View Full Version : cleaning validation_microbiological Standards
08-18-2010, 12:56 PM
I would like to know the microbiological standards for surface cleaning validation. could you help me please!!!!!
09-10-2010, 05:27 AM
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.:)
09-10-2010, 05:45 PM
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
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