In order to generate standardized conditions for the microbiological control of HPCs, the PEI recommended defined steps for validation that will lead to extensive validation as shown in this study, where a possible validation principle for the microbiological control of allogeneic SCPs is presented. Although it could be demonstrated that automated culture improves microbial safety of cellular products, the requirement for extensive validation studies needs to be considered.
Keywords: automated culture; cellular products; haematopoietic stem cells; microbiological control; sterility testing.
© 2014 International Society of Blood Transfusion.