Cleaning validation for production tools_Acceptance limit

Hello there,

I am preparing a cleaning validation protocol for production tools (inox scoop, inox tray,…). Suppose that our worst-case product is X. The production of X used 4 machine A, B, C, D plus with inox scoop.
In the previous validation, my ex-colleagues said that it’s no need to sampling for API residual test. He took 2 samples for cleaning agent residue and microbial tests.

  1. Do we need to sampling for API residue? Why do/don’t we need to do that?
  2. How can we establish acceptance limit for cleaning agent residue on the scoop?
  • To production equipment: my colleagues used 10ppm criteria and the acceptance limit of cleaning agent on A, B, C, D is 45mcg/100cm2
  • To inox scoop he used an empirically number 100mcg/100cm2
    It seems unreasonable because there are two limits on the ‘same’ surface.

Thank you for spending time reading my question. I am new here and I find this site is very helpful.

Best regards,