VERFAHREN UND VORRICHTUNG ZUR HERSTELLUNG VON STERILFILTRIERTEN BLUTGERINNUNGSFAKTOREN.

摘要

A process for the manufacture of sterile filtered blood-clotting products includes the steps of extracting blood from at least one donor, physically separating the blood to obtain substantially purified plasma free of cellular components, deep freezing the purified plasma at a temperature below about minus 22 DEG C. to preserve Factor VIII, thawing the plasma to produce a cryo-precipitate, enriching the cryo-precipitate by physical treatment and physically separating the cryo-precipitate from the thawed plasma. The cryo-precipitate is then dissolved in a buffer and is sterile filtered by means of a static filtration with an autoclaved filtration device at a pressure difference of less than 0.5 atm. An apparatus for carrying out the process is also provided.