Technical Data Sheet - PureFlo D25C Filter Capsule

PureFlo D25C series 25mm disc capsule filters have been specially designed for simple, quick, and efficient filtration of fluids and gases used in laboratory, pilot, and small-scale applications. These filters are appropriate for applications where sterility of the affluent is mandatory (Sterile Compounding and Pharmaceutical use). The small compact design of the filter capsule reduces hold-up volume and exposure to hazardous chemicals. The product contains a pharmaceutical grade PTFE membrane (Sterilizing Grade) and the filters are built in a 10,000-class clean room, flushed, dried and 100% integrity tested prior to packaging. The product is factory sterilized by Ethylene Oxide gas (ETO) ensuring sterility.

Materials of Construction

Filter Membrane: Pharmaceutical Grade Polytetrafluoroethylene (PTFE) Sterilizing Grade - Hydrophobic

Micron Rating: 0.2 µm

Supports: Polypropylene

Capsule Body: Polypropylene

Filter Dimensions and Specifications

Outer Diameter: 33 mm (1.30”)

Capsule Body Thickness: 5.1 mm (0.200”)

Length, Fitting to Fitting: 24 mm (0.945”)

Filter Area: 4.6 cm2 (0.7 in2); competitive standard contains 3.5 cm2 Sterilization: The filter is factory sterilized by Ethylene Oxide Gas (ETO) Inlet Fitting: Luer Loc Female

Outlet Fitting: Luer Loc Male

Volume Filtered: 100 ml to 320 ml

Allowable Flowrate: 8 ml per min to 320 ml per min

Pore Size

Min, Bubble Point, 25oC (60% IPA)

Challenge Microorganisms

CFU per cm2

0.20 µm

>1.2 bar (18 psi)

Brevundimonas Diminuta (ATCC 19146)

10⁷

 

 

Operating Parameters

Maximum Working Pressure: 5.5 bar (80 Psi) @ 25 oC (77 oF)

Maximum differential Pressure (forward): 4.1 bar (60 Psi) @ 25 oC (77 oF)

Maximum differential Pressure (reverse): 2.1 bar (30 Psi) @ 25 oC (77 oF)

Maximum Operating Temperature: 80 oC (176 oF)

Safety

UPS Bacteria Endotoxins: <25 EU/ml

Product was 100% Integrity Tested and flushed with filtered water @ 0.05 µm

Sterilization

The product can be autoclaved 10 cycles at 125 oC (257 oF) for 30 minutes. This product cannot be sterilized by steam-in-place (SIP).

Regulatory

  • Complies with USP 797 Guidelines
  • ASTM F838-05 - Bacterial Retention
  • USP Class VI - Biological Reactivity
  • ISO 10993-Part 5 - Cytotoxicity
  • ISO 14001; ISO 13485; OHSMS 18001 Certified
  • ASTM Hemolysis testing
  • Human/Veterinarian Use – Applies when the requirements from CGMP CFR part 210 and 211 and additional requirements 21 CFR part 600 and 21 CFR part 680 are used in the aseptic processing.

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