Product Specifications

5 inch

10 inch

20 inch

30 inch

Diameter
Maximum Length

69 mm
150 mm

69 mm
320 mm

69 mm
560 mm

69 mm
800 mm

Materials of

Construction

Membrane

Polytetrafluoroethylene (PTFE)

Supporting Layer

Polypropylene (PP)

O-rings

Silicone、Ethylene propylene diene monomer（EPDM）

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 ）

≤6.5 mL/min

≤13 mL/min

≤26 mL/min

≤39 mL/min

Water Intrusion

Test pressure 2500 mbar (36 psi) （20℃, compressed air ）

≤0.25 mL/min

≤0.5 mL/min

≤1.0 mL/min

≤1.5 mL/min

Working characteristics

Maximum Differential

Pressure

Forward: 7.0 bar（101.5 psi）@ 25°C/3.0 bar（43.5 psi）@ 80°C

Reverse: 2.0 bar（29.0 psi）@ 25°C

Sterilization

Resistance

In-line steam: 135℃, 60 min, 25 cycles

Autoclave: 135℃, 60 min, 25 cycles

Filtration Area

0.35 m²

0.7 m²

1.4 m²

2.1 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