Is it necessary to perform swab testing in Non sterile API as part of Environmental monitoring? Can u tell me the guidelines which are supporting this type of Environmental monitoring by swab testing.
Swab testing is not required in non-sterile manufacturing.
But how if the machine was used in different drug categorization example cephalosphorin machine will be used for penicillin products. Can we perform swab testing as our reference?
That was for environmental monitoring. The swab testing is required for cleaning validation.
Dear Ankur sahab… Settle plate Method , Swab Test and Particle Count Test is performed for non-sterile area, particle count also performd each of 6 month. And other tests are performed monthly base. Thanks. Microbiologist Saleemullah at Unison Chemical Works
Swab test is performed for EM not related to products. U can perform this test each of the month at fixed date.
Rinse test could be performed.
Sample of water after washing/ cleaning before the start of next product could be performed so that it could be confirmed there are no traces of previous product…