Qualification of a Stomacher

Hi All,

Am in the process of qualifying a stomacher and just wondering what your take is on how to go about it. My initial thoughts were that it is simple in its operation as all it does is homogenise samples so as long as it does then thats ok so questioned whethre a PQ is needed as i couldn’t find any reference to one being done online. However i am now going down the route of completing a method validation so that the test sample result can be compared to the T0 count in order to determine if the amount inoculated onto the sample has been recovered after stomaching. What are your thoughts?

Thanks in advance