CLEANING VALIDATION COUPONS

pharmaceutical manufacturing equipment

WHAT ARE THEY FOR?

A cleaning validation coupon is used in the laboratory to validate a proposed swabbing method

Example: if your proposed method for swabbing involves a solvent, say methanol, how do you know if that solvent and the swabbing technique you are going to use will actually recover the residue from the surface? In order to determine the efficiency of your swabbing method in recovering the residue, a cleaning validation coupon, matching the material of construction and the finish of the subject surface, is spiked with known amount of a solution of the residue of known concentration, dried, and swabbed with your proposed swabbing method and the swab analyzed for the residue. If the recovery of the residue is within acceptable limits, then you can proceed to do the swabbing on the subject surface.

COUPON TYPES

GlobePharma offers coupons made of several different materials with different finishes, such as 316 stainless steel, 304 stainless steel, aluminum, brass, bronze, a variety of plastics and rubbers, etc. Standard dimensions of the coupons are 1/8” x 2” x 2” and 1/8” x 4” x 4”. However, a custom-made cleaning validation coupon is also available.