qualitygal

What about using some rare expired antisera? Would that be considered in the same way?

It is not a closed system--spike the plt and spike the saline. But I found nothing to have us do this--so we are going to stop doing the sterility check. Micro loves me.

I didn't think anyone would answer. it was worth a try. But I found what I needed to know, and there is no reason to do this as part of QC.

Does anyone use the COBE 2991 cell processor to wash apheresis platelets? My question is in regard to the equipment QC--should there be a sterility check? Cannot find information anywhere that this is needed. The washed product has 4 hour expiration; use the sterile kits(single use); use 1 Liter sterile saline bags(single use). Quarterly QC includes pre-/post- platelet counts and pre-/ post- protein level. Cannot find support for sterility check anywhere....but still looking.

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?

Recently we had an incident where the timer setting on the Irradiator was 6min 1sec, but the print out had 6min 2sec. The calculated time for the 27.5 Gy for central dose rate( the Radiation Officer adds 10% to minimum central dose of 25Gy) is 6min 1sec At the 25Gy dose it would be 5min 31sec. But, what would be the maximun acceptable Gy central dose for blood and blood products? (Cesium-137 source) Anyone have any similar problems or any suggestions?