Room sampling for cleaning validation

For cleaning validation, the method to be used for equipment can be validated using stainless steel plates and looking to the recovery rate on them. In order to validate the methodology to be used for a room, what can be used to validate the recovery rate on walls and floors of a room?
:slight_smile:

Dear Laura
The microbiological contamination of room can be validated by using the swab sampling, to swab the about 24 CM square of object by using the sterile swab sticks and then test the sample for total aerobic count,

Regards
R C Pantola

[quote=Laura]For cleaning validation, the method to be used for equipment can be validated using stainless steel plates and looking to the recovery rate on them. In order to validate the methodology to be used for a room, what can be used to validate the recovery rate on walls and floors of a room?
:)[/quote]

Dear Laura,

as to my knowledge there is no regulatory requirement for cleaning validation on non product contact surfaces (other than a “visually clean” requirement), but there may be “inspectional overshoots” that could trigger a cleaning validation on walls and floors. The recovery test can be performed with pieces of the wall or floor material, which in production areas may be a vinyl covering, epoxy coating or similar. What is below does not really matter (drywall, masonry, etc), except for influencing the roughness of the final coating. Most probably the engineering or maintenance department can get you samples, and then the recovery test is carried out as with stainless steel coupons. I think the real callenge is how to set acceptance criteria, without any model of how the contamination present on the wall would get into the product.

Best regards

Alfred