Hello! Please make sure that the calculation. The product is a liquid dosage form. Sampling by rinsing. For the calculation of the МАСО take the following data:

BS - the minimum size of a series of subsequent product (active substance content in the following product) = 0.1 kg;

TD - the minimum therapeutic dose of the previous product = 45 mg/m2;

SF - safety factor = 1/1000;

LDD - the maximum daily therapeutic dose of the subsequent product = 100 mg/m2.

We carry out the calculation of the “10 ppm” in mg:

MACO = 10 x 10-6 (mg / kg) x BS (kg) that

MACO = 10 x 10-6 x BS = 10 x 10-6 x 0,1 = 1 mg

Us calculate “dose criterion”, in mg:

МАСО = TD х SF х BS / LDD, we obtain

МАСО = 45 х 1/1000 х 100000/100 = 45 mg

To validate the cleaning process of the reactor selected criterion of “10 ppm” with a minimum of MASO = 1 mg.

The maximum permissible concentration of residues in the sample is calculated using the formula:

СONC = МАСО x R x F / V, where

СONC - the maximum permissible concentration of residues in the sample in mg / ml.

R - recovery percentage (output) = 75.7%

F - concentration of the sample rate = 1

V - the volume of wash water = 500 ml, sample for lab = 100 ml

СONC = МАСО x R x F / V = 1 x 0,757 x 1/500 = 0.0015 mg / mL

Dear Lyubov

All your calculations are correct, except the following.

- Batch size (of next product) should be the quantity of drug product, not drug substance.
- TD & LDD: Why did you mention the dosage in mg / m2?
- Have you validated your test method at 1.5µ/ml concentration?

VEERRAJU

Good day, VEERRAJU !

Thanks for the reply!

- The drug is a liquid form, the size of the next series of 25 liters. How then do the calculation?
- The instructions for all drug doses are mg / m2 (mg / on the surface of the human body).
- Yes, the method validation.

if your batch size is in liter, you can either

- convert the TD and LDD values in volume (liters or ml) and apply in the MACO formula

or - convert the batch size into weigth (kg or mg) based on “weight per ml” of your batch