Riboflavin is typically used in the OQ to demonstrate that the washing cycle covers the entire surface area of the parts washer. The PQ should demonstrate that the washing cycle is effective in removing Endotoxins, API, and particulates.
Finally the ‘Process Validation Protocol (PV)’ will use the drug product and its acceptance criteria.
Vials (ampoules) won’t be expected to have contact with any API at this stage. This is the washer to clean the vials prior to filling stage.
I’m trying to do the cleaning validation which will serve also as PQ of the equipment.
The thing is, i have read that the chemical decontamination test is usually done with sodium chloride. Is it acceptable to perform it with riboflavine? I won’t be able to quantify the riboflavine, but the absence of fluorescence isn’t enough to prove the decontamination?
Based on my experience and recent FDA and EU inspection the expectation is that you do SUB-visible particulate, visible particulate, riboflavin, Chloride. Sulfur testing should be done if the vendor does not provide documentation of sulfur free.
SUB-visible particulate - Check
Visible particulate - Check
Sulfur - Will check this. Can you provide any reference for this?
Riboflavin and Chloride - Do you have any explanation why do we need both tests if both substances are water soluble?