FluorPure-SG Series PTFE Pleated Filter Cartridge for GMP Gas Sterile Filtration Requirements

Materials of Construction

Filter Membrane

Hydrophobic PTFE

Support/Drainage

PP

Cage/End Cap

PP

Core

PP/316L Stainless Steel

Adaptor

PP/PP+Stainless Steel

O-rings

S/E/N/F

Sealed by hot-melt welding, no adhesive

Filter Dimensions

Outer Diameter

69mm

Inner Diameter

33mm

Length

5-40inches

Filtration Area

≥0.36m² (5inches)

≥0.74m²/10inches

Operating Conditions

Maximum Differential Pressure (forward)

5.2 bar @ 25℃, 1.9 bar @ 82℃

Maximum Differential Pressure (reverse)

2.1 bar @ 25℃

Biological Safety

Endotoxins

＜0.25 EU/mL

Extractables

＜15 mg/10inches

Sterilizable

Steam In-place

140℃ 30min

differential pressure＜0.3 bar

Autoclave

121℃ 30min

Quality Control

ISO 9001:2015 quality management system

100% integrity test

Filter cartridge is fully traceable

All materials comply with relevant requirements of CFR21

Bacteria (Pseudomonas diminuta) Aerosol Challenge Test TR≥10⁸

Bacteria Liquid Challenge Test TR≥10¹¹

CRPTFESG

Length

Pore Size

Adaptor

Seal Material

Core

005=5"

010=10"

020=20"

030=30"

040=40"

G10=0.01μm(gas)

005=0.05μm

010=0.10μm

020=0.20μm

045=0.45μm

0=DOE

1=222/Flat with 316L SS insert

3=222/Fin

4=222/Fin with 316L SS insert

5=226/Fin with 316L SS insert

6=226/Fin

7=226/Flat

8=226/Flat with 316L SS insert

S=Silicone

E=EPDM

N=Nitrile

F=Fluorine

Rubber

Blank=PP

T=Thickened PP

R=Reinforced PP

S=316L Stainless Steel