emflon htpfr filter cartridges - donar.messe.de
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USD 2860a
Unrivalled hot air filter for long life and easy waterintrusion testing
Emflon® HTPFR Filter Cartridges
Features BenefitsDesigned for Water Intrusion Test (WIT) No alcohol required
Oxidation-resistant materials of construction Long service life in hot air and vent applications; also suitable for oxygen-enriched fermenter applications(see Pall publication USTR2311a)
Proprietary, Pall-manufactured PTFE membrane Hydrophobic membrane, subject to rigorous Pallmanufacturing and quality controls; secure supply source
Validated with B. diminuta at >107 cfu/cm2 Provides sterile air/gas under wet and dry conditions, meets cGMP sterilizing-grade filter requirements
Fully validated under stringent microbial, phage and particulate challenge tests
Improves microbial safety; mitigates virus contamination risk
Designed for multi-cycle autoclave and in situ steam Robust construction offers enhanced steam resistance
High flow rates, low pressure drops Allows smaller filtration systems, reducing installationand operational costs
Laser-etched part/serial number and 2D matrix code Easily traceable; product information easily read or scanned with a barcode reader
2
DescriptionEmflon HTPFR filter cartridges are specifically designed for thesterile filtration of air, gas and vent service in critical, high-temperature and ozonated-water venting applications. They canalso be considered for use in oxygen-enriched air applications in the biopharmaceutical and biotechnology industries (see Pallpublication USTR2311a). High-temperature applications includeautoclave, fermentation inlet air, aseptic packaging/blow-fill-sealand hot Water For Injection (WFI) tank vents. These filtersincorporate a double-layer (0.2 µm) of inherently hydrophobic,Pall-manufactured polytetrafluoroethylene (PTFE) membrane.The polypropylene hardware is specially formulated withprotective anti-oxidants and the filter’s support and drainagelayers are made of poly phenyl sulphide polymer. Oxidation-resistant filter components allow extended use in air/vent service up to 100 °C and for shorter periods up to 120 °C.
Certified For Pharmaceutical UseEmflon HTPFR filter cartridges are qualified for use inpharmaceutical GMP manufacturing. Each filter is supplied with aCertificate of Test confirming pharmaceutical industry requirementsfor fabrication integrity, effluent quality and biological safety testing.Pall filters are manufactured in a controlled environment under aquality management system certified to ISO9001:2008. All HTPFRcartridges 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 andserial number. Filter lot samples are also tested for water intrusion.
Figure 1Emflon HTPFR cartridge being scanned with a Palltronicbarcode reader and connected to a Palltronic Flowstar IVintegrity test instrument
Filter components meet requirements for biological reactivity in vivo under USP <88> for Class VI – 121 °C plastics and invitro, under USP <87> (Elution Test). This includes the SystemicToxicity Test, Intracutaneous Test, Implantation Test and the MEMElution Cytotoxicity Test. The filters are made from materials listedfor food contact usage per Title 21 of the US Code of FederalRegulations (CFR) Parts 170-199.
Effluent Quality TestsMeets with adequate safety margin the current limits underUSP <788> Particulate Matter in Injections after flushing, with effluent counts determined microscopically
Non Fiber-Releasing per Title 21 of the U.S. Code of FederalRegulations (CFR) parts 211.72 and 210.3(b)(6)
Meets the current USP Oxidizable Substance requirementafter flushing, under Sterile Water for Injection, as determinedby a potassium permanganate test
Meets internal specification for pH after flushing when testedin accordance with USP <791>
Meets internal specifications for pyrogens when an aliquot from a soak solution is tested using the Limulus AmoebocyteLysate (LAL) reagent in accordance with USP <85> BacterialEndotoxins Test
SpecificationsMaterials of Construction
Membrane Proprietary, double-layer 0.2 µmhydrophobic polytetrafluoroethylene(PTFE)
Support and Drainage Layers Polyphenylenesulphide (PPS)
Core, Cage, End Caps Adapters Polypropylene (high antioxidantformulation with encapsulated polymericreinforcing ring for dimensional stabilityduring steam exposure)
Maximum Differential Pressure1
Temperature Forward Direction Reverse DirectionUp to 40 °C (104 °F) 5.4 bar (79 psi) 3.0 bar (43.5 psi)Up to 90 °C (194 °F) 3.4 bar (49 psi) 1.0 bar (14.5 psi)Steam up to 125 °C(257 °F)
1.0 bar (14.5 psi) 0.5 bar (7.3 psi)
Steam up to 142 °C(288 °F)
0.3 bar (4.4 psi) 0.2 bar (2.9 psi)
