Cleanroom and production room Cleaning Validation

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi,

I was assigned to run validation for our production rooms (shared facilities), to determine the efficiency of our routine cleaning procedures.
We are using contact plate and settle plate methods. We take samples before and after sanitization.
but, do we need to undertake worst case scenario? and what aspects that should be considered if we need to? do we need to perform tests for residues of cleaning agent?

Thanks in advance.
Anis

2

Yes, you should consider worst case scenario where factors such as sampling points, sample number based on room size etc should be taken into consideration. You will have to consider performing a residue test in the cleaning validatino execution for equipment, which has direct contact with the product. Otherwise, I don’t think you are required to perform any. [quote=Anis]Hi,

I was assigned to run validation for our production rooms (shared facilities), to determine the efficiency of our routine cleaning procedures.
We are using contact plate and settle plate methods. We take samples before and after sanitization.
but, do we need to undertake worst case scenario? and what aspects that should be considered if we need to? do we need to perform tests for residues of cleaning agent?

Thanks in advance.
Anis[/quote]

3

For further reference & detail let see WHO Technical Report Series, No. 961, 2011, (3) sanitation.
regards
ML

4

[quote=Luqmanikram]For further reference & detail let see WHO Technical Report Series, No. 961, 2011, (3) sanitation.
regards
ML[/quote]

noted,
thank you for the answers,
Mr. tangkakj and Mr. Luqmanikram
but then, the problem is; our company isn’t a large one, with 24/7 production, we have 2 days rest when everything is turned off (including AHU), so, should we perform a study for hold times of clean for the production rooms (using contact plate, settle plate and airborne methods)? and can it (the study) be count as a worst case?

thank you.