Abstract: A process and apparatus for the manufacture of sterile filtered blood clotting factore from fibrinogen with an enrichment of Factor I is provided. The process includes the step of extracting blood from at least one donor, manufacturing fibrinogen from the blood extracted in a known manner, dissolving the fibrinogen in a buffer, and effecting a sterile filtration of the buffer-dissolved fibrinogen by means of a static filtration device at a pressure of less than 0.5 atmospheres.

Abstract: 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.degree. 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.