Hi,
Just wondering if anybody could provide information on the standard swab area used for cleaning validation?
Looking for information to support the use of 5cm x5cm swab area…any articles/journals/white papers to support this would be really helpful.
Thanks,
SF
hi
as per industry norms 10X10 cm2 swab area
Honestly there is no magic number or hard rule for swab area. It can be between 25 square cm to about 100 centimeter square.
The key is consistency, and recovery studies should be done using the same surface area. For flat (or relatively flat) surfaces, there are several techniques to control the surface area swabbed. One is to use a template placed over the surface to be sampled. For example, chemically inert templates made of polytetrafluoroethylene (PTFE) , having a “picture frame” of 25-100 cm2, have been used. The template is held against the surface, and the defined surface is swabbed. An alternative is to train people so that they “know” what the defined surface area is.