PTFE 0.2μm Sterilizing-Grade Cartridge Filters
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Product Specifications—Cartridge Filter
5inch 10inch 20inch 30inch Dimensions
Diameter
Maximum Length69 mm
150 mm69 mm
320 mm69 mm
560 mm69 mm
800 mmFiltration Area 0.35 m2 0.7 m2 1.4 m2 2.1 m2 Pore Size 0.2 μm Materials of
ConstructionFilter membrane: Polytetrafluoroethylene (PTFE)
Supporting Layer: Polypropylene (PP)
O-rings of capsules vent: SiliconeLiner / Cartridge body: Polypropylene (PP)
End caps: Polypropylene/ Polycarbonate (PP/PC)Bacterial Retention >107 cfu/cm2 B. diminuta ( ATCC® 19146TM) Maximum Differential
DifferentialForward: 5.0 bar(72.5 psi)@ 25°C / 3.0 bar(43.5 psi)@ 80°C
Reverse: 2.0 bar(29.0 psi)@ 25℃Bubble Point ≥1200 mbar(17.4 psi)(wetted with 60% IPA, 20℃, compressed air) Diffusion Through a 60% IPA wet membrane at 1040 mbar (15 psi) (20℃, compressed air ) ≤6.5 mL/min ≤ 13 mL/min ≤ 26 mL/min ≤ 39 mL/min Water Intrusion at 2500 mbar (36 psi) (20℃, compressed air ) ≤ 0.25 mL/min ≤ 0.5 mL/min ≤ 1.0 mL/min ≤ 1.5 mL/min Sterilization Steam in place: 135℃, 60 min, 25 cycles
Autoclave: 135℃, 60 min, 25 cyclesBiological Safety All the construction components of this filter comply with the requirements for biological safety of Class VI plastics in current USP<88> Indirect Food Additive The primary construction components of this filter comply with the requirements for food
contact materials as stipulated in EU 1935 / 2004 / EC and FDA 21 CFR 177-182Cleanliness Cleanliness meets the requirements for nonfiber releasing filter as specified inFDA21 CFR211.72 and 210.3 (b) (5) (6), and the level of insoluble particles in rinsing liquid meets the requirements of USP< 788> Endotoxin The endotoxin level of cartridge rinsing liquid is <0.25 EU/mL as indicated by gel method, which complies with the requirements of USP<85> Integrity 100% has passed the integrity test Manufacturing Environment Manufactured in conformance with cGMP
Test Results of Flow Differential Pressure
Air Flow Rate and Pressure Drop -Alipore® TAHF 0.2μm Cartridge Filters Air Flow Rate and Pressure Drop -Alipore® TAHF 0.2μm Alicap L300 Capsule Filters
(KFBTA02S2B6S1A)