Thank you, Clifford, for your response. Question: We perform sterility cultures on plasma-lyte A reagent used in stem cell processing and cryopreservation upon opening reagent and at end of week after processing patients. This is mandatory by FACT regulatory guidelines. We alo use ACDA as a prophylactic anitcoagulant before cryopreserving stem cells to decrease the risk of product clotting upon thaw at time of transplant. Many pts./donors are sensitive to ACDA during apheresis collection of stem cells and require Ca++ gluconate administration which causes binding (clots) if additional ACDA is not added to stem cells. There is not criteria that I know of that requires sterility testing of anticoagulant reagent involved in stem cell processing. Does anyone else in hematopoietic progenitor cell processing labs encounter this? If so, what criteria are they adhering to, if any.