PTFE 0.2μm Sterilizing-Grade Capsule Filters
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Product Specifications—Alicap®L-type Capsule Filters
Product Specifications
Alicap® L300
Alicap® L600
Alicap® L02
Alicap® L04
Body Diameter
Maximum Width
Maximum Length67 mm
77 mm
100.5 mm67 mm
77 mm
122 mm72 mm
96 mm
164 mm72 mm
96 mm
217 mmMaterials of
Construction
Membrane
Polytetrafluoroethylene (PTFE)
Supporting Layer
Polypropylene (PP)
O-rings
Silicone
Core/Cage/End caps/Housing
Polypropylene (PP)
Integrity testing
Bubble Point
≥1200 mbar(17.4 psi)(wetted with 60% IPA, 20℃, compressed air)
Diffusion Flow
Test pressure 1040 mbar (15 psi)(wetted with 60% IPA, 20℃, compressed air )
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≤1.2 mL/min
≤3.1 mL/min
≤5.2 mL/min
Working characteristics
Maximum Differential
Pressure
Forward: 5.0 bar(72.5 psi)@ 25℃/3.0 bar(43.5 psi)@ 80℃
Reverse: 2.0 bar(29.0 psi)@ 25℃
Sterilization
Resistance
Autoclave(A): 131℃, 30 min, 10 cycles
Filtration Area
380 cm2
670 cm2
0.17 m2
0.28 m2
Pore Size
0.2 μm
Bacterial Retention
>107 cfu/cm2 B. diminuta ( ATCC® 19146TM )
Biological Safety
All construction components meet the biological safety requirements refering to USP<88> Class VI plastic and USP<87>
Indirect Food Additive
All component materials meet the requirements of Indirect Food Additive cited in EU 1935/2004/EC and FDA 21 CFR 177-182
Cleanliness
Meets the requirements for a ‘non-fiber releasing’ filter defined in FDA 21 CFR 211.72 and 210.3 (b) (5) (6), and particulate matter meets the requirements of USP<788>
Endotoxin
Endotoxin﹤0.25 EU/mL by LAL test method, which complies with the requirements of USP<85>
Manufacturing
Integrity
100% integrity test passed
Manufacturing
Environment
Manufactured in conformance with cGMP
Test Results of Flow Differential Pressure
Air Flow Rate and Pressure Drop -Alipore® TAHF 0.2μm Alicap L300 Capsule Filters