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.
