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Plasma proteins, peptides, biological fluids filtration

Home - Application - Biopharmaceuticals and medicine - Plasma proteins, peptides, biological fluids

Depth and membrane 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, that is why  prefiltration is obligatory. In addition, clarification with microfiltration prefilters is widely used to remove particles before chromatography and ultrafiltration. Membrane cartridges for final filtration are used to reduce bioburden and for sterilizing filtration of protein solutions that are not subjected to heat treatment.

Process Requirements

• Prefilters should effectively remove microparticles without sorbing the desired fractions.

• Filters with high retained capacity, without emission of pollution into the filtrate (are pyrogen-free), provide high flow rates and a stable resource.

Purposes of filtration

Prefiltration

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

Finishing (sterilizing) filtration

• Ensure microbiological stability at intermediate stages of the process.

• Provide sterilizing filtration prior to bottling.

Recommendations for Filter Cartidges of NPP “Technofilter” using for filtration of plasma proteins, peptides, biological fluids

Prefiltration: depth prefilters  EPV.SC or EPV.S.

The filter cartridges on the base of microfiberglass  with pore size 0.5-1.0 µm. The positively charged prefilter material of these series is very effective for removing colloidal contaminants. These prefilters are ideally suited for clarification and prefiltration of serums, proteins from plasma and other viscous biological solutions. The advantage is high retained capacity, absorption properties, high efficiency of microparticle retention at high flow rate and low pressure drop.

Final filtration: EPM.PS

To decrease the bioburden at intermediate stages of the filtration process, at the final stages of filling we recommend to use membrane filter cartridges of the brand EPM.PS with the possibility of repeated sterilization and low protein binding.

CHARACTERISTICS

ADVANTAGES FOR CONSUMER

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

Wide chemical compatibility (pH 1-14).

Excellent thermal resistance (up to 100 ° C in 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 bacteria retention

 (99.998 %)

Available with pore sizes of 0.65, 0.45 and 0.20 microns. Guaranteed removal of microorganisms and bacteria

Highly asymmetric pore structure and an increased total porosity of the membrane

Low expenses due to high filtering speed and small differential pressure

Reinforced construction, longer service life

Reliable 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 90 ºC at 0.20 MPa

• The maximum differential pressure is 0.5 MPa at 20 °C, 0.20 MPa at 80 °C

• Rinsing with hot water and chemicals (not less than 50 cycles) – 90 °C, 30 min

• Sterilization by autoclaving and steam-in-line (not less than 20 cycles) – 134 °C, 30 min

Sterilizing air filtration ("breathing" filters): EPM.F4.

We recommend membrane filter cartridges made of  polytetrafluoroethylene EPM.F4 with 0.2 μm pore size.

Filter housings: DS-1-D(-/-)M – sanitary construction.

For the organization of the filtration process we propose the body equipment - the filter housing of the series DS sanitary construction made from high-quality steel AISI 316L or AISI 304.

Integrity test: TECHNOCHEK.

Device for monitoring the integrity of membrane filtration systems - TECHNOCHEK.

For the final choice of the scheme for filtration of plasma proteins, peptides, biological fluids, please contact specialists of NPP “Technofilter”.


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