PTFE 0.2μm Sterilizing-Grade Capsule Filters

Product Specifications

Alicap^® L300

Alicap^® L600

Alicap^® L02

Alicap^® L04

Body Diameter
Maximum Width
Maximum Length

67 mm
77 mm
100.5 mm

67 mm
77 mm
122 mm

72 mm
96 mm
164 mm

72 mm
96 mm
217 mm

Materials 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 ）

-

≤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^® 19146^TM )

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