Cleaning validation_microbiological Standards


I would like to know the microbiological standards for surface cleaning validation. could you help me please!!!

best regards,


Dear ismahane,
As per my knowledge, The monitoring of microbial load after cleaning is not that criticial if you are doing Steam Sterilization post cleaning. Provided your Sterilization is validated. I have till date not come across of monitoring microbial load with swab. If your final rinse during CIP is with WFI, I would recommend to check the final rinse sample to compare with WFI bioburden specificiation i.e. 10CFU/100ml.
I hope I have tried to clear your doubt.

Let me know if you need more.

All the best.:slight_smile:

Microbial limit for Non-sterile products shall be calculated based on the product specific requirement. you can use the following equation:

where SF= safety factor ( sholud be taken between 2 -5 for liquid orals & Topicals and betwee 10 -20 for Solid orals depending upon the product sensitivity)
A= Total allowable limit for subsequent product
B= Microbial load contributed in product which cleaned.


Limit per 4 s.q inch/swab= CX MBS X 4/ SA

MBS= Minimum batch size of next product
SA= total equipment surface area

Hope this helps