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PALL EMFLON II AB1V0027PVH4 FILTER 0.2 MICRON AB-STYLE CARTRIDGE. NEW UNUSED SURPLUS INVENTORY. NEW UNUSED SURPLUS INVENTORY. SELLING AS-IS. NO RETURNS! Pall®: EMFLON® II GAS FILTERRated: 0.2 µmPart Number: AB1V0027PVH4 was manufactured in a controlled environment andsubjected to a high velocity flush after undergoing integritytesting. The 0.2 µm filter membrane used in the filterelement has a quantitative bubble point (i.e. "KL") whichmet or exceeded 1100 mbar (16.0 psi) in isopropyl alcohol.These filters are not supplied sterile.Fabrication IntegrityEach filter element in this lot successfully passed amanufacturing Forward Flow test. The user Forward Flowlimit for this product is 4.00 ml/minute using air at a testpressure of 830 mbar (12.00 psig) when fully wetted with25:75 (v/v) tertiary butanol:water. The Forward Flow testlimit has been validated for bacterial removal by correlationof the above parameters with microbiological challengetest. Recommended test values for integrity testing of Pallfilters as installed must be obtained from Pall. Samplesfrom this manufacturing lot also maintained integrity aftermultiple autoclave cycles.Bacterial RetentionFinished product has been sampled and successfullytested for retention of Brevundimonas diminuta (ATCC19146), using procedures described in Pall ValidationGuides and ASTM Standard Test Method F838-15, inconformance with the applicable requirements of the FDAGuideline Sterile Drug Products Produced by AsepticProcessing - Current Good Manufacturing Practice(September 2004).Materials of ConstructionRepresentative filter components have met therequirements for biological reactivity, in vivo , under USP (for Class VI - 121°C plastics).The filters also are manufactured from materials listed inTitle 21 of the U.S. Code of Federal Regulations (CFR),parts 170-199. Contact Pall for further informationregarding materials of construction.This product does not contain materials of constructionthat are considered specified TSE or BSE risk materialsaccording to current legislation and guidelines (referenceEuropean CPMP EMA/410/01 and Title 21 of the U.S.Code of Federal Regulations, Part 189.5).Effluent QualityFilter samples from this manufacturing lot underwent thefollowing tests and the lot was released by QualityControl when it was verified that their respective criteriawere met:Cleanliness: Meets with adequate safety margin afterflushing, current limits under USP ParticulateMatter in Injections, with effluent counts determinedmicroscopically. Counts serve to documentconformance with the requirements for anon-fiber-releasing filter per Title 21 of the U.S. Code ofFederal Regulations (CFR) parts 211.72 and 210.3 (b)(6).Oxidizable Substances: Meets the current USPrequirement, after flushing under Sterile Purified Water,as determined by a Potassium Permanganate test.pH: Meets internal specifications after flushing, upstreamversus downstream differential not to exceed +/- 0.5 pHunits, when tested in accordance with USP pH.Endotoxins: Meets current requirements under USPWater for Injection, 0.25 EU/ml, when an aliquot from asoak solution is tested using Limulus AmoebocyteLysate (LAL) reagent in accordance with USP Bacterial Endotoxins Test.