PTFE 0.2μm Sterilizing-Grade Capsule Filters

Product Specification

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

Filtration Area

380 cm²

670 cm²

0.17 m²

0.28 m²

Pore Size

0.2 μm

Materials of

Construction

Filter membrane: Polytetrafluoroethylene (PTFE)    Supporting Layer: Polypropylene (PP)

• rings of capsules vent: Silicone
• Liner / Cartridge body / End caps / Housing: Polypropylene (PP)

Bacterial Retention

 ＞107 cfu/cm2 B. diminuta ( ATCC® 19146TM )

Maximum Differential Pressure

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 °C

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 ）

-

≤ 1.2 mL/min

≤ 3.1 mL/min

≤ 5.2 mL/min

Sterilization

Autoclave(A): 131℃, 30min, 10 cycles

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

Cleanliness

Cleanliness meets the requirements for nonfiber releasing filter as specified in FDA 21 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

Filters are 100% integrity tested

Manufacturing

Environment

Manufactured in conformance with cGMP