Cleaning validation_microbiological Standards

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

hello,

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

best regards,

ismahane.

2

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:

3

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

C= A-B/SF
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.

then

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

Thanks