Effect of X-ray radiation exposure on lyophilized recombinant activated factor VII (formulated for storage at room temperature).

Objective: To investigate effects of air transport and X-ray radiation exposure through airport security of a new room temperature-stable rFVIIa formulation (NovoSeven/NovoSeven RT, Novo Nordisk A/S, Bagsvaerd, Denmark) lyophilized using in vitro study methodology, thus evaluating possible effects of exposure through airport security and airplane travel.

Research Design And Methods: The effect of X-ray radiation exposure of rFVIIa and the solvent histidine at two different doses (400 microSv and 2000 microSv) was examined immediately after exposure, and post-exposure after storage at 30 degrees C for 1 month. References samples, not exposed to X-ray radiation, were used for comparison.

Main Outcome Measure: Stability of rFVIIa after X-ray radiation exposure.

Results: All product parameters analyzed were within the acceptance criteria as well as within shelf life specification limits for the selected parameters for each product.

Conclusion: The product rFVIIa and solvent histidine are therefore not expected to be affected as a consequence of airplane traveling and X-ray exposure during airport security check using hand luggage scanners.