A process of preparing a double-sterilized immunoglobulin product for
intravenous injection includes dissolving Cohn's component II in distilled
ice water, and adjusting to the desired pH using acetic acid. A filter is
used to remove alcohol and salt and establish a desired sodium ion
concentration, and the immunoglobulin concentration is adjusted to form
interim product, which is bottled. The bottle is filled with gaseous
carbon dioxide to achieve a pressure of 0.7 to 200 kPa, sealed in the
absence of any protectant, and sterilized. The interim product is
filtered, concentrated to achieve an immunoglobulin concentration of 5% to
10%, adjusted to a desired pH, filtered to remove bacteria, and stored at
room temperature for 21 days. Glucose is added in order to change the
osmotic pressure equilibrium of said interim product to form final
product.