Applications

• Application
  Single Use Processing
• Industry
  Pharma / Biotech

Biological Information

• Bacterial Retention
  Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology

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 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".
• GMP Compliance
  This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.

Connections (Physical)

• Connector Inlet
  1/4" Multiple Stepped Hose Barb
• Connector Outlet
  1/4" Multiple Stepped Hose Barb

Dimensions

• Filter Size
  size 4 (0.021 m² / 0.22 ft²)
• Filtration Area
  0.021 m²
• Outer Diameter
  63 mm (46 mm without Connection / Valves)

General Specifications

• Capsule/Cartridge Format
  Capsules Size 4&5
• Filter Format
  Capsules
• Maximum Allowable Back Pressure
  2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
• Maximum Diffusion
  1.1 mL/min at 2.5 bar | 36 psi
• Minimum Required Bubble Point
  3.5 bar | 51 psi
• Vent Valve
  Standard

Materials of Construction

• Filter Material
  Polyethersulfone (PES)
• Housing Material
  Polypropylene (PP)
• Material o-ring | seal
  Silicone (SI)

Operating Conditions

• Maximum Differential Pressure
  20 °C: 4 bar; 50 °C: 2 bar
• Maximum Operating Pressure
  4 bar (58 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
  Sartopore® Platinum
• Filter Type
  Liquid Filters

Sterility

• Delivery Condition
  Sterile - Autoclaved
• Sterilization Method
  Autoclavable

Usage Protocols

• Sterilization Procedures
  Autoclaving: at 134°C, 30 min, 2 bar, min. 5 Cycles