What are the tests performed for chemical swab sample and micro swab sample???
The tests to be performed on swab samples collected during cleaning validation are specified in the Cleaning validation protocol.
The chemical tests include quantitative determination of carry over residue(s) of previous product API, and impuritie(s), toxic compund(s), excipient(s) if any.
The microbiological tests include Total bacterial & fungal count and objectionable micro-organisms (pathogen if any).
These results are to be corelated with the ‘Acceptance criteria’ defined in the cleaning validation protocol.
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And what is the limit for rinse and which test is carried out for rinse.