solution of known concentration, allowed to dry, and then swabbed? If the latter is the case, how does one determine the expected amount of analyte in the area?
It seems that 80% is the magic number for recovery by chemical analysis, and this number changes considerably for microbiological assays. Does anybody have experience with ELISA and expected recovery in this type of assay?
Thank you for your help,