I'm trying to perform ethylene oxide and ethylene chlorohydrin in the same method.The separation is good between EO and ECH.the system suitability is OK. but.When I plan recovery I met with the dilution and spike detection problem because of the product vairations. I have products 4000 ml volume and the product with 3,5 ml?
Hi Nur,
You might have to run the validation in different groupsets. Combine the 3.5mL as a group and the 4000mL as the other. My first guess would be the standard deviation as well as of course the mean for your larger device would be significantly different to your smaller device.
If this is still failing then you might consider using surrogates system (predictable behaviour) to validate your test method to show that sigma r&r is low through a low %sv (study variance) and then later do the testing per group and show that the gauge r&r is influenced because of part to part variation which is expected and not due to sigma r&r.
I hope this helps :)
Dushyant
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