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Emflon PFR Sterile Air Filter Overview

The document details the Pall Emflon® PFR sterile air filter cartridges, which utilize advanced 0.2µm PTFE double layer membranes to effectively remove bacteria, viruses, and particles from air and gas streams. It outlines specifications, including materials, operating conditions, removal ratings, and typical service life, as well as compliance with FDA and USP standards. The filters are designed for various applications, including sterile process air and venting, and are manufactured under cGMP with a certificate of test provided.

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0% found this document useful (0 votes)
37 views2 pages

Emflon PFR Sterile Air Filter Overview

The document details the Pall Emflon® PFR sterile air filter cartridges, which utilize advanced 0.2µm PTFE double layer membranes to effectively remove bacteria, viruses, and particles from air and gas streams. It outlines specifications, including materials, operating conditions, removal ratings, and typical service life, as well as compliance with FDA and USP standards. The filters are designed for various applications, including sterile process air and venting, and are manufactured under cGMP with a certificate of test provided.

Uploaded by

Dandelo King
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Air/Gas Service Products

NEW Emflon® PFR Sterile Air Membrane Cartridges

Description Specifications
Pall Emflon® PFR sterile air filter car- Materials Operating Conditions
tridges feature Pall’s advanced 0.2µm • FDA-listed materials per 21-CFR Max. Differential Pressure/Temp.: 5
polytetrafluoroethylene (PTFE) double • Membranes: double layer PTFE • 77 psid (5.3 bar) at 68°F (20°C)
layer membranes. They are designed to • Support/Drainage: Polypropylene, • 60 psid (4.1 bar) to 176°F (80°C)
completely remove bacteria, viruses and oxidation resistant Typical Continuous Air Service Life: 6
particles from air and gas streams, even • Core/Cage/End Caps/Adapters: • 12 months to 166°F (60°C)
Air/Gas Service Products

in the presence of humidity and moisture. Polypropylene, oxidation resistant Typical Vent Service Life:
Pleat-ed with very high area into sanitary • Code 7/2 adapters with encapsulated • 6 months to 176°F (80°C)
single open ended (SOE) AB style car- stainless steel reinforcing ring
Autoclave/Steaming
tridges, Emflon PFR filters are built to • O-rings: silicone 1
• Cumulative Steaming Time: 7
withstand adverse in situ steaming condi-
Removal Ratings 165 hrs (1hr cycles) to 289°F (140°C)
tions in either the forward or reverse
Air/Gases: <0.003 µm, particulate 2 • Max. Forward Steaming Conditions:
direction. Suitable applications are fer-
Liquids: 0.2 µm, sterilizing 3 14.5 psid (1.0 bard) at 257°F (125°C)
menter inlet air and exhaust venting, ster-
4.4 psid (0.3 bard) at 289°F (142°C)
ile process air, and sterile venting of Configurations (AB Code 7) 4
• Max. Reverse Steaming Conditions:
tanks, lyophilizers and autoclaves. • Single open ended
7.3 psid (0.5 bard) at 257°F (125°C)
• Double 226 O-ring adapter
• Pall PTFE membranes 3.0 psid (0.2 bard) at 289°F (142°C)
• Finned end, bayonet lock.
• Inherently hydrophobic
Aqueous Extractables (20°C)
• Double layer for added assurance Dimensions (nominal)
• <5 mg per 10 in. (254 mm) element
Liquid Service Products

• High flow/low pressure drop • Lengths: 5 in. (127 mm), 10 in. (254 mm),
after 1 hour steam at 257°F (125°C)
• 100% bacteria retentive in liquids 20 in. (508 mm), 30 in. (762 mm),
• 100% virus retentive in gases 40 in. (1016 mm)
• Melt-sealed construction • Diameter: 2.75 in. (70 mm)
• Enhanced steaming resistance
Filter Area (nominal)
• 100% Forward Flow tested
• 8.6 ft 2 (0.8 m 2) per 10 in. (254 mm)
• Water intrusion testable
element
• Individually serialized
• 4.1 ft 2 (0.4 m 2) per 5 in. (127 mm)
• Manufactured for use in conformance
element
with cGMP
• ISO 9000 Certified Quality System
• Pharmaceutical “P” optimized
Air/Gas Service Products

