Gasket / O-Ring Material
Ethylene Propylene Rubber
Unrivalled hot air filter for long life
Emflon HTPFR filter cartridges are specifically designed for the sterile filtration of air, gas and vent service in critical, hightemperature and ozonated-water venting applications. They can also be considered for use in oxygen-enriched air applications in the biopharmaceutical and biotechnology industries (see Pall publication USTR2311a). High-temperature applications include autoclave, fermentation inlet air, aseptic packaging/blow-fill-seal and hot Water For Injection (WFI) tank vents. These sterile air filters incorporate a double-layer (0.2 μm) of inherently hydrophobic, Pall-manufactured polytetrafluoroethylene (PTFE) membrane. The polypropylene hardware is specially formulated with protective anti-oxidants and the filter's support and drainage layers are made of polyphenylene sulfide (PPS) polymer. Oxidation-resistant filter components allow extended use in air/vent service up to 100 °C and for shorter periods up to 120 °C.
and easy water intrusion testing
- Designed for Water Intrusion Test (WIT)
- Oxidation-resistant materials of construction
- Proprietary, Pall-manufactured PTFE membrane
- Validated with B. diminuta at >107 cfu/cm2
- Fully validated under stringent microbial, phage and particulate challenge tests
- Designed for multi-cycle autoclave and in situ steam
- High flow rates, low pressure drops
- Laser-etched part/serial number and 2D matrix code
- No alcohol required
- Long service life in hot air and vent applications; also suitable for oxygen-enriched fermenter applications (see Pall publication USTR2311a)
- Hydrophobic membrane, subject to rigorous Pall manufacturing and quality controls; secure supply source
- Provides sterile air/gas under wet and dry conditions, meets cGMP sterilizing-grade filter requirements
- Improves microbial safety; mitigates virus contamination risk
- Robust construction offers enhanced steam resistance
- Allows smaller filtration systems, reducing installation and operational costs
- Easily traceable; product information easily read or scanned with a barcode reader (e.g. the Palltronic® barcode reader)
Certified For Pharmaceutical UseEmflon HTPFR filter cartridges are qualified for use in pharmaceutical GMP manufacturing. Each filter is supplied with a Certificate of Test confirming pharmaceutical industry requirements for fabrication integrity, effluent quality and biological safety testing. Pall filters are manufactured in a controlled environment under a quality management system certified to ISO9001:2008. All Emflon HTPFR cartridges are Forward Flow integrity-tested in manufacturing, correlated to bacterial retention in liquids and bacteriophage (virus) retention in air, and are fully traceable by laser-marked lot and serial number. Filter lot samples are also tested for water intrusion.
Filter components meet requirements for biological reactivity in vivo under USP <88> for Class VI – 121 °C plastics and in vitro, under USP <87> (Elution Test). This includes the Systemic Toxicity Test, Intracutaneous Test, Implantation Test and the MEM Elution Cytotoxicity test. The filters are made from materials listed for food contact usage per Title 21 of the US Code of Federal Regulations (CFR) Parts 170-199.
Effluent Quality Tests
- Meets with adequate safety margin the current limits under USP <788> Particulate Matter in Injections after flushing, with effluent counts determined microscopically
- Non Fiber-Releasing per Title 21 of the U.S. Code of Federal Regulations (CFR) parts 211.72 and 210.3(b)(6)
- Meets the current USP Oxidizable Substance requirement after flushing, under Sterile Water for Injection, as determined by a potassium permanganate test
- Meets internal specification for pH after flushing when tested in accordance with USP <791>
- Meets internal specifications for pyrogens when an aliquot from a soak solution is tested using the Limulus Amoebocyte Lysate (LAL) reagent
Materials Of Construction
|Membrane||Proprietary, double-layer 0.2 µm hydrophobic polytetrafluoroethylene (PTFE)|
|Support and Drainage Layers||Polyphenylene sulfide|
|Core, Cage, End Caps and Adapters||Polypropylene (high antioxidant formulation with encapsulated stainless steel reinforcing ring for dimensional stability during steam exposure)|
