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
• o FDA 21 CFR 177.1655
• 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.