www.pall.com 3
Figure 2Typical Air Flow at 20 °C for the 5 inch cartridge
Figure 3Typical Air Flow6 at 20 °C for the 10 inch cartridge
Ordering Information7
1 For differential pressure and temperature limits in applications withoxygen-enriched air, please refer to Pall publication USTR2311a or contact Pall
2 Service life in intermittent air flow service, i.e. venting, may besignificantly longer, depending on cumulative time in flowing air and temperature
3 Values are for one 254 mm (10 in.) filter cartridge and one 127 mm (5 in.) filter cartridge
4 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-termresistance to steam sterilization and hot air service. Filter cartridgesshould be qualified for each process
5 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 integritytest values, different test gas or integrity test solvent
6 Typical initial clean medium ∆p per 254 mm (10 in.) filter cartridge, air at 20 °C. For multi-length cartridges, divide pressure drop bynumber of 254 mm (10 in.) filter cartridges. Contact Pall for assistance in sizing
7 This is a guide to the part number structure only. For availability of specific options please contact Pall
Typical Service Life in Continuous Flowing Air Service1, 2
Maximum Temperature Service Life100 °C (212 °F) 12 months110 °C (230 °F) 6 months120 °C (248 °F) 2 months
Effective Filtration Area3
5 inch cartridge 0.42 m2 (4.52 ft2)10 inch cartridge 0.814 m2 (9.04 ft2)
Description Length (Nominal) Part Number
Emflon HTPFR filter cartridge,double 226 O-ring with bayonetlock, no fin, silicone seal
127 mm (5 inch) AB05HTPFR2PVH4
Emflon HTPFR filter cartridge,double 226 O-ring with bayonetlock and finned cap, silicone seal
254 mm (10 inch) AB1HTPFR7PVH4
Emflon HTPFR filter cartridge,double 226 O-ring with bayonetlock and finned cap, ethylenepropylene seal
254 mm (10 inch) AB1HTPFR7PVJ
Emflon HTPFR filter cartridge,double 226 O-ring with bayonetlock and finned cap, silicone seal
508 mm (20 inch) AB2HTPFR7PVH4
Emflon HTPFR filter cartridge,double 226 O-ring with bayonetlock and finned cap, ethylenepropylene seal
508 mm (20 inch) AB2HTPFR7PVJ
Emflon HTPFR filter cartridge,double 226 O-ring with bayonetlock and finned cap, silicone seal
762 mm (30 inch) AB3HTPFR7PVH4
Emflon HTPFR filter cartridge,double 226 O-ring with bayonetlock and finned cap, ethylenepropylene seal
762 mm (30 inch) AB3HTPFR7PVJ
0 50 100 150 200 250 300 350 400
600550500450400350300250200150100
500
Air Flow Rate (Nm3/h)
dp
(psi
)
dp
(mb
ar)
AB05HTPFR Air Flow / dp (Housing Losses Subtracted)Air Flow Rate (SCFM)
0 50 100 150 200
8
7
6
5
4
3
2
1
0
Vent1 barg
2 barg4 barg 1, 2, & 4 barg are inlet pressures
0 50 100 150 200 250 300 350 400
600550500450400350300250200150100
500
Air Flow Rate (Nm3/h)
dp
(psi
)
dp
(mb
ar)
AB1HTPFR Air Flow / dp (Housing Losses Subtracted)Air Flow Rate (SCFM)
0 50 100 150 200
8
7
6
5
4
3
2
1
0
Vent1 barg
2 barg4 barg 1, 2, & 4 barg are inlet pressures
Typical Cumulative Steam Life4
100 hours (1-hour cycles) at 142 °C (288 °F)
Integrity Test Values5
Test Solvent Gas Pressure
Limit5 inchCartridge
Limit10 inchCartridge
ForwardFlow
60:40 (v/v)isopropylalcohol:water
Air 15 psi (1040 mbar)
Maximum 8.0 mL/min
Maximum 16.0 mL/min
WaterIntrusion
Water Air 36 psi (2500 mbar)
Maximum0.16 mL/min
Maximum0.33 mL/min
Corporate HeadquartersPort Washington, NY, USA+1.800.717.7255 toll free (USA)+1.516.484.5400 phonebiopharm@pall.com e-mail
European HeadquartersFribourg, Switzerland+41 (0)26 350 53 00 phoneLifeSciences.EU@pall.com e-mail
Asia-Pacific HeadquartersSingapore+65 6389 6500 phonesgcustomerservice@pall.com e-mail
International OfficesPall Corporation has offices and plants throughout the world in locations such as:Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela.Distributors in all major industrial areas of the world. To locate the Pall office or distributornearest you, visit www.pall.com/contact.
The information provided in this literature was reviewed for accuracy at the time ofpublication. Product data may be subject to change without notice. For currentinformation consult your local Pall distributor or contact Pall directly.
© 2013, Pall Corporation. Pall, , Emflon and Palltronic are trademarks of Pall Corporation. ® indicates a trademark registered in the USA and TM indicates an unregistered mark. ENABLING A GREENER FUTURE and Filtration. Separation. Solution.are service marks of Pall Corporation.
05/13, PDF, GN13.5729 USD 2860a
Visit us on the Web at www.pall.com/biopharmE-mail us at biopharm@pall.com
To see how Pall is helping enable a greener, safer and more sustainablefuture, visit www.pall.com/green.
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