Hey guys ,
We got injectables (water soluable) and when i read the specifications on validation prosess, i saw that we have 10 cfu limit for 100ml (for the before filtration sample) and 0 cfu limit for 100ml (for the after filtration sample)
My question is do i have to validate the bioburden method?
If i have to (probably , i cant take sample more than 100ml. May i dilute the sample to 1/10 or 1/100, than perform validation? ( but the concentration of product is going to decrease)
Thanks for your advices.