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Process control methods for obtaining and maintaining a desired moisture content of spray dried plasma

Inactive Publication Date: 2016-03-24
VELICO MEDICAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a spray drying control process for human plasma that solves problems associated with prior art spray drying control processes. By measuring the exhaust gas temperature of the spray dryer during the process and adjusting the flow rate of the drying gas to maintain the desired temperature, the inventors have discovered that adjusting and maintaining the exhaust gas temperature by changing the flow rate of the drying gas results in a faster response rate than changing the temperature of the gas. The desired moisture content of the spray dried plasma is about 4% to about 10%.

Problems solved by technology

A long-standing need and challenge to the blood industry has been to provide safe, reliable and convenient blood products while preserving the efficacy and safety of those products in storage and when used in transfusion or as a source a medical treatments.

Method used

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  • Process control methods for obtaining and maintaining a desired moisture content of spray dried plasma
  • Process control methods for obtaining and maintaining a desired moisture content of spray dried plasma
  • Process control methods for obtaining and maintaining a desired moisture content of spray dried plasma

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0184]Plasma Protein Activity Correlated with Drying Gas Exhaust Temperature

[0185]We found that the most important parameter with respect to protein viability in dried plasma was the drying gas exhaust temperature. If dried plasma is exposed to an exhaust temperature higher than 60° C., even briefly, plasma protein activity degrades. Please note, during the drying process the surface of the wet plasma droplets is exposed to 125° C. but the droplet remains cool due to the evaporation process. A significant improvement in process consistency was achieved by actively controlling the exhaust temperature by varying the speed of the drying gas pump and, thus, the flow rate of the drying gas through the spray drying apparatus.

[0186]When bleeding occurs, the body causes coagulation factors, such as Fibrinogen and / or Factor V, to combine and produce a clot which stops bleeding. Insufficient protein activity may impair clot formation, resulting in excessive bleeding. Accordingly, it is desira...

example 2

[0189]Controlling Exhaust Gas Temperature Maintains Consistent Spray Drier Temperature

[0190]In this study, 220 mL of plasma was spray dried on the Velico Medical Alpha 1 spray drier apparatus using the configuration show in FIG. 8. Input parameters were as follows: Plasma fluid flow rate: 10 mL / minute; Aerosol gas flow rate: 20 L / minute; Drying gas initial temperature: 125° C.; Drying gas flow rate 550-750 L / minute; Drying gas exhaust temperature: 52° C. The exhaust gas temperature was maintained at about 52° C. by varying the drying gas flow rate.

[0191]To map the gradient in the spray drier during spray drying, temperature probes were placed at the drying head, the inlet of the collection filter bag and at the exhaust of the collection filter bag. In FIG. 9, temperature sensor T5 measures the inlet drying gas temperature; temperature sensor T8 measures the inlet collection filter bag temperature, temperature sensor T6 measures the exhaust gas temperature as it leaves the collection...

example 3

[0193]Plasma Powder Moisture Correlated with Exhaust Gas Temperature

[0194]The correlation between spray drier exhaust gas temperature and moisture content of the spray dried plasma was determined. Spray dryer parameters used were[0195]Drying Gas Flow Rate: 600-850 L / min[0196]Drying Gas Initial Temperature: 125-135° C.[0197]Drying Gas Exhaust Temperature: 30-70° C.[0198]Fluid Flow Rate: 8-10 ml / min[0199]Velico Medical Alpha 1 Spray Dryer

[0200]Exhaust gas temperature was controlled at various temperatures from 30° C. to 70° C. Residual moisture in the dried plasma was measured by the Karl Fisher method for dried plasma collected in the collection filter. FIG. 16 shows the residual moisture content of the dried plasma ranged from about 15% when the exhaust temperature was maintained at about 30° C. to about 4.0% when the exhaust temperature was maintained at about 70° C. As indicated above, when the spray drier was operated to keep the exhaust gas temperature from about 55-60° C., the ...

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Abstract

A method of controlling the moisture content of a spray dried product by measuring the drying gas flow exhaust temperature and adjusting the drying gas flow rate to maintain a predetermined exhaust temperature that results in the production of a spray dried product with a desired moisture content. A preferred product is spray dried human plasma.

Description

GOVERNMENT SUPPORT[0001]This invention was made with Government support under contract HS0100201200005C awarded by the Biomedical Advanced Research and Development Authority (BARDA). The Government has certain rights in the invention.BACKGROUND[0002]Making up about 55% of the total volume of whole blood, blood plasma is a whole blood component in which blood cells and other constituents of whole blood are suspended. Blood plasma further contains a mixture of over 700 proteins and additional substances that perform functions necessary for bodily health, including clotting, protein storage, and electrolytic balance, amongst others. When extracted from whole blood, blood plasma may be employed to replace bodily fluids, antibodies and clotting factors. Accordingly, blood plasma is extensively used in medical treatments.[0003]Spray drying is a process wherein a liquid containing solutes such as proteins and salts is aerosolized into small droplets. The moisture is then evaporated out of ...

Claims

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Application Information

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IPC IPC(8): F26B5/04
CPCF26B5/04A61K9/1688F26B3/12F26B3/06F26B5/065B65D81/266B65D51/30A61K9/16A61K9/1682A61K9/1617A61K35/16B01J19/06B01J2219/00177F26B3/04
Inventor KHAN, ABDUL, WAHIDWILT, MICHAELLUCIEN, RUD, KARLY
Owner VELICO MEDICAL
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