Safety control of peripheral blood progenitor cell processing-eight year-survey of microbiological contamination and bag ruptures in a single institution.
OBJECTIVE
Recipients of peripheral blood progenitor cells (PBPC) are prone to opportunistic infections and their lives depend upon the availability of PBPC. Centres responsible for PBPC processing are committed to provide patients with products which are as safe as possible. These must be processed under quality assurance requirements.


METHODS
A retrospective analysis of PBPC processed in a single centre according to quality assurance premises was carried out to define the rate and the cause of microbiologic contamination and bag ruptures.


RESULTS
940 microbiologic cultures were run on 725 cryopreserved bags. Five bacterial strains were identified in the positive cultures. The rate of bacterial contamination was 1.85% of the patients, 0.34% of the collected bags, and 0.79% of the reinfused bags. Bag ruptures occurred in 1.06% of the thawed bags.


CONCLUSIONS
Permanent quality control of peripheral progenitor cell processing is mandatory. Preventive measures such as ex vivo cell manipulation in a clean room facility and the use of a double-bagged technique are highly recommended to prevent bacterial contamination and to rescue progenitor cells in the case of a bag rupture if those cells are necessary for the haematopoietic reconstitution of a patient.
Mele
Lia
L
Blood Transfusion Service, Ospedale SS Antonio e Biagio, Alessandria, Italy.
Dallavalle
Franco Maria
FM
Verri
Maria Grazia
MG
Balza
Giuseppina
G
Allione
Bernardino
B
Salvi
Flavia
F
Levis
Alessandro
A
Caraccio
Valter
V
Borzini
Piero
P
D001419:Bacteria / Q000254:growth & development; D001793:Blood Preservation; D002469:Cell Separation / Q000379:methods; D015169:Colony Count, Microbial / Q000379:methods; D003257:Consumer Product Safety; D004340:Drug Contamination / Q000517:prevention & control; D006412:Hematopoietic Stem Cells / Q000382:microbiology; D006761:Hospitals; D006801:Humans; D011786:Quality Control