Dear all,

My query is in the Limit calculation based on dose criteria

As per the formula provided by Fourman, GL & Mullen MV, “Determining cleaning validation acceptance limits for Pharmaceutical Manufacturing operations”.Pharm Technology.17(4), 54-60, 1993

mg of active ingredient in contaminating product’A’ permitted per swabbed surface area = (I/J)*(K/L)*U
Where,
I = (1/1000* smallest strength of product A manufactured) expressed as mg/day & based on amount of active present in product’A’

J = Maximum number of dosage units of ProductB_1 taken /day

(Product_B1 is the product manufactured after product’A’,)

K = Number of dosage units per batch of ProductB_1

L= Shared equipment surface(in sq.inch) area in common between Product A & B_1/B_2

U= Swabbed surface area in sq.inch

My Query, is the Parameter ‘J’ this the Maximum Daily dose value or Dosage units??.

Consider the following example.

[Case.1]Product_X_B1, has posology of 10tablets /day, with average weight of 30mg/Tablet

[Case.2]Product_Y_B1, has posology of 1tablet /day, with average weight of 350mg/Tablet

If we assume that both Product_X_B1 and Product_Y_B1 , has same batch size in terms of KG.

which product , I should consider for worst case ‘J’.??