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The Vital Role of Filtration in Blood Product Processing

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Blood products are various human plasma protein products, including human blood albumin, human placental blood albumin, immunoglobulin, and so on.

The raw material of blood products is plasma. In human plasma 92%-93% is water, only 7%-8% is protein, and blood products are made from this part of the protein separation and purification.

The raw material for blood products is uniquely defined, however, in order to advance the rapid development of blood products, there is a need to implement a universal, safe, and efficient process with reliable support equipment. This blog focuses on research on processes that require the use of filtration.

Challenges in the production of blood products

Challenges in the production of blood products

In the production process of blood products, it is important to ensure that the conditions are gentle, so that all types of proteins are not inactivated and denatured, and that the damage to plasma proteins is minimized as much as possible.

In the production process of blood products, pathogens must be inactivated or removed, but there are some shortcomings in the commonly used methods of inactivating and removing viruses.

Maintaining mild production conditions is essential to prevent inactivation and denaturation of proteins. By using mild process conditions, damage to plasma proteins is minimized to ensure the bioactivity and quality of the product.

At the same time, a well-designed process is important to ensure the safety and quality of blood products. It includes multiple stages such as clarification pretreatment of plasma raw materials, filtration steps, chromatography, ultrafiltration, etc. to ensure proper control and monitoring at each step.

Process Flow for the Production of Blood Products

Typical processes typically utilize a low-temperature ethanol method by stepwise reduction of pH, regulation of ethanol concentration and temperature. pH is a measure of the acidity or alkalinity of a solution. Gradually lowering the pH means gradually reducing the alkalinity of the solution during the process, making it more acidic.

It is also necessary to gradually adjust the concentration of ethanol. Ethanol can have an inactivating effect on microorganisms at certain concentrations, but too high a concentration may adversely affect plasma proteins, so precise control is needed.

The temperature of the solution will also be regulated during the temperature-regulated treatment. Low-temperature conditions may contribute to the effective action of ethanol and slow down the denaturation of proteins. The various proteins are precipitated in steps under the conditions and then separated by filtration and centrifugation.

Blood components

Clarification Pretreatment of Plasma Raw Material

Precipitates from the plasma fractionation process can be separated by centrifugation or filtration. Centrifugation is a method of separating different components of a mixture by rotation. In the plasma fractionation process, a centrifuge centrifuges the plasma mixture at a high speed so that the precipitate is forced to deposit at the bottom of the centrifuge tube, while the upper layer is relatively clear plasma.

Pre-filtration for plasma fractionation

Plasma fractionation requires the use of high-performance prefilters to remove impurities and protect subsequent filters. After low-speed gradient centrifugation, the crude liquid is separated by sedimentation and then deep-filtered to achieve plasma clarification and filtration.

Chromatography

In chemical analysis, chromatography is a laboratory technique for the separation of a mixture into its components. The mixture is dissolved in a fluid solvent (gas or liquid) called the mobile phase, which carries it through a system (a column, a capillary tube, a plate, or a sheet) on which a material called the stationary phase is fixed.

Ultrafiltration

Ultrafiltration, a vital component in concentration processes, employs specialized membrane packages to fulfill essential requirements. These packages utilize advanced membrane technology, selectively sieving molecules based on size. This allows smaller solutes to permeate through while retaining larger particles. This efficient filtration process meets the basic needs of concentration, offering a versatile and effective method for separating and purifying substances in various applications.

Secondary Chromatography

Affinity chromatography is used again to obtain target plasma proteins quickly and efficiently. To date, affinity chromatography has been used to produce a variety of licensable medical plasma products.

De-virtualization

Viruses are often filtered out using de-viralization filters. These filters selectively target and trap viral particles, ensuring that the filtered substance remains free from viral contaminants. Applied in various fields, from water purification to biotechnological processes, de-viralization filters play a crucial role in upholding health and safety standards.

Sterilization filtration and fractionation

Terminal filtration and sterilization with membranes with a pore size of 0.22 μm are commonly used, followed by dispensing.

Purpose of prefiltration and sterilization

Purpose of prefiltration and sterilization

For the preparation of blood products, processes such as filtration and chromatography are particularly important. Specifically, the target plasma proteins can be obtained step by step through preliminary filtration, multistage precipitation and filtration, chromatography, and ultrafiltration concentration. And in the preparation of blood products, the pretreatment of plasma and the final terminal filtration, as the first and last step, should not be underestimated.

Pre-filtration

Since blood contains a large number of microorganisms and impurities, and is very easy to combine with proteins, in order to ensure the purity and safety of blood products, after obtaining plasma raw materials, it is usually necessary to carry out preliminary filtration, which is an easier step compared with the de-virtualization filtration and chromatography. Gums, aggregates, non-target proteins, lipids, and particles are removed prior to downstream purification and protection of downstream sterilizing filters or columns.

A simple primary filtration step to obtain a crude liquid is usually performed using filters that remove particles and have a high retention rate. The Ultrapure series of membrane pleated cartridges offer extremely high filtration efficiency and absolute precision filtration for particles ranging from 0.10 µm to 100 µm, and these cartridges have a filtration efficiency of up to 99.9% at specified pore sizes, ensuring reliable and efficient filtration performance. They also protect downstream sterilizing filters for longer service life.

Sterilization Filtration

The purpose of sterilization filtration is to control the level of microorganisms during the production of blood products. Sterilization filtration is a process that removes microorganisms from a liquid stream without negatively affecting the quality of the product itself, utilizing physical retention to remove bacteria from the liquid or air clock in order to achieve sterility.

Throughout the process, terminal filtration is often carried out using membranes with a pore size of 0.22 μm to ensure product safety and efficiency, enabling dispensing of the sterilized product.

The Stery series of cartridge filters not only provide excellent microbial retention but are also cost-effective and can be sterilized using steam or hot water to extend service life and reduce replacement costs. The Story series of cartridge filters are available in a wide variety of sizes and sizes and are available in a wide range of sizes and sizes.

Sterilization Filtration

Conclusion

The key to the production of blood products lies in good workmanship and reliable equipment. sanitek offers a full range of pre-filtration and sterilizing filtration products for the production of blood products, designed to meet the highest standards in the industry.

Our products include high-performance prefilters, advanced sterilizing filters, and a variety of innovative membrane technologies.

Please feel free to contact us if you are interested in our products or have any related needs.

Whether you are looking for a new technological frontier or a solution to maximize production efficiency, we look forward to working with you to drive innovation and growth in the blood products manufacturing sector.

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