We make a product which is 90% ethanol with a dissolved API on a campaign basis. The mixing vessel is cleaned, and the final step is rinsing with ethanol. Do we have to perform microbiological testing of the surface of the mixing vessel?
Why? Do you have a micro specification for your final product? If so how are you going to calculate the acceptance and whether the bugs are objectionable?
We do not have a micro-specification on the final product, given the high alcohol we did not think it necessary. Are you suggesting, that in this instance, we do not have to do any micro testing of as part of the cleaning validation.
Yes, no micro is required. However, you can perform TOC analysis based on the acceptance criteria calculation for Ethanol.
thanks