Bioburden Validation Method For the "Before Filtration" and "After Filtration" Samples?

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 :slight_smile: , 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.

Don’t make any change in method during validation. Bioburden test doesn’t require to validate for all microorganisms, validate it with bacillus subtitles. Validation of MLT requires to use all microorganisms including pathogens. Bioburden doesn’t require to test for bacteria and fungus separately.