Applications

• Industry

  Pharma / Biotech  

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

  1/2" Single Stepped Hose Barb  

• Connector Outlet

  1/2" Single Stepped Hose Barb  

Dimensions

• Filter Size

  size 9 (0.2 m² / 2.2 ft²)  

• Filtration Area

  0.2 m²  

General Specifications  

• Maximum Diffusion

  4 mL/min at 0.7 bar  

• Minimum Required Bubble Point

  1.0 bar | 14.5 psi  

Materials of Construction

• Housing Material

  Polypropylene (PP)  

• Material o-ring | seal

  Silicone (SI)  

• Support Fleece

  Polypropylene (PP)  

Operating Conditions

• Maximum Differential Pressure

  20 °C: 5 bar; 50 °C: 3 bar  

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  

Product Information

• Brand

  Cartopore

Sterility

• Sterilization Method

  Autoclavable  

Usage Protocols

• Sterilization Procedures

  Autoclaving: Min. 25 cycles at max. 134 °C, 2 bar | 29 psi, 30 min.