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Worst case selection for validation

How do I select the worst case product if all of my products are of same potency (500mg) and all are slightly soluble in water and I am using water as cleaning agent? You may suggest me to select the toxicity data. But what to do if I do not have the toxicity data of the active pharmaceutical ingredient?

youl probably need to carry out some proof of concept work on ‘coupons’ in the lab. different products may stick to the surfaces more etc. try spiking them on coupons and simulate the cleaning in the lab.?

Try referencing the LD50’s of the products using MSDS data, most common is ORL-Rat. Or reference products from similar groupings/categories (functional groups). Maybe use cleanability assessments of the products. If all products have identical strengths (from your post I can gather that the dosage is approx 500mg, so the products are not particularly potent) and similar solubilities; you can use a cleanability assessment of the final product based on operator experience to select your worst case.

Worsy case can also be find out based on…
1.solubiltiy in water…
2.train of equipment…
3.Least btach size of product taken in that particular tarin…

Regards

Prasad

Seems difficult to believe that all of your actives have exactly the same potency. Remember, the potency used for calculation is the minimum marketed dosage, so, don’t consider only the standard potency of your dosages, but go for differences in pediatric dosage forms, consider equivalent products from your competitor, etc. To compare solubilities try to find the numeric figures for solubility, not only the descriptive “slightly soluble”. As mentioned above, run mock cleanings of spiked coupons to detect the hardest to clean substance. If even after all this investigation all your target substances prove exactly equivalent, then… it makes the same to choose any of them.

Best regards

Alfred

Do the same actives have the same dosage rates especially in the paeditrics and do you use same process train?

Thank you very much for your answers. What I did is that I have taken the experimental and predictable solubility data for selecting the worst case.

In some suggestions i found the term as process train and equipment train. Can anybody suggests me what those terms mean. May be understanding of these terms may help me.

Thank you very much for your answers. What I did is that I have taken the experimental and predictable solubility data for selecting the worst case.

In some suggestions i found the term as process train and equipment train. Can anybody suggests me what those terms mean. May be understanding of these terms help me.