Gammacell irradiator validation of canister contents

[qualitygal]

We validated our irradiator a while back, but in doing so we used different numbers of products per cycle as a way to show the FDA we have a set number in canister per cycle. However, we would like to up the number...but is it really necessary to "validate" because a quarterly dose mapping proves the entire area within the canister gets the necessary amount of irradiation. To me the dose map makes the case for however many you can get into the canister should be allowed...without validating.  My other question is does anyone use only one radsure label on one product-right now we place radsure on each product.

Does anyone have any recommendations or thoughts?

[ESIZENSKY]

We use a radsure label for each unit.