Emflon® PFR Sterile Air Membrane Cartridges

Description

Emflon® PFR filters have been developed from the successful Emflon filter range launched in 1981 and widely used as air and gas sterilizing filters in the pharmaceutical and biotechnology industries. The double layer PTFE membrane is inherently hydrophobic, chemically inert and designed specifically for removal of contaminating bacteria and viruses. Emflon PFR filters meet the ever increasing demand for air filters with greater strength, longer life and the ability to withstand the rigours of in-situ steaming in the forward or reverse direction.

Emflon PFR filters provide high assurance of filter integrity and long life, even during continuous use in hot air up to 60°C, in vent applications up to 80°C and during repeated steaming. The filters can withstand up to 1 bar (14.5 psi) differential pressure (forward direction) under steam sterilization conditions (125°C). This is combined with high flow rates and excellent dewetting characteristics resulting in very economical filtration through the use of smaller installations and reduced energy costs. In addition, the filters can be tested in-situ by the Forward Flow integrity test or by a Water Intrusion test. Both tests are correlated to liquid bacterial challenge - the ‘worst case’ challenge.

Scientific Validation

Emflon PFR filters have been extensively and scientifically validated using the most advanced methods and the most sensitive equipment available. They have an absolute removal rating of 0.2 µm in liquids and 0.003µm in gases and have been validated by:

• Brevundimonas (Pseudomonas) diminuta liquid challenge at 10⁷/cm²
• Brevundimonas (Pseudomonas) diminuta aerosol challenge
• PP7 bacteriophage aerosol challenge
• Airborne sodium chloride aerosol challenge at 100 l/min flow (0.003 µm rated in gases).

Features and Benefits

Comprehensive validation assures highest removal efficiency and highest safety margins. High flow rates and low pressure drop allow use of small systems, reducing installation and running costs. Robust construction ensures integrity and reliability. Long steaming life and long service offer low cost filtration.

Materials

• FDA-listed materials per 21-CFR
• Membranes: double layer PTFE
• Support/Drainage: Polypropylene, oxidation resistant
• Core/Cage/End Caps/Adapters: Polypropylene, oxidation resistant
• Code 7/2 adapters with encapsulated stainless steel reinforcing ring
• O-rings: silicone ¹

Removal Ratings

Air/Gases: <0.003 µm, particulate ²
Liquids: 0.2 µm, sterilizing ³

Configurations (AB Code 7)⁴

• Single open ended
• Double 226 O-ring adapter
• Finned end, bayonet lock.

Dimensions (nominal)

• Lengths: 5 in. (127 mm), 10 in. (254 mm), 20 in. (508 mm), 30 in. (762 mm), 40 in. (1016 mm)
• Diameter: 2.75 in. (70 mm)

Filter Area (nominal)

• 8.6 ft² (0.8 m²) per 10 in. (254 mm) element
• 4.1 ft² (0.4 m²) per 5 in. (127 mm) element

Operating Conditions

Max. Differential Pressure/Temp:⁵

• 77 psid (5.3 bar) at 68°F (20°C)
• 60 psid (4.1 bar) to 176°F (80°C)

Typical Continuous Air Service Life:⁶

• 12 months to 166°F (60°C)

Typical Vent Service Life:

• 6 months to 176°F (80°C)

Autoclave/Steaming

• Cumulative Steaming Time:⁷ 165 hrs (1hr cycles) to 289°F (140°C)
• Max. Forward Steaming Conditions:
  14.5 psid (1.0 bard) at 257°F (125°C)
  4.4 psid (0.3 bard) at 289°F (142°C)
• Max. Reverse Steaming Conditions:
  7.3 psid (0.5 bard) at 257°F (125°C)
  3.0 psid (0.2 bard) at 289°F (142°C)

Aqueous Extractables (20°C)

• <5 mg per 10 in. (254 mm) element after 1 hour steam at 257°F (125°C)

Quality/Bio-Safety

Biological Tests:

• Meets USP Biological Reactivity, In Vivo, for Class VI-121°C plastics.

Effluent Quality Tests: ⁸

• Meets Cleanliness per USP Particulates in Injectables.
• Non-Fiber-Releasing per 21CFR
• Non-Pyrogenic per USP Bacterial Endotoxins (<0.25 EU/ml).
• Meets Oxidizables and pH per USP packaged waters.

Steam Resistance: Lot samples multicycle autoclave challenged.

Integrity Test Values

Per 10 in. (254 mm) Cartridge: ⁹

• Forward Flow (air test gas):
  60:40 IPA:Water wet (v:v)  15 cc/min at 15 psi (1035 mbar)
• Water Intrusion:  0.33 cc/min at 36 psi (2485 mbar)

 

¹ Other polymers available.

² By NaCl CNC particle analysis. Also retains 100% of Brevundimonas diminuta bacteria, bacteriophage and virus aerosols.

 

³ Lot samples of assemblies retain >107 cfu/cm2 of Brevundimonas diminuta in liquid per mod. ASTM F838-83 and FDA guidelines.

 

⁴ AB05 style is Code 2 flat end. Other adapter codes available.

⁵ In air/N2 service or other compatible gases.

⁶ For continuous air flow above 60°C, Emflon CPFR filters are recommended. Emflon PFR can be operated at higher temperatures for shorter time periods.

⁷ Lab tests to establish multi-cycle resistance. Filters should be qualified in actual use. Contact Pall for recommended procedures.

⁸ Per lot sample soak or rinse-up flush aliquots.

⁹ Contact Pall for multi-element values. AB05PFR value is 7.8 cc/min.

Pressure Drop vs. Air Flow Rates ¹⁰

 

¹⁰ Typical initial clean medium P per 10 in. (254 mm) element, air at 68°F (20°C). For multi-element cartridges, divide pressure drop by number of 10 in. (254 mm) elements. Non-linear cartridge turbulence factors are incorporated into housing pressure drop values. For complete assembly pressure drop, add filter cartridge medium value to housing value at specified flow rate. For gases other than air or nitrogen, contact your local Pall distributor.

 

Note: Curve labels denote inlet pressures.

Part Numbers / Ordering Information

Part Number11	Nominal Length	AB Style Code12
AB05PFR2PVH4	5 in. (127 mm)	2
AB1PFR7PVH4	10 in. (254 mm)	7
AB2PFR7PVH4	20 in. (508 mm)	7
AB3PFR7PVH4	30 in. (762 mm)	7
AB4PFR7PVH4	40 in. (1016 mm)	7

 

¹¹ P at end of part number indicates optimized and qualified for Pharmaceutical use including encapsulated stainless steel reinforcing adapter ring for steaming in situ, 100% integrity testing and Certificate of Test provided. V indicates optimized for vent/air/gas service. H4 suffix=Silicone O-rings (standard). See Appendix for available alternate O-ring polymers and codes.

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 alternate 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 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.