Safety control of peripheral blood progenitor cell processing-eight year-survey of microbiological contamination and bag ruptures in a single institution.

ABSTRACT

BACKGROUND AND OBJECTIVES: 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. MATERIALS AND 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.