A validation study of starting use of new freezing bags in cord blood bank / 国际检验医学杂志

ABSTRACT

Objective To verify whether the storage bag can reach the use requirement of cord blood freezing storage by conduc-ting a series of tests before staring use of new type cryopreservation bag for cord blood.Methods According to the standard opera-tion procedure,28 new type cryopreservation bags were extracted.The cord blood units were performed the cryostorage and thaw for rewarming according to the standard operating procedures.Then the physical integrity and various quality indicators of cord blood in bag were detected,including the nucleated cell viability,cell recovery rate,CD34-positive cell,colony-forming cultivation of stem cells,sterility test and verification of actual load volume.Results All the tested storage bags passed the integrity test,and the various testing indicators of the preserved cells conformed to the use requirements.Conclusion The new type storage bag has the same performance and effect to original bag,it is verified that the maximum loading volume of 50 mL(for 50 mL specification of storage bag)and 80mL(for 250mL specification of storage bag)is safe.