USD 2159 AVL - Pall Corporation (PLL)

USD 2185 (1)Pall Mustang ® Q CapsulesThe High Throughput Disposable Capsules for ProcessScale Anion Exchange Chromatography

Mustang ® Q Chromatography CapsulesThe High Throughput Disposable Capsules for Process ScaleAnion Exchange ChromatographyPall Mustang Q disposable products are designed to capture negatively chargedbiomolecules in downstream bioprocessing by anion exchange. These productswill be used either for the initial capture of the target biomolecule in a purificationprocess or for the removal of negatively charged contaminants in subsequentpurification steps.Pall's range of Mustang Q disposable capsule filtersDescriptionMustang Q membrane is an innovative newanion exchange support with pendantquaternary amine functional groups in acrosslinked polymeric coating. The 0.8 µmpores in Mustang Q membranes are largeenough to allow large biomolecules toaccess all the binding sites by direct fluidconvection. This produces a very highdynamic capacity for very high molecularweight molecules (i.e DNA, plasmid), or evenparticles as large as viruses. This is incontrast to conventional chromatographicbeads with diffusive pores that typically havemuch lower throughputs and dynamicbinding capacities.Combining this high capacity Q membranewith a unique pleated design resulted in theMustang Q disposable products. EachMustang Q element contains 16 layers ofpleated membrane that will bind negativelycharged biomolecules. These units arespecifically designed to be single use toeliminate cleaning and cleaning validation.They are available in capsules or cartridgeformat to accommodate the entire range ofvolumes used in the biopharmaceuticalprocesses. The 16-layer construction hasbeen held constant from the laboratory"coin" product (0.35 mL) to the industrialscale. The ease of linear scale-up ensures ashortened development time.DNA Removal EfficiencyMustang Q units will typically reduce theDNA level in a solution of sonicated calfthymus DNA from 10 µg/mL to less than10 pg/mL in one pass. This is a removalefficiency of 6 logs. The presence of host cellprotein or other contaminants, and the flowrates used may influence test sensitivity,efficiency of binding and capacity.Performance capability in a specific solutionmust be determined and validated by theuser. For more information, contact Pall.Features and Benefits• Binding efficiency – Positively chargedbiomolecules are readily bound in asingle pass• Speed – High flow rates enable theprocessing of large volumes in less thanone shift• Scalability – A full range of sizesaccommodate different volumes andcapacities needed in biopharmaceuticalprocessing• Convenience – Ready to use andautoclavable• Flexibility – Available in capsule orcartridge format• Cost – Lower operating costs and capitalinvestment compared to conventionalcolumns that need validated packingand cleaningHigh Quality Standards• Manufactured to high quality assurancestandards in accordance with BS ENISO9002; 1997• Membrane lots tested for dynamic proteinbinding capacity, and peak position usingstandard proteins• Identified by a lot number and a uniqueserial number for complete traceability ofmanufacturing history satisfying stringentQC/QA requirements• Supplied with Certificate of Analysisto confirm the quality and quality controlof Pall• Meets USP Biological reactivity tests invivo in accordance with USP Class VI50°C and all materials listed in DrugMaster File submitted to the FDAComprehensive Validation• Extensive validation to ensure consistentand reliable performance• Comprehensive validation guide availableon request

