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, such as 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 and for shorter periods up to 120 °C. 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 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 Construction

Membrane	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 Area

AB1CPFR7PVH4	0.72 m2 (7.7 ft2)

 

Operating Parameters

Maximum Forward Differential Pressures in Air, Nitrogen or other Compatible Gas Service are:	5.4 bard (80 psid) at 50 °C 4.1 bard (60 psid) at 80 °C 3.4 bard (50 psid) at 90 °C
Maximum Operating Temperature (In Compatible Gases)	120 °C
Maximum Forward Steaming Conditions	1 bard (15 psid) at 125 °C 0.3 bard (4.3 psid) at 142 °C
Maximum Reverse Steaming Conditions	0.5 bard (7.3 psid) at 125 °C 0.2 bard (3.0 psid) at 142 °C

 

Integrity Test Values¹

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 254mm (10 in.) filter at 20 °C. Please contact Pall for multi-element integrity test values.

 

Typical Air Flow at 20 °C and 2 barg (30 psig) Inlet Pressure ²

² Typical initial clean medium ∆p per 254 mm (10 in.) element, air at 20 °C. For multilength 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 Service ³

1 year at 100 °C

6 months at 110 °C

2 months at 120 °C

³ For continuous air flow above 60 °C, 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 Life ⁴

100 hours (1-hour cycles) at 140 °C

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.