I currently use 0.001-dose limit for cleaning validation. Suppose that the worst-case product is A and the following product is B. In the calculation of MACO, what is the ‘product contact surface’ (TSF)? Is that the product contact surface of equipment used in the production of A? Or contact surface of both A & B?
In case of following product is unknown, TSF is the total product contact surface of all equipment used in the factory?