PTFE 0.2μm Sterilizing-Grade Cartridge Filters
Product Specifications—Cartridge Filter
| 5inch | 10inch | 20inch | 30inch | ||
|
Dimensions
Diameter |
69 mm |
69 mm |
69 mm |
69 mm |
|
| Filtration Area | 0.35 m2 | 0.7 m2 | 1.4 m2 | 2.1 m2 | |
| Pore Size | 0.2 μm | ||||
| Materials of Construction |
Filter membrane: Polytetrafluoroethylene (PTFE) Supporting Layer: Polypropylene (PP) Liner / Cartridge body: Polypropylene (PP) |
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| Bacterial Retention | ＞107 cfu/cm2 B. diminuta ( ATCC® 19146TM） | ||||
| Maximum
Differential Differential |
Forward: 5.0 bar（72.5 psi）@ 25°C / 3.0 bar（43.5 psi）@ 80°C Reverse: 2.0 bar（29.0 psi）@ 25℃ |
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| 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 cycles |
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| Biological 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 177-182 |
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| Cleanliness | 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 |
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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）
