I’m currently doing some cleaning validation in our primary packaging facility (pharmaceuticals) where active product is exposed. I understand that to quantify an acceptable level for API carryover that I need to calculate the permitted daily exposure limit and convert to a material residue limit. I’m having some trouble in understanding how I set a limit for detergent residue. We are using a pH neutral detergent so we can’t use conductivity, so we are thinking about using TOC. How do I go about setting an acceptable TOC limit?
[quote=Luqmanikram]Hi,
This guidelines will help you to set the Cleaning Validation limit.
Regards
M Luqman[/quote]
Thanks for that. Looking at section 4.2.3 I see that you can use ADE, based on LD50’s, to calculate carryover for detergents, however I am thinking of using a qualitative TOC method to show, hopefully, no presence of detergent. Do you think this is acceptable?
Hi all,
I think if in cleaning procedure we use solution from II class acceptable limit we can take from ICH Q3 (IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS). In this guideline we can use PDE data.