[GVS] Hollow Fiber

[GVS] Hollow Fiber

Applications

• Lysate clarification

• Upstream cell perfusion culture

• Inclusion body clarification and renaturation

• Nanoparticle Diafiltration and Separation

• Liposome concentration and diafiltration

• Cell concentration, clarification, diafiltration

• Purification, concentration, diafiltration of proteins and nucleic acids

• Virus purification, concentration, diafiltration

 

The production raw materials of this product meet the requirements of EMEA/410/01.

The technical parameters of this product meet the following regulatory requirements:

• Biological Reactivity Test, In Vivo per USP

• 21CFR177 Indirect Food Additives

• L929 MEM Elution test - ISO 10993-5(Cytotoxicity)

• Hemolysis - Rabbit Blood (direct contact) - ISO 10993-4

The production of this product meets the requirements of 15013485:2016 quality management system.

 

USP <88> Class VI Testing All flow path materials have been tested confirmed to the USP <88> Class VI biocompatibility standards

Bioburden Bioburden of a single hollow fiber column < 1000 Colony Forming Units (CFU)

Pyrogen Hollow fiber filter production and assembly are carried out under strictly monitored conditions to ensure minimal endotoxin levels, but the product line cannot be guaranteed to be completely pyrogen-free

Free of Animal Origin: Synthetic and processed materials used in fiber synthesis that do not contain any animal or derived substances

Shipping and Packaging Verification GVS has verified product shipping/packaging configurations to ISTA 3A (2008) requirements to ensure that sterile products are adequately protected from damage during shipping

Product Validity Non-sterile filters are valid for 5 years from the date of manufacture