The good stability of the freeze-dried plasma has been confirmed by scientific studies. LyoPlas N - w is a therapeutically equivalent alternative to fresh frozen plasma (FFP).
Bux et al, Quality of freeze-dried (lyophilized) quarantined single-donor plasma.
Stability studies in accordance with ICH guideline Q1E
ICH Q1E, Evaluation of Stability Data, CPMP/ICH/420/02, August 2003
Loss of activity in selected plasma components
- During lyophilisate storage at refrigerated temperatures
- During lyophilisate storage at room temperature
The diagrams illustrate the activities of selected plasma components when stored at refrigerated temperatures and at room temperature, respectively. The mean values of 10 separate pools of blood groups A, AB and O are shown.
Stability tests outside the recommended storage temperature
- During inappropriate storage at elevated temperatures
The diagram illustrates the change in the fibrinogen concentration in LyoPlas N - w when stored at various temperatures. On days 3, 7, 13, 20 and 34, one bottle was reconstituted and its fibrinogen level tested (Clauss method). It is known from stability tests that fibrinogen is very sensitive to temperature. Up to a temperature of 27°C fibrinogen remains stable during the entire test period (34 days). At 38°C to 42°C the fibrinogen concentration decreases by approximately 22% (+/- 2%) of the initial concentration within 14 days. At elevated temperatures the loss of fibrinogen is distinctly higher. When stored at 70°C LyoPlas N - w proves insoluble within the first three days.
Stability tests after reconstitution
The diagram illustrates the activities of selected plasma components, in dissolved form, when stored at room temperature. Because the activity of protein S rapidly decreases at room temperature, it is advisable to transfuse the dissolved LyoPlas N - w within 6 hours of reconstitution.