Property
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.
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
Quality compliance
- 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
