Qualification of a disinfectant is demonstrated through performance testing to show that the disinfectant can reduce the microbial bioburden found in a pharmaceutical manufacturing area. The primary tests are divided into suspension tests, surface tests and field trials. 

Of these phases, it is most common for a pharmaceutical end user to select surface testing methods for their validation assessment. Surface testing allows for robust assessment of how a disinfectant will perform specifically on materials found within the cleanroom facility.

EudraLex Volume 4 Annex 1 for manufacture of sterile medicinal products states:

‘The disinfection process should be validated. Validation studies should demonstrate the suitability and effectiveness of disinfectants in the specific manner in which they are used and on the type of surface material…’

Whilst it is very common for disinfectant validation to use coupon studies such as EN 13697 without mechanical action, it has become increasingly popular to incorporate wiping. Not only can wipe methods reflect the specific manner in which a disinfectant is used, they also allow for assessment of microbial efficacy of a wipe substrate and the biocidal chemistry combined.