| Cartridge Filters |
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Per 10-inch Cartridge |
| Nominal Dimensions |
| Outside diameter: |
70 mm (2.8 in.) |
| Maximum length: |
| 10-inch cartridge: |
319 mm (12.6 in.) |
| 20-inch cartridge: |
568 mm (22.0 in.) |
| 30-inch cartridge: |
816 mm (32.1 in.) |
| Filtration Area |
0.65 m2 (7.0 ft2) |
| Materials of Construction |
| Filter media: |
PTFE membrane |
| Supports: |
Polypropylene |
| Structural components: |
Polypropylene |
| O-rings: |
EPDM |
| Maximum Differential Pressure |
| Forward: |
5.5 bar (80 psid) at ambient temperature 1.8 bar (25 psid) at 80 °C |
| Reverse: |
4.1 bar (60 psid) at ambient temperature |
| Diffusion at 23 °C |
Through a 70/30 IPA/water wet membrane at 965 mbar (14 psig) nitrogen: ≤ 24 cc/min per 10-inch cartridge |
| Bubble Point at 23 °C |
≥ 1310 mbar (19 psig) in a 70/30 IPA/water wet membrane using nitrogen |
| Gravimetric Extractables |
After autoclaving and a 24-hour soak in 70/30 IPA/water at controlled room temperature: ≤ 35 mg per 10-inch cartridge |
| Bacterial Endotoxin |
Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. |
| Bacterial Retention |
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology. |
| Sterilization |
May be steam sterilized 50 times (forward) and 50 times (reverse) for 30 minutes at 135 °C. |
| Non-Fiber Releasing |
PTFE membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). |
| Component Material Toxicity |
Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. This product
is non-cytotoxic per ISOR 10993-5 and USP <87> Cytotoxicity MEM Elution Test. |