Maximum Differential Pressure1
|Temperature||Forward Direction||Reverse Direction|
|Up to 40 °C||5.4 bard (79 psid)||3.0 bard (43.5 psid)|
|Up to 90 °C||3.4 bard (49 psid)||1.0 bard (14.5 psid)|
Autoclave / Steaming2
|Max. Steaming Conditions 3,4||Pressure and Temperature||Cumulative Steaming Time 3,4|
|Forward||1.0 bard (14.5 psid) at 125 °C||20 h (1 h cycles)|
|0.3 bard (4.4 psid) at 142 °C||100 h (1 h cycles)|
|Reverse||0.5 bard (7.3 psid) at 125 °C||20 h (1 h cycles)|
Typical Service Life in Continuous Flowing Air Service1,5
|Maximum Temperature||Service Life|
|100 °C (212 °F)||12 months|
|110 °C (230 °F)||6 months|
|120 °C (248 °F)||2 months|
Effective Filtration Area6
|127 mm (5 in.) cartridge||0.42 m2 (4.52 ft2)|
|254 mm (10 in.) cartridge||0.84 m2 (9.04 ft2)|
Integrity Test Values7
|Test||Solvent||Gas||Pressure||Limit 5 inch cartridge||Limit 10 inch cartridge|
|Forward Flow||60:40 (v/v) isopropyl alcohol:water||Air||1040 mbar (15 psi)||Maximum 8.0 mL/min||Maximum 16.0 mL/min|
|Water Intrusion||Water||Air||2500 mbar (36 psi)||Maximum 0.16 mL/min||Maximum 0.33 mL/min|
Typical Air Flow
|Air Flow 5-inch cartridge||Vent Condition||1 barg
|100 mbar Differential Pressure||39 Nm3/h||65 Nm3/h||77 Nm3/h||105 Nm3/h|
|Air Flow 10-inch cartridge8||Vent Condition||1 barg
|100 mbar Differential Pressure||90 Nm3/h||130 Nm3/h||160 Nm3/h||220 Nm3/h|
1 For differential pressure and temperature limits in applications with oxygen-enriched air, please refer to Pall application note USTR2311a or contact Pall.
2 The steam life and service life data were determined by testing under controlled laboratory conditions up to the time indicated. Actual operating conditions may affect the filter cartridge’s long-term resistance to steam sterilization and hot air service. Filter cartridges should be qualified for each process.
3 Lab tests to establish multi-cycle resistance. Filters should be qualified in actual use. Contact Pall for recommended procedures.
4 Excursion conditions only.
5 Service life in intermittent air flow service, i.e., venting, may be significantly longer, depending on cumulative time in flowing air and temperature.
6 Values are for one 254 mm (10 in.) filter cartridge and one 127 mm (5 in.) filter cartridge.
7 Values are for one 254 mm (10 in.) cartridge and one 127 mm (5 in.) cartridge at 20 °C (68 °F). Please contact Pall for multi-element integrity test values, different test gas or integrity test solvent.
8 Typical initial clean medium Δp per 254 mm (10 in.) filter cartridge, air at 20 °C. For multi-length cartridges, divide pressure drop by number of 254 mm (10 in.) filter cartridges. Contact Pall for assistance in sizing.
Application Note: USD3087: Safety Considerations for Gas Filtration in High-Temperature and Oxygen Enrichment Applications
Application Note: USTR2330: Sterile Vent Filtration on Ozonated Water Tanks
Application Note: USTR2311: Sterilizing Filtration of Enriched and Pure Gaseous Oxygen Employed in Cell Culture Applications
Certificate of Test (Sample): AB1HTPFR7PVH4
Certificate of Test (Sample): AB1HTPFR7PVJ
Certificate of Test (Sample): AB2HTPFR7PVH4
Certificate of Test (Sample): AB2HTPFR7PVJ
Certificate of Test (Sample): AB3HTPFR7PVH4
Certificate of Test (Sample): AB3HTPFR7PVJ
Certificate of Test (Sample): AB05HTPFR2PVH4
Material Compliance Summary
|Description||Nominal Length||Part Number|
|Emflon HTPFR filter cartridge, double 226 O-ring with bayonet lock, no fin, silicone seal||127 mm (5 inch)||AB05HTPFR2PVH4|
|Emflon HTPFR filter cartridge, double 226 O-ring with bayonet lock and finned cap, silicone seal||254 mm (10 inch)||AB1HTPFR7PVH4|
|Emflon HTPFR filter cartridge, double 226 O-ring with bayonet lock and finned cap, ethylene propylene seal||254 mm (10 inch)||AB1HTPFR7PVJ|
|Emflon HTPFR filter cartridge, double 226 O-ring with bayonet lock and finned cap, silicone seal||508 mm (20 inch)||AB2HTPFR7PVH4|
|Emflon HTPFR filter cartridge, double 226 O-ring with bayonet lock and finned cap, ethylene propylene seal||508 mm (20 inch)||AB2HTPFR7PVJ|
|Emflon HTPFR filter cartridge, double 226 O-ring with bayonet lock and finned cap, silicone seal||762 mm (30 inch)||AB3HTPFR7PVH4|
|Emflon HTPFR filter cartridge, double 226 O-ring with bayonet lock and finned cap, ethylene propylene seal||762 mm (30 inch)||AB3HTPFR7PVJ|