Hi,
I have a question about validation of the analytical methods used for microbiological testing of TAMC and TYMC. We perform tests both with contact plates and swab sampling for microbiological monitoring of equipment and facilities in our (non-sterile) production of tablets.
Does anyone have knowledge about if the microbiological tests need to be validated and what is included in the validation? Does one need to perform some sort of recovery tests for the sampling? How is this performed in that case?
Hi Stefan,
we should perform the recovery test by using standard organisms containing NMT 100 CFU/1ml.
For swab recovery we should innoculate the test specimen with standard culture containg NMT 100 cfu/0.1ml. Then swab the innoculated area. keep the swab in normal saline. Do the membrane filtration and incubate the plates.
For contact plates innoculate the test specimen with standard culture containg NMT 100 cfu/0.1ml apply the contact plate on innoculated area then incubate the plates. Recovery should be NLT 70%.