MAC value

Dear All,
This is the query for the formula what we use to arrive the MAC value.
We use the formula based on Largest Daily Dose [ldd]. (ie).
MAC [in mg] = SF x J x SBS x1000000 x U
SF=safety factor, since oral solid dosage we use 1/1000 [0.001]
J= Smallest strength of Product A mfgd in the equipment train [in mg]
SBS = Smallest batch size of any other product , which is mfgd using the same equip train [in Kg][Product B1]
1000000 = for conversion of Kg to mg.
LDD= Largest Daily dose of any other product , which is mfgd using the same equip train [Avg wt x no of daily doses](ie Product B2]
U= Swabbed surface area in 4 sq.inch
L= Shared equipment contact surface area between A& B in sq. inch.

My query is to which approach [either 10ppm or Dose criteria] the above formula fits.???
If not so, pls describe any other parameters which I’m missing out in the above mentioned formula.

With Regards,

Hi T. Arun !

Nice to see you on Askaboutvalidation.

The above mention formula is ok, with a littile bit correction of dilution factor [If Any], as well as Spike recovery % before finalizing the Swab Limit.

With respect to your query the formula is basically derived only for dose base criteria, as from formula it self you can see we are using Minimum stregnth & Maximum Daily Dose.

While we are in path of cleaning validation there are three criteria :

  1. Dose base [Well defined above]
  2. 10 ppm
  3. Visual Inspection

Happy Reading !