Pall™ Emflon™ HTPFR sterile air filter cartridges

Features

• Designed for Water Intrusion Test (WIT)
• Oxidation-resistant materials of construction
• Proprietary PTFE membrane
• Validated with B. diminuta at >10⁷ cfu/cm²
• Fully validated under stringent microbial, phage and particulate challenge tests
• Designed for multi-cycle autoclave and in situ steam
• High flow rates, low pressure drops
• Laser-etched part/serial number and 2D matrix code

Benefits

• No alcohol required
• Long service life in hot air and vent applications; also suitable for oxygen-enriched fermenter applications (see publication USTR2311a)
• Hydrophobic membrane, subject to rigorous manufacturing and quality controls; secure supply source
• Provides sterile air/gas under wet and dry conditions, meets cGMP sterilizing-grade filter requirements
• Improves microbial safety; mitigates virus contamination risk
• Robust construction offers enhanced steam resistance
• Allows smaller filtration systems, reducing installation and operational costs
• Easily traceable; product information easily read or scanned with a barcode reader (e.g. the Palltronic® barcode reader)

Certified For Pharmaceutical Use

Emflon™ HTPFR filter cartridges are qualified for use in pharmaceutical GMP manufacturing. Each filter is supplied with a Certificate of Test confirming pharmaceutical industry requirements for fabrication integrity, effluent quality and biological safety testing. Filters are manufactured in a controlled environment under a quality management system certified to ISO9001:2008. All Emflon HTPFR cartridges are Forward Flow integrity-tested in manufacturing, correlated to bacterial retention in liquids and bacteriophage (virus) retention in air, and are fully traceable by laser-marked lot and serial number. Filter lot samples are also tested for water intrusion.

Filter components meet requirements for biological reactivity in vivo under USP <88> for Class VI – 121°C plastics and in vitro, under USP <87> (Elution Test). This includes the Systemic Toxicity Test, Intracutaneous Test, Implantation Test and the MEM Elution Cytotoxicity test. The filters are made from materials listed for food contact usage per Title 21 of the US Code of Federal Regulations (CFR) Parts 170-199.

Effluent Quality Tests

• Meets with adequate safety margin the current limits under USP <788> Particulate Matter in Injections after flushing, with effluent counts determined microscopically
• Non Fiber-Releasing per Title 21 of the U.S. Code of Federal Regulations (CFR) parts 211.72 and 210.3(b)(6)
• Meets the current USP Oxidizable Substance requirement after flushing, under Sterile Water for Injection, as determined by a potassium permanganate test
• Meets internal specification for pH after flushing when tested in accordance with USP <791>
• Meets internal specifications for pyrogens when an aliquot from a soak solution is tested using the Limulus Amoebocyte Lysate (LAL) reagent

Palltronic® is a trademark of Pall Corporation. ® indicates a trademark registered in the USA. Any other third-party trademarks are the property of their respective owners.