Emflon® CPFR High-temperature Sterilizing-grade Filter Cartridges

Pall Emflon CPFR High-temperature filters have been developed from the long-life and high-strength Emflon PFR filter range. They have been designed and liquid-validated as sterilizing filters for air, gas and vent service in critical high-temperature applications in the BioPharmaceutical and bioprocess industry, like fermentation inlet air, aseptic packaging, or hot WFI tank vents.

The oxidation-resistant components typically allow extended use in air up to a 80 °C (176 °F) and for shorter periods up to 120 °C (248 °F). The high-strength cartridges can also withstand high differential pressures in forward or reverse direction during multiple steam-in-place sterilization cycles. The filters incorporate a double-layer (0.2 µm) of inherently hydrophobic polytetrafluoroethylene (PTFE) membrane, manufactured by Pall. Emflon CPFR filters are identified by their unique colored oxidation resistant components and the easy-to-read laser-etched part number and serial number.

Features and Benefits

Feature:

Validated in accordance with:

• Brevundimonas diminuta in liquid at 107 per cm² according to modified ASTM Standard Test Method F383-83 and FDA Guidelines on Sterile Drug Products Produced by Aseptic Processing (1987)

Benefit:

High validation standards ensure highest removal efficiency and safety margins even in processes with high-temperatures, humid conditions and variable bioburden.

Feature

Correlation of challenge test data with:

• Forward Flow Test and
• Water intrusion test

Benefit

• Allows a safe, easy and fast confirmation of filter integrity for assurance of sterile filtration in critical applications.

Feature

• Lot tests for multi-cycle autoclave challenges

Benefit

• Repeat steamability in situ and robust construction optimized for air, gas and vent service with enhanced life at high-temperatures

Certified P Quality

Emflon CPFR cartridges have been designed and qualified for pharmaceutical use. The provided P Certificate meets and confirms pharmaceutical requirements on the effluent regarding:

Effluent Quality Tests (P Tests)

• Cleanliness per USP Particulates in injectables
• Non Fiber-Releasing
• Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
• Meets oxidizables and pH per USP Sterile Purified Water

Biological Tests

• Meets USP Biological Reactivity Test, in vivo for Class VI-121 °C Plastics

The quality management system for manufacturing of Emflon CPFR occurs in conformance with Certified Quality System ISO 9000.

Each filter is 100% integrity tested and fully traceable by individual laser marked lot and serial number.

Materials of ConstructionMembrane     Double-layer proprietary hydrophobic PTFE

Drainage Layers     Specially developed, resin impregnated polyaramid non-woven material

End Cap, Core and Cage     Pigmented polypropylene

Adapter     Pigmented polypropylene with encapsulated stainless steel reinforcing ring

Nominal Filter AreaAB1CPFR7PVH4     0.72 m² (7.7 ft²)

Maximum Differential PressureMaximum Forward Differential Pressures in Air, Nitrogen or other Compatible Gas Service are:
5.4 bard at 50 °C (80 psid at 122 °F)
4.1 bard at 80 °C (60 psid at 176 °F)
3.4 bard at 90 °C (50 psid at 194 °F)

Maximum Operating Temperature (In Compatible Gases)
120 °C (248 °F)

Maximum Forward Steaming Conditions
1 bard at 125 °C (15 psid at 257 °F)
0.3 bard at 142 °C (4.3 psid at 288 °F)

Maximum Reverse Steaming Conditions
0.5 bard at 125 °C (7.3 psid at 257 °F)
0.2 bard at 142 °C (3.0 psid at 288 °F)

Integrity Test Values⁽¹⁾Forward Flow Test With 60/40 IPA/Water wet (v:v) and air as test gas
14 mL/min at 1040 mbar (15 psi)

Water Intrusion Test     0.3 mL/min at 2500 mbar (36 psi)

¹ Values are for one 10 in. (254 mm) filter at 20 °C (68 °F). Please contact Pall for multi-element integrity test values.

Typical Air Flow at 20 °C (68 °F) and 2 barg (30 psig) Inlet Pressure¹

² Typical initial clean medium ∆p per 254 mm (10 in.) element, air at 20 °C (68 °F). For multipleat cartridges, divide pressure drop by number of 254 mm (10 in.) elements. Contact Pall for assistance in sizing.

Typical Service Life in Continuous Flowing Air Service³

1 year at 100 °C (212 °F)
6 months at 110 °C (230 °F)
2 months at 120 °C (248 °F)

³ For continuous air flow above 60 °C (140 °F), in air/N2 service or other compatible gases, Emflon CPFR filters are recommended. Emflon CPFR can be operated at higher temperatures for longer time periods.

Typical Cumulative Steam Life⁴

100 hours (1-hour cycles) at 140 °C (284 °F)

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’s long-term resistance to steam sterilization and hot air service. Filters should be qualified for each process application.

 

Emflon® CPFR High-temperature Membrane Cartridges

This is a list of typical part numbers for the product described in this catalog.
Click Part Number Configuration to access a PDF of the part numbering structure.
For part numbers and configurations that are that are not listed, please contact your Pall representative.

  Part Number Configuration

AB05CPFR2PVH1	AB05CPFR2PVH4	AB1CPFR7PVH1	AB1CPFR7PVH4
AB1CPFR7PVJ	AB1CPFR8PVH4	AB2CPFR7PVH4	AB2CPFR7PVJ
AB3CPFR7PVH4	AB3CPFR7PVJ

AB05  CPFR  AB1  AB2  AB3
 

CPFR2P  VH1	VH4 AB05CPFR	AB1CPFR	PVH4 AB1CPFR7
PVJ	AB1CPFR8	AB2CPFR7	AB3CPFR7