PTFE Filter Cartridges
0.2 Micron Absolute Filter Cartridges

The PTFE Pharmaceutical Liquid Bacterial Retentive (LBR) cartridge is validated to produce sterility through retention of Brevundimonas diminuta per HIMA guidelines. PTFE exhibits high air and liquid flow rates as well as being a sterilizing grade filter that uses expanded PTFE membrane. Users expecting the ultimate flow rate performance for liquid or air sterilization will find the Proflow Il LER to be their preferred choice.
PTFE cartridges are manufactured utilizing a certified Class 10,000 cleanroom that operates under guidelines of the FDA's Good Manu-facturing Practices for Medical Devices All modules are flushed with high purity, non-pyrogenic deionized water, 100% integrity tested and serialized to provide complete product traceability. A Certificate of Quality accompanies each completed cartridge detailing all lot, audit and general testing requirements.

TYPICAL FLOW RATES
AIR: 44 scfm/psid (18 slpm/mbar)
LIQUID: 1.9 gpm/psid (1O4 Ipm/bar)

MATERIALS OF CONSTRUCTION
Membrane PTFE
Support Layers Polypropylene
Cartridge Hardware Polypropylene
All components meet: USP XXlll Class VI -121ºC criteria and are thermally bonded to assume integrity and minimize extractable.

STEAM STERILIZABLE AND SANITIZATBLE
Cartridges may be Steamed or Autoclaved for over 100 one-hour cycles @ 275ºF (145ºC). Cartridges may also be chemically sanitized in place using common sanitizing agents. Please contact SWT for detailed procedures.

BACTERIA RETENTION
Bacteria retention greater than 107/cm² per HIMA methodology for 0.2 micron sterilizing grade filters using Brevundimonas dominuta.
EFFECTIVE FILTRATION AREA
9.3 ft² (0.86 m²)

MAXIMUM OPERATING DIFFERENTIAL PRESSURE
Forward: 8O psid (5.5 bar) @ 75ºF (24ºC)
Reverse: 50 psid (3.4 bar) @ 75ºF (24ºC)

TRACEABILITY
Each PROFLOW II LBR cartridge is given a unique serial number to provide immediate product traceability.

INTEGRITY TEST VALUES
(Tested in 60% Isopropanol / 40% Deionized Water)

Micron
Pore Size
Bubble
Point
Diffusional FLow
Test Pressure
µm psig cc/min psig bar
0.2 >21 <25 17 1.17


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