Applications

• Application

  • Blood and Plasma  
  • Vaccine Production  

Biological Information

• Bacterial Retention

  Quantitative Retention of 1 × E7 CFU/cm²

Compliance Information

• Bacterial Endotoxins

  < 0.25 EU/mL as determined by the LAL test  

• Biological Reactivity

  All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).  

• Extractables

  The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".  

Connections (Physical)

• Connector Inlet

  2-Flange Bayonet Adapter with 226 Double O-ring (25)  

• Connector Outlet

  2-Flange Bayonet Adapter with 226 Double O-ring (25)  

Dimensions

• Filter Size

  30"(1.8 m² / 19.4 ft²)  

• Filtration Area

  1.8 m² / 19.4 ft²  

• Outer Diameter

  70 mm  

General Specifications

• Capsule/Cartridge Format

  Cartridges  

• Maximum Allowable Back Pressure

  2 bar (29 psi) at 20°C; 1 bar (14.5 psi) at 80°C  

• Maximum Diffusion

  45 mL/min at 2.5 bar | 36 psi  

• Minimum Required Bubble Point

  3.2 bar | 46 psi  

• Vent Valve

  N/A  

Materials of Construction

• Filter Material

  Cellulose Acetate (CA)  

• Housing Material

  Polypropylene (PP)  

• Material o-ring | seal

  Silicone (SI)  

• Support Fleece

  Polypropylene (PP)  

Operating Conditions

• Maximum Differential Pressure

  20 °C: 5 bar; 80 °C: 2 bar  

• Maximum Operating Pressure

  5 bar (72.5 psi)  

Physicochemical Information

• Non-Fiber Releasing

  This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.  

• Pore Size Final-filter

  0.2 µm  

• Pore Size Pre-filter

  0.45 µm  

Product Information

• Brand

  Cartopore  

Sterility

• Sterilization Method

  Autoclavable & In-Line Steam Sterilizable  

Usage Protocols

• Sterilization Procedures

  • In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles  
  • Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles