I am conducting the cleaning validation of a Non-dedicated API line, where two products are being produced. Both products use the same cleaning procedure for every single installation. But due to the fact that different installations have different cleaning methods e.g. Reactors, centrifuges, compactoers etc etc, I bracketed the Line according to these cleaning procedures into eight separate cleaning validations.
My questions is this. I am now calculating the swabbing limits using MACO and MACOppm. The limit I am working with is: 10ppm of the following products batch size. Can i estimate a swab limit for each bracket by only considering the surface area of the equipment of that bracket e.g. Synthesis line surface area only? OR do I still have to take the cumulative surface area of the whole line?
Hope someone can help me :),