title: Bacterial contamination of ex vivo processed PBPC products under clean room conditions.
abstract: BACKGROUND
  Patients undergoing high-dose radio- and/or chemotherapy and autologous or allogeneic PBPC transplantation are at high risk for infections owing to profound immunosuppression. In this study, the rate of microbial contamination of ex vivo processed PBPC products was analyzed, comparing preparation under clean room conditions to standard laboratory conditions.
  
  
  METHODS
  After implementation of good manufacturing practice conditions in the two participating institutions, the microbial contamination rate of 366 PBPC harvests from 198 patients was determined under certified clean room conditions (Group A) from 2000 until 2002. To investigate influence of improved environmental conditions along with other parameters, this set of samples was compared with a historical control set of 1413 PBPC products, which have been processed ex vivo under a clean bench in a regular laboratory room and were harvested from 626 patients (Group B) from 1989 until 2000.
  
  
  RESULTS
  In Group B microbial contamination was found in 74 PBPC products (5.2%) from 57 patients. In Group A microbial growth was detected in 3 leukapheresis products (0.8%) from 3 patients. After exclusion of PBPC products, which were probably contaminated before manipulation, statistical analysis showed a significant difference (chi2= 10.339; p < 0.001).
  
  
  CONCLUSIONS
  These data suggest an impact of clean room conditions on the bacterial contamination rate of PBPC products. To identify confounding variables, variables like technique of leukapheresis, culture methodology, and microbial colonization of central venous catheters were taken into account. Further variables might be identified in following studies.
authors: Department of Haematology, Oncology and Immunology, Philipps-University Hospital, Marburg, Germany. markus.ritter@mailer.uni-marburg.de
authors: Markus
authors: M
authors: Ritter
authors: Joachim
authors: J
authors: Schwedler
authors: Jörg
authors: J
authors: Beyer
authors: Kamran
authors: K
authors: Movassaghi
authors: Reinier
authors: R
authors: Mutters
authors: Andreas
authors: A
authors: Neubauer
authors: Nimrod
authors: N
authors: Schwella
mesh_terms: D001419:Bacteria / Q000302:isolation & purification*; D001431:Bacteriological Techniques; D001773:Blood Cells / Q000382:microbiology*; D002469:Cell Separation / Q000295:instrumentation; D004780:Environment, Controlled; D006801:Humans; D007937:Leukapheresis; D013234:Stem Cells / Q000382:microbiology*; D013997:Time Factors