Solutions of Blood Products Process Filtration

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Immunoglobulins include static C, muscle C and specific immunoglobulins. Static C is a complete, unmodified, natural IgG antibody with a purity of 98%, which is intended for intravenous infusion and is similar to that of human immune globulin. Globulin (myocardial infusion) has a fast-acting, compared to coagulation factors: human fibrinogen, human coagulation factor VIII (factor VIII). ) and the human prothrombin complex (PCC). 


Blood makes up about 8% of body weight (v/w), plasma makes up 50% of whole blood (v/w), and plasma proteins make up about 6- 7% and 92% are water. There are more than 200 known plasma proteins, of which more than 100 have been purified, more than 70 are well studied, and more than 70 have been manufactured. There are more than 20 types of products and about 10 types of finished products in China. Their main products include the following.


50%-60% of plasma protein and 80% of osmolality comes from albumin, which has the ability to increase circulating blood volume and maintain the role of osmolarity of the organism. Albumin is the only blood product allowed to be imported into China, with importers supplying between 50% and 60% of the albumin.


Immunoglobulins include static C, muscle C and specific immunoglobulins. Static C is a complete, unmodified, natural IgG antibody with a purity of 98%, which is intended for intravenous infusion and is similar to that of human immune globulin. Globulin (myocardial infusion) has a fast-acting, compared to coagulation factors: human fibrinogen, human coagulation factor VIII (factor VIII). ) and the human prothrombin complex (PCC).


The main production method of blood products is the low-temperature ethanol method, which uses mixed plasma as the raw material to gradually reduce the acidity (from pH 7.0 to pH 4.0). Increasing the ethanol concentration (from 0 to 40%) and simultaneously decreasing the temperature (from 2°C to -2°C), various proteins in different conditions the following are precipitated from the solution as components (crude products) in steps and separated by centrifugation or filtration.



IVIG 

IVIG Process.jpg



① Ethanol Filtration

Particle Control

Greclary CHV -Glass Fiber

Excesal CHE -PP

Excesal CHC -PP
Excesal CHT -PP

Safetect PME -PES


Sterile Filtration

Purcise SLE -Double Layer PES

Corevital SAF -Double Layer PES

Corevital SMD -PVDF



② Vent

Safesure AFM -Hydrophobic PTFE

Corevital APB -Hydrophobic PVDF



Pressure Filtration

Roheap CSD



④ Clarification Filtration

Roheap CSD


⑤ Column / TFF Protection

Bioburden Reduction/Pre-filtraiton

Safetect PME -PES

Purcise PLE -Double Layer PES

Purcise PAF -PES

Corevital PMD -PVDF


Sterilization Filtration

Purcise SLE -Double Layer PES

Corevital SAF -Double Layer PES

Corevital SMD -PVDF



⑥ Concentration and Purification

Consieve®UET TFF
 ( Cassettes /Stainless Holder /System 
)




⑦ Buffer Filtration

Bioburden Reduction/Pre-filtraiton

Safetect PME -PES

Purcise PLE -Double Layer PES

Purcise PAF -PES

Corevital PMD -PVDF




⑧ Sterile Filtration

Purcise SLE -Double Layer PES

Corevital SAF -Double Layer PES

Corevital SMD -PVDF



⑨ 0.1μm filtration

Purcise MLE -Double Layer PES



⑩ nanofiltration

Being Developed