Mustang Q CapsulesTechnical SpecificationsMaterials of ConstructionNovasip TM CapsuleCLxMSTGQP1Kleenpak TM Nova CapsuleNPxMSTGQP1DNA Breakthrough Curves on Mustang Q Capsules0.3Membrane Modified hydrophilic Modified hydrophilicpolyethersulfonepolyethersulfoneMembrane Support and Polypropylene PolypropyleneDrainage Layer AssemblyEndcaps, Core and Cage Polypropylene PolypropyleneHousing Bowl Polyetherimide PolypropyleneAbsorbance 270 nm0.20.1CLM05140µg/mL DNA2.0 liters280 mg DNACL3210µg/mL DNA8.85 liters1.85 g DNANP6338µg/mL DNA22.5 liters7.6 g DNAHousing Head Polyetherimide with TiO 2 Polypropylene with TiO 2O-rings Silicone elastomer Silicone elastomerNote:For CLxMSTQP1, x =M05 for a unit with a bed volume of 10 mL3 for a unit with a bed volume of 60 mLCapsules Operating Characteristics 1Maximum operating pressureMaximum differential pressureMaximum sanitization conditionsMaximum autoclave conditionsFor NPxMSTGQP1, x =6 for a unit with a bed volume of 260 mL7 for a unit with a bed volume of 520 mL8 for a unit with a bed volume of 780 mL3.0 bar (43.5 psi) at 40° C (104°F)3.0 bar (43.5 psi) at 40° C (104°F)1 M NaOH for 30 minutes for one cycle only121°C (250°F) for 30 minutes for one cycle only1With fully compatible fluids that do not soften, swell or adversely affect the capsule or its materials of construction1bar = 100kPa00 5 10 15 20 25Breakthrough Volume (liters)DNA breakthrough curves above demonstrate the high breakthroughcapacity of Mustang Q capsules. After preconditioningand equilibration with 25mM Tris-HCl pH 8.0, a solution of140 µg/mL, 210 µg/mL and 338 µg/mL of herring sperm DNA in25mM Tris-HCl pH8.0 was pumped respectively through the10 mL, 60 m/L and 260 mL capsules at a flow rate of 10-20CV/min. The absorbance at 260 nm was continuously monitoreddownstream of the capsule.Scaling Down Unit CharacteristicsMaterials of ConstructionMembraneModified hydrophilic polyethersulfoneAvailable Sizes and Typical Dynamic Binding CapacityPart number Bed volume Typical BSA Flow rate(mL) binding capacity (mg) (L/min/bar Delta P) (2)MSTG18Q16 0.35 17 6.4 mL/min (0.43 mL/min/psi)CLM05MQTGSP1 10 500 0.245 (17 mL/min/psi)CL3MSTGQP1 60 3,000 1.25 (86 mL/min/psi)NP6MSTGQP1/ 260 13,000 3.9 (269 mL/min/psi)AB1MSTGQ7PH4NP7MSTGQP1/ 520 26,000 7.8 (538 mL/min/psi)AB2MSTGQ7PH4NP8MSTGQP1/ 780 39,000 11.7 (807 mL/min/psi)AB3MSTGQ7PH4HousingSupport fritHousing clampO-ringsNominal DimensionsCoin deviceHousingFittingsOperating CharacteristicsMaximum temperature316L stainless steel316B stainless steel300 series stainless steel housingSilicone elastomer18 mm outer diameter51 mm heightM6 male to 1 ⁄16"OD tubing andM6 male to luer lock female fittings40° C (104°F)(2)For liquid of 1 cP. For other liquids divide the flow rate by the viscosity expressed in cP.Maximumdifferential pressure17 bar (246.5 psi)Nominal Dimensions for CapsulesCapsule type CLM05MSTGQP1 CL3MSTGQP1 NP6MPSTGQP1 NP7MSTGQP1 NP8MSTGQP1Maximum Diameter Including Valves 123 mm 123 mm 154 mm 154 mm 154 mm(4.8 in.) (4.8 in.) (6.1 in.) (6.1 in.) (6.1 in.)Length with 38 mm (1 1 ⁄2") 84 mm 157 mm 333 mm 581 mm 831 mmSanitary Flange (3.3 in.) (6.2 in.) (13.1 in.) (22.9 in.) (32.7 in.)Bed Volume (mL) 10 60 260 520 780

Ordering InformationPart number Product description PackagingMSTG18Q16 Mustang Q coin 10/boxMSTG18H16 Stainless steel coin housing assembly 1/boxMSTG18H16F Mustang coin housing frits 2 frits/boxMSTG18H16G Mustang coin housing gaskets 2 gaskets/boxCLM05MSTGQP1 Mustang Q capsule, 10mL, connections 1" / 1 1 /2" compatible Tri-Clamp 1/boxCL3MSTGQP1 Mustang Q capsule, 60mL, connections 1" / 1 1 /2" compatible Tri-Clamp 1/boxNP6MSTGQP1 Mustang Q capsule, 260mL, connections 1" / 1 1 /2" compatible Tri-Clamp 1/boxNP7MSTGQP1 Mustang Q capsule, 520mL, connections 1" / 1 1 /2" compatible Tri-Clamp 1/boxNP8MSTGQP1 Mustang Q capsule, 780mL, connections 1" / 1 1 /2" compatible Tri-Clamp 1/boxAB1MSTGQ7PH4 Mustang Q cartridge, 260mL, code 7 1/boxAB2MSTGQ7PH4 Mustang Q cartridge, 520mL, code 7 1/boxAB3MSTGQ7PH4 Mustang Q cartridge, 780mL, code 7 1/boxFor more information, contact PallPall has the most comprehensivefamily of scaleable separation products.2200 Northern BoulevardEast Hills, New York 11548-1289+1 800.717.7255 toll free+1 516.484.5400 phone+1 516.801.9548 faxpharmafilter@pall.com e-mailVisit us on the web at www.pall.com /biopharmaceuticalPall Corporation has offices and plants throughout the world in locations including:Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands,New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa, Sweden,Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.Distributors are located in all major industrial areas of the world.Europa House, Havant StreetPortsmouth PO1 3PD, United Kingdom+44 (0)23 9230 3303 phone+44 (0)23 9230 2506 faxBioPharmUK@europe.pall.com e-mail, Pall, Mustang, Kleenpak and Novasip are trademarks of Pall Corporation.Tri-Clamp is a trademark of Alfa Laval.Filtration, Separation, Solution and UpScale are service marks of Pall Corporation.® indicates a Pall trademark registered in the USA.© Copyright 2004 Pall Europe Ltd.PELEH/02-W.SH/CS/09.2004