I have few doubt about the cleaning validation
as under guidance of the APIC we calculate the MACO but some how its show value is 2450000 mg . i.e 2.45 kg is to high.
We check so many time any calculation error we have done, but its show the same.
Our facility is dedicated facility we calculated base on LD50 (50-500mg) NOEL value and then MACO but its quite to difficult which one is corrected can you guys please help me for the solve the query.
Or for the calculating NOEL value we have two Range of the LD50 i.e 50-500 which one we select LD50 for calculating NOEL value
in current scenario the MACO calculation has been carried out by PDE value. Ld 50 is not acceptable, however if you want to calculate then below is the calculation
NOEAL = LD50*BW/2000, 50x70 (Standard body weight)/2000 (constant)
MACO = NOEL x batch size in mg (10 kg shall be written as 10000000)/ maximum daily dose of next product X SF (1000)
If the MACO is higher in the above calculation we can Use Acceptance criteria using a General Limit (APIC guidance document : GUIDANCE ON ASPECTS OF CLEANING VALIDATION IN ACTIVE PHARMACEUTICAL INGREDIENT PLANTS)
formula for calculating MACO=
MACO = MAXCONC x MBS
For formulation : 10 ppm is the limit = 10mg/kg
Your batch size : 200 Kg (example)
Then MACO= 10mg/kg x 200Kg
= 2000mg = 2000/1000 = 2 gm