PES virus filter

Introduction

Virus contamination in the production of biological products is of particular concern, mainly concentrated in the endogenous viruses of cell lines and exogenous viruses (such as parvoviruses) introduced in the production process. Biotherapeutics derived from cell lines have so far not been involved in the spread of viruses to humans. However, in order to ensure product safety, known procedures for the removal or elimination of viruses should be part of the production and processing of all biological products. To ensure the safety of virus removal of biological products, the use of membrane screening effect and heterosexual charge adsorption method to remove virus.

Filters specifically designed to remove viruses from biological products (biopharmaceuticals, blood products), culture media. We have two kinds of filter: folding and flat plate, there are areas dedicated to the high protein concentration required for the production of biological products, which can meet the needs of large amount and short time filtering.

For blood products, the threat of viral contamination is extremely high, Because blood is known to carry many human pathogenic viruses, and transmission of viruses to humans can be achieved by using virus-contaminated products. However, recent improvements in blood screening and changes in manufacturing (to ensure virus removal during decontamination processes) have reduced the risk of viral contamination in blood product-derived products.

 

Features

• Filter protein solutions at high flow rates

• High protein recovery rate

• The specially treated membrane can greatly increase the filtration capacity and prevent the clogging of the virus filter

• Specific adsorption of impurities, even viruses smaller than the membrane pore size can be effectively removed

• High quality stability, scalability and security

• Each product is 100% integrity tested

• Dynamic load testing ensures high capacity at high flow rates

• Stable physical and chemical properties, extensive pH compatibility

 

Technical Parameter

Connector	Luer or Quick Clamp Fittings
Animal-derived	All filters are made of synthetic materials and are not derived from animals
Integrity test	Pass the aerosol test
Operating pressure	Inlet pressure≤3bar
Operating temperature	≤37℃
Alkali resistance	45min At 25°C, the maximum resistance to 0.5N sodium hydroxide is 45min
pH	2-13
Sterilization method	Steam sterilization, ethylene oxide sterilization, gamma-ray sterilization

 

Ordre Information

Area	Package Specification	Model
3.1 cm2	10	PE0000031L10R
0.02m2	1	PE0002000L01R
0.07m2	1	PE0007000L01R
0.2m2	1	PE0020000L01R
0.55 m2	1	PE0055000L01R
1.65 m2	1	PE0165000L01R

Protein recovery and virus removal log

	Thrombin	Monoclonal antibodies	polyclonal antibody	albumin
20nm	98%	98%	98%	98%
LRV parvovirus LRV	＞5	＞5	＞5	＞5

LRV: virus removal log

Virus filter selection and constant pressure test

Correlation between flow rate and filtration pressure for 3% IgG solution

The flow rate is positively related to the filtration pressure, the higher the pressure, the faster the flow rate

The relationship between IgG flux and IgG concentration

The filter can withstand high concentration solutions, and improve the protein handling capacity

Remove functions for PPV and MVM

No virus particles detected in filtration

Test solution: add 0.5% by weight to 5% IgG for each virus solution

3 bar Filtration pressure: 3 bar

 

Quality Assurance

●The perfect production quality system ensures the high flux and high capacity of the virus removal filter, as well as the retention capacity of parvovirus

●Independent testing of each product ensures membrane module integrity

About Us

Hangzhou Guidling Technology CO.,LTD is a manufacturer focusing on clarification, separation and purification of biopharmaceutical: The products are widely used in antibodies, vaccines, diagnostics, blood products, polysaccharides, endotoxin filtration, viruses, culture medium ,etc. as well as industrial fluid filtration at this stage. Guidling Technology has successfully developed centrifugal filter devices, ultrafiltration µfiltration cassettes and TFF device and system, depth filter modules, virus clearance filter, etc. which can fully meet the requirements of concentration and desalination, virus clearance, fermentation liquid clarification and other processes in biological products. Our membranes and membrane filters are widely used in the concentration, extraction and separation of prefiltration, microfiltration, ultrafiltration and nanofiltration. Among the many product pipelines, from laboratory sample processing, small-scale trials, pilot-scale trials, to scale-up production, you will be able to find products that meet your process needs.

 

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