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Optiseal Cartridge Filter
Description:
Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic
Trade Name:
Optiseal
Qty/Pk:
6
Nitrogen Diffusion at 23 °C:
≤6 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water
Filtration Area, m²:
0.18
Maximum Differential Pressure, bar (psid):
Forward: 5.5 (80) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 135 °C. Reverse: 4.1 (60)
Bubble Point at 23 °C:
≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water
Cartridge Nominal Length, in (cm):
4 (10)
Pore Size (µm):
0.2
Wettability:
Hydrophobic
Sterilization:
80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C; 80 autoclave cycles of 30 min @ 135 °C
HydroCorr:
≤0.20 mL/min with water @ 2.6 bar (38 psig)
Good Manufacturing Practices:
This product was manufactured in a facility which adheres to Good Manufacturing Practices.
Bacterial Retention:
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables:
The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Product Name:
Optiseal Cartridge Filter
Non-Fiber Releasing:
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Bacterial Endotoxins:
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Device Material:
Polypropylene
Configuration:
Cartridge
Chemistry:
Hydrophobic PTFE
Cartridge Code:
Double O-rings (2-123) with hold-down tabs
Media:
Aervent
Support Material:
Polypropylene
Packaging:
Double Easy-Open bag
Seal Material:
Silicone
Device Size (in):
4