Method of inactivating reproducible filterable pathogens in blood plasma products

• US 4,904,641 A
• Filed: 01/03/1989
• Issued: 02/27/1990
• Est. Priority Date: 01/12/1988
• Status: Expired due to Term

• Current Assignee: Immuno AG Fur Chemisch-Medizinische Produkte
• Original Assignee: Immuno AG Fur Chemisch-Medizinische Produkte
• Inventors: Philapitsch, Anton, Frechinger, Wolfgang, Elsinger, Fritz, Trambauer, Karl, Eibl, Johann, Dorner, Friedrich, Linnau, Yendra, Wober, Gunter, Schwarz, Otto
• Primary Examiner(s): Rosen, Sam
• Application Number:
  US07/293,085
• Time in Patent Office: 420 Days
• Field of Search: 424/101, 514/2, 514/7, 514/8
• US Class Current: 514/15.3
• CPC Class Codes: A61L 2/0023 Heat

Abstract

There is disclosed a method of inactivating reproducible filterable pathogens in blood plasma products by applying elevated temperatures. The blood plasma products are heat treated in a solid state in a closed inactivation container in the presence of specific amounts of water and organic compounds, provided that the water substantially remains physically bound to the blood plasma products, while the organic compound is present in a gaseous form in the atmosphere. The water content of the blood plasma products is 0.08 to 0.40. The concentration of the organic compounds in the gaseous phase is 0.01 to 10 g per liter of container volume.

Claims

1. A method of inactivating reproducible filterable pathogens in blood plasma products, wherein said blood plasma products are heat treated in solid state, which method comprises the combination of the following consecutive steps:

moistening the blood plasma products with water vapor under vacuum to adjust the blood plasma products to a water content of from 0.08 to 0.40 (8 to 40% by weight),

subsequently treating the thus obtained moistened blood plasma products, under vacuum, with an organic compound selected from the group consisting of ethanol, acetic acid ethyl ester, diethyl ether, dimethylformamide, toluene, chloroform, n-heptane, 1,2-diacetoxy ethane and acetone in a closed container, to attain a concentration of from 0.01 to 10 g of the organic compound per liter of container volume, and

heat treating the blood plasma products in the closed container at a temperature and for a period of time sufficient to inactivate the reproducible filterable pathogens,

the water remaining substantially physically bound to the blood plasma products, while the organic compounds stay in gaseous phase.

2. A method as set forth in claim 1, wherein said heat treatment is carried out in the presence of calcium ions.

3. A method as set forth in claim 1, wherein said heat treatment is carried out at a temperature of from 50°

to 80°

C.

4. A method of inactivating reproducible filterable pathogens in blood plasma products, wherein said blood plasma products are heat treated in solid state, which method comprises the combination of the following consecutive steps:

moistening the blood plasma products with water vapor under vacuum in a moistening container, to adjust the blood plasma products to a water content of from 0.08 to 0.40 (8 to 40% by weight),

equilibrating the thus moistened blood plasma products,

placing the equilibrated, moistened blood plasma products into an inactivation container,

subsequently introducing, under vacuum, into said inactivation container, an organic compound selected from the group consisting of ethanol, acetic acid ethyl ester, diethyl ether, dimethylformamide, toluene, chloroform, n-heptane, 1,2-diacetoxy ethane and acetone, to attain a concentration of from 0.01 to 10 g of the organic compound per liter of inactivation container volume, and

heat treating the blood plasma products in the inactivation container at a temperature and for a period of time sufficient to inactivate the reproducible filterable pathogens,

the water remaining substantially physically bound to the blood plasma products, while the organic compounds stay in gaseous phase.

5. A method of inactivating reproducible filterable pathogens in blood plasma products, wherein said blood plasma products are heat treated in solid state, which method comprises the combination of the following consecutive steps:

moistening the blood plasma products with water vapor under vacuum in a moistening container, to adjust the blood plasma products to a water content of from 0.08 to 0.40 (8 to 40% by weight),

equilibrating the thus moistened blood plasma products, placing the equilibrated, moistened blood plasma products into an inactivation container,

sweeping said inactivation container with dry nitrogen,

subsequently introducing, under vacuum, into said inactivation container, an organic compound selected from the group consisting of ethanol, acetic acid ethyl ester, diethyl ether, dimethylformamide, toluene, chloroform, n-heptane, 1,2-diacetoxy ethane and acetone, to attain a concentration of from 0.01 to 10 g of the organic compound per liter of inactivation container volume,

introducing dry nitrogen into the inactivation container to obtain ambient pressure therein, and

heat treating the blood plasma products in the inactivation container at a temperature and for a period of time sufficient to inactivate the reproducible filterable pathogens,

the water remaining substantially physically bound to the blood plasma products, while the organic compounds stay in gaseous phase.