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Proteins from plasma, protein preparations, biological fluids

Home - Application - Biopharmaceuticals and medicine - Proteins from plasma, protein preparations, biological fluids

Membrane and deep microfiltration is widely used in plasma fractionation processes for the production of albumin, immunoglobulin and other therapeutic proteins. Contamination of the plasma components can lead to instability of the product, as well as to clogging of the subsequent filters of the system and requires mandatory prefiltration. In addition, clarification with microfiltration prefilters is widely used to remove particles before chromatography and ultrafiltration. Finishing membrane elements are used to reduce bioburden and sterilizing filtration of protein solutions that are not subjected to heat treatment.

 

 

Process Requirements

 

Preliminary filters should effectively remove microparticles without sorbing the desired fractions.

 

It is necessary to use filtering elements that are highly muddy, do not emit pollution into the filtrate (are pyrogen-free), provide high flow rates and a stable resource, that is, they have good economic efficiency.

 

Purposes of filtration

 

Prefiltration

 

Remove colloids, lipids, unnecessary types of proteins, particles before the next stage of purification. Protect chromatographic columns, ultrafiltration membranes, subsequent sterilizing filters.

 

Finishing (sterilizing) filtration

 

Ensure microbiological stability at intermediate stages of the process.

 

Provide sterilizing filtration prior to bottling.

 

Recommendations for filters "Technofilter"

 

Prefilters

 

Depending on the volume of the process and the processing step, we recommend using deep prefilters based on  micro-glass materials.  EPVSc and EPVS with a rating of 0.5-1 micron. The positively charged prefilter material of these series is very effective at removing colloidal contaminants. These prefilters are ideally suited for clarification and prefiltration of serums, proteins from plasma and other viscous biological solutions. have high dirt absorption, absorption properties, provide high efficiency of microparticle retention at high flow rate and low pressure drop.

 

Finishing Filters

 

To lower the bioburden at intermediate stages of the process, at the final stages of filling we recommend the use of a membrane filter cartridge of the brand EEPROM with the possibility of repeated sterilization and low protein binding.

 

 

 

CHARACTERISTICS

ADVANTAGES FOR CONSUMER

The filter is based on a reliable pleated polyester sulfone membrane with excellent performance characteristics

Wide chemical compatibility (pH 1-14).

Excellent thermal resistance (up to 100 ° C on water).

Low ability to bind proteins and proteins.

Longer service life due to increased surface area up to 0.75 m / 250 mm.

High efficiency of retention of bacteria and microorganisms (99.998%)

Available with pore sizes of 0.65, 0.45 and 0.2 microns. Guaranteed removal of microorganisms and bacteria

A pronounced asymmetric pore structure and an increased total porosity of the membrane

High filtering speed and small differential pressure reduce financial costs.

Reinforced construction, longer service life

Reliable preservation of the integrity of the filter under harsh operating conditions.

The possibility of multiple sterilization ensures economical operation.

100% control for quality assurance, integrity testing

Microbiological reliability-the breakthrough of delayed particles and microorganisms is excluded.

Guarantee the integrity and effective operation of the product. Can be checked by a special integrity test during operation

Non-toxic, pyrogen-free

Passed extensive tests and certified for use in the food industry, manufactured in accordance with the certified quality management system ISO 9001: 2000

 

 

Operational characteristics

 

The maximum operating temperature is up to 900C at 0.20 MPa

 

 

The maximum differential pressure is 0.5 MPa at 200 ° C, 0.20 MPa at 800 ° C

 

Rinsing with hot water and chemical. means (not less than 50 cycles) - 900С, 30 min

 

Sterilization by autoclaving and flowing steam in the line (not less than 20 cycles) - 1340С, 30 min

 

For sterilizing air filtration ("breathing" filters), we recommend membrane filter elements made of  EF.F4 with 0.2 μm pore size. For the organization of the filtration process we propose the body equipment - medical  filter holders of the DS series from high-quality stainless steel AISI 316L or AISI 304 for different number and height of the filter elements.

 

For the final choice of the scheme for the filtration process, please contact the specialists of  Technofilter.


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