Impact of manufacturing, irradiation and filtration steps to bacterial contamination of autologous fibrin sealant.
BACKGROUND
Preoperative production of autologous fibrin sealant has become a routine procedure during the last years. As a certain percentage of blood products is contaminated with bacteria, contamination of plasma used for the production of fibrin sealant cannot be excluded. Especially in the orthopaedic setting, application of contaminated fibrin sealant can cause severe infections.


METHODS
We contaminated plasma with Staphylococcus epidermidis, Corynebacterium striatum, Bacillus subtilis or Escherichia coli and produced fibrin sealant by cryoprecipitation and alcohol precipitation. Additionally, the products were gamma-irradiated at a dose of 30 Gy, frozen at -55 degrees C and filtered through a 0.2 microm filter after thawing. After each preparation step, samples were drawn and numbers of colony forming units were counted after incubation on agar plates.


RESULTS
Cryoprecipitation, irradiation, freezing at -55 degrees C, and alcohol precipitation have only little impact on numbers of colony forming units. Filtration through a bacterial filter results in a sterile product.


CONCLUSIONS
Bacteria in plasma as a starting material for production of fibrin sealant survive all routine steps of production, including gamma irradiation and freezing. Filtration of the product through a qualified bacterial filter is the only safe means to provide a sterile product.
Buchta
Christoph
C
Department for Blood Group Serology and Transfusion Medicine, Vienna Medical University, Vienna, Austria. christoph.buchta@meduniwien.ac.at
Dettke
Markus
M
Funovics
Philipp T
PT
Hirschl
Alexander M
AM
Macher
Maria
M
Worel
Nina
N
Höcker
Paul
P
D001419:Bacteria; D003257:Consumer Product Safety; D004340:Drug Contamination; D015718:Fibrin Tissue Adhesive; D005374:Filtration; D005720:Gamma Rays; D006801:Humans; D014182:Transplantation, Autologous; D014462:Ultrafiltration
D015718:Fibrin Tissue Adhesive