• Certificate of Test provided


• Validation Guide available
Quality/Bio-Safety Integrity Test Values 1 Other polymers available.
2 By NaCl CNC particle analysis. Also retains 100%
Biological Tests: Per 10 in. (254 mm) Cartridge: 9 of Brevundimonas diminuta bacteria, bacterio-
• Meets USP Biological Reactivity, • Forward Flow (air test gas): phage and virus aerosols.
3 Lot samples of assemblies retain >10 7 cfu/cm 2 of
In Vivo, for Class VI-121°C plastics. 60:40 IPA:Water wet (v:v) Brevundimonas diminuta in liquid per mod. ASTM
Effluent Quality Tests: 8 ≤15 cc/min at 15 psi (1035 mbar) F838-83 and FDA guidelines.
4 AB05 style is Code 2 flat end. Other adapter
• Meets Cleanliness per USP • Water Intrusion: codes available.
Particulates in Injectables. ≤0.33 cc/min at 36 psi (2485 mbar) 5 In air/N 2 service or other compatible gases.
6 For continuous air flow above 60°C, Emflon CFR
• Non-Fiber-Releasing per 21CFR filters are recommended. Emflon PFR can be
operated at higher temperatures for shorter time
• Non-Pyrogenic per USP periods.
Bacterial Endotoxins (<0.25 EU/ml). 7 Lab tests to establish multi-cycle resistance.
Filters should be qualified in actual use. Contact
• Meets Oxidizables and pH per USP Pall for recommended procedures.
packaged waters. 8 Per lot sample soak or rinse-up flush aliquots.
9 Contact Pall for multi-element values.
Steam Resistance: Lot samples multi- AB05PFR value is 7.8 cc/min.
cycle autoclave challenged.

Pressure Drop vs. Air Flow Rates 10 Part Numbers / Ordering Information
Part Nominal AB Style
3
Number11 Length Code 12
Air Flow Rate (Nm /h) at Ambient Temperature
0 80 160 240 320 AB05PFR2PVH4 5 in. (127 mm) 2
4
Vent 250 AB1PFR7PVH4 10 in. (254 mm) 7

3 AB2PFR7PVH4 20 in. (508 mm) 7


200
Clean Pressure Drop (mbar)
Clean Pressure Drop (psid)

AB3PFR7PVH4 30 in. (762 mm) 7


2 30psig 150
AB4PFR7PVH4 40 in. (1016 mm) 7
100

Air/Gas Service Products


1 60psig
50

0 0
0 50 100 150 200
Air Flow Rate (scfm) at Ambient Temperature
10 Typical initial clean medium ∆P per 10 in. (254 mm) element, air at 68°F (20°C). 11 P at end of part number indicates optimized and qualified for Pharmaceutical
For multi-element cartridges, divide pressure drop by number of 10 in. (254 mm) use including encapsulated stainless steel reinforcing adapter ring for steaming
elements. Non-linear cartridge turbulence factors are incorporated into housing in situ, 100% integrity testing and Certificate of Test provided. V indicates
pressure drop values. For complete assembly pressure drop, add filter cartridge optimized for vent/air/gas service. H4 suffix=Silicone O-rings (standard).
medium value to housing value at specified flow rate. For gases other than air or See Appendix for available alternate O-ring polymers and codes.
nitrogen, contact your local Pall distributor. 12 AB05 standard with Code 2 flat cap, other lengths Code 7 with finned cap.
Both with double 226 O-rings. See Appendix for adapter dimensions and alter-
Note: Curve labels denote inlet pressures. nate codes.

Note: For sizing filters or other information, please contact your local Pall
distributor.

Specifications and Availability: The information provided is a guide to the part

Liquid Service Products


number structure and possible options. Product availability may be subject to
change without notice. All specifications are nominal. This literature was reviewed
for accuracy at the time of publication. For current information on the products and
test methodologies, consult your local Pall distributor.

Air/Gas Service Products

© Copyright 2002, Pall Corporation. Pall, are trademarks of Pall Corporation. ® Indicates a Pall trademark
registered in the USA. is a service mark of Pall Corporation.

For information or to order, call 1.800.717.7255 or 516.484.5400 / fax 516.625.3610 / [Link]

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