Post Media fill cleaning verification

Quality Control
1

As a general practice after each product change over post cleaning we have to send the Rinse or swab sample to analyse the traces of API.(if cleaning validation is not being performed).

Hence after media fill post cleaning we have to send swab/rinse sample for analysis to verify the cleaning effectiveness.
But most of the organization does not have any specific developed method to trace out the residue quantity of media after post cleaning process, they just verify through GPT test or by meeting the WFI specification criteria. But these process will not confirm the quantity of media traces left after cleaning which are suppose to contaminate my next product on that particular line.
So, if anyone is having any specification/guideline/ method/thought process then please share for the better compliance.

1 Like
2

UV Method: The allowable residual should not be more than 10ppm of TSB standard solution at absorbance 200 to 500nm

Thanks

1 Like
3

Thanks for your support.
Are you trying to say that we have to prepare the standard of Tryptic soy broth.
And if we use SCDM at the time of media fill then we should prepare the standard of SCDM.
Am I right in this way???

4

Yes, it can be