Help required with basics on swab test with spectrohotometer

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

We are trying to start swab test in our pharmaceutical industry.
Can you please help with the estimation for example paracetamol after cleaning machines?
How do we prepare the standard solution of paracetamol (dilutions) and compare if we set the limit as 10ppm?
What will be the amount of solvent for swab?
What will be the overall calculation after taking aborbance with spectrophotometer?

Thanks

2

Hi Ashishshrestha

  1. You can try start about Cleaning Validation in PIC/S guidlines, WHO TRS937…ect but I think this paper is good for begining to swab Development

" Method development of swab sampling for cleaning validation of a residual Active Pharmaceutical Ingredient" ,Peiyang ( free Download))

  1. Before you are study about Method development of swab sampling. Do you have Analytical Method Validation of Paracetamol at Concentration range that your limit?

  2. I think Spectrophotometer is not suitable for cleaning validation range because the Insrument is Low sensivity and not selectivity.

                                                                       Best Regard
                                                                           Thanee
3

Absorbacnce of test (swab with 10 ml of solvent)/absorbance of std xconc of standard for determination of 10 ppm limit by spectrophotometer?
Spectrophotometer is thed only option for us.