Fresh Frozen Plasma is an important raw material for the production of coagulation factor concentrates for patients with hemorrhagic disorders. Since coagulation Factor VIII (FVIII:C) is the most labile hemostatic protein, the freezing process of plasma needs to be optimized for the best yield of Factor VIII.
This paper discusses the recommendations made by the existing medical and scientific literature concerning the freezing time of plasma along with Good Manufacturing Practices and the average freezing time of the Contact Shock Freezers developed by B Medical Systems.
Our Contact Shock Freezers have shown average freezing times of approximately 26 minutes when tested using 30 units (for CSF 61) and 48 units (for CSF 101) of 350ml bags. This is well within the permissible ranges preventing any substantial loss of Factor VIII in frozen plasma.