EOY)aa76 9:48$cGGG[P, !0n``YaP 0A ePPIP/eH81c Evenness of torque is critical to system performance. The compression is supplied by applying torque to the nuts on the threaded tie-rods of the holder assembly. 0000474982 00000 n ensure that the cassettes will seal properly. 0000442609 00000 n Pellicon XL 50 Ultrafiltration Cassettes - EMD Millipore This P3C030C05 Pellicon 3 ultrafiltration device features a pore size of 30 kDa NMWCO, a filtration area of 0.57 m 2, a PLCTK membrane, and dimensions . When the wrench clicks, this indicates that the set force has been reached. endstream endobj 266 0 obj <>stream 2. Imaging flow cytometry makes it possible. Alternative cleaning agents and procedures should be investigated. Initially turn each nut to a or turn, in the sequence shown in the illustration. This guide provides installation and maintenance procedures for Pellicon 3 cassettes. Compare the measured air flow rate to the specified flow value on the Certificate of Quality included with the cassette. 0000434465 00000 n Check for dirt or corrosion on tie rods or bolts, Remove old tape, re- tape adequately with PTFE tape, Missing O-ring or ferrule on fittings of defective sanitary gasket, Replace missing component, gasket, or entire fitting, Replace clamp with smaller diameter clamp, Disassemble stack, remove stack and check for debris, See remedy under Tube/Fitting Leaks above, Bubbling at external surface of filter stack, Dirt, debris or loose holder, or chemical incompatibility. Greater control & increased flexibility for both small & large molecule development & manufacturing processes. 0000020691 00000 n *H- Evenness of torque is critical to system performance. (A@%-$l# D%iq Install the Pellicon cassette (s) (Pellicon 2 Mini with 0.1 m2 membrane area, Pellicon 3 with 0.11 m2 membrane area) in the appropriate Pellicon holder. US EN. Show Pricing & Availability In-process controls are used to assure stability of the process. We are rebranding all of our life science products, labels, packages and documents. Continue with Recommended Cookies, Home Millipore Millipore Pellicon 3 Cassettes with Ultracel Installation Guide. NOTE: Use sanitization agents and conditions that are suitable for the process requirements. Create the perfect solution - match and clear hexagones. Ensure system is vented so that air is removed. Torque unit again; retest. Please refer to the cassette Validation Guide for this information. Protect the tie-rods from receiving any blows that could damage their threads, which can lead to galling. XXPEL3MAP Manifold Support Plate. 0000434299 00000 n deep hex socket supplied with the Pellicon Cassette Holder. 80 psi (5.5 bar) TMP @ 40C (initial use), 80 psi (5.5 bar) TMP @ 40 C (initial use), 30 psi (2 bar) @ 25 C ) @ 25C for 24 hours. Technical Information. The vibrant M, Millipore, Pellicon, Ultracel and Biomax are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. Once the pump has slowly ramped up to the set point, partially close the retentate valve (V4) to achieve the retentate pressure listed in the table above. 0000015947 00000 n Installation Three Pellicon 3 cassettes with 0.11 m2 of Ultracel 30 kDa mem-brane were individually installed in a holder and tightened with a cali-brated torque wrench at 180 in-lbs. 0000016173 00000 n Check thread for nicks or dents; if found replace tie rod or nuts. Install the grooved clamp rods, TC clamps, inserts and hand wheels. This P3B050A00 Pellicon 3 ultrafiltration device features a pore size of 50 kDa NMWCO, a filtration area of 88 cm 2, a Biomax 50 membrane, and dimensions . 271 0 obj <>/Filter/FlateDecode/ID[<30D83A402489844DA8D26F6F516EE507>]/Index[255 25]/Info 254 0 R/Length 81/Prev 463409/Root 256 0 R/Size 280/Type/XRef/W[1 2 1]>>stream We are the partner of choice for water purification systems and services. h6~nzsJS/>4b%:B#]>@ }FP-'PLI[Sc4vhLR;mYI F=I}pBvm6!y,Lge=Q2gm 1. AN1065EN00 Rev C.indd | Manualzz Recirculate the water for 10 minutes. On the first holder level (if there are more than one), remove the TC clamps and inserts holding the hydraulic cylinders to the clamp rods. Make sure feed line is fixed below fluid/air interface, Add baffle to break vortex or reduce mixing speed, Fix retentate line below fluid/in feed air interface container, Check feed tubing to pump connection for obstruction; remove obstruction or replace damaged/collapsed tubing. 0000013404 00000 n If proper holder maintenance is not performed, higher torque values will be required to achieve proper sealing. Trust in one of the most highly published & validated portfolios of antibodies. 0000020550 00000 n Replace the washers and nuts. ZabB~jdI4Km2U4pSjK)ee/2vPmTJA#$T[ z2Zt\mTS](,5pTeG4"Nzb8{XhAj2u{UZcaFVgY*[}+-n"|lWiLcq5LR]wm2dx5nG3Ajg22~ HU{1?-I/XBx|?.w`q L,[_/a?./7%]~\m]xMZ.^C_ZSA7utg: -5aS|Gs(I$fe.*1GTg1^{bro4FXRlAq'm$DK*rt)9$T+I1Kp=/h9SAx 2JG5X*` Turn the knurled locking collar counterclockwise to lock. endstream endobj 265 0 obj <>stream Close the tank outlet valve (V1) and drain valve (V2). To select a cleaning method, identify your application or suspected foulant from the Cleaning Agent Selection Chart. Slowly raise the air pressure to the recommended test value and wait at least 5 minutes to purge residual water in the permeate line. It is not intended to provide validation protocols or supporting data for validation purposes. Set the torque wrench to 40 to 45 Nm (350-400 in-lb). Pellicon 3 Cassette with Biomax Membrane filtration area 88 cm2 0000014313 00000 n Your email address will not be published. 170 mL in feed channel. 0000021130 00000 n Slide a Pellicon 3 Cassette onto the holder. We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development. Sanitization, depyrogenation and storage agents are chosen similarly. 6-W{IWq?q$}.w;u]pw8v0 2oxZtcX*q,NCqZ.\;i; QnBrE/M_[_=o Required fields are marked *. Are you sure you want to delete your template? This P3C010C01 Pellicon 3 ultrafiltration device features a pore size of 10 kDa NMWCO, a filtration area of 0.11 m 2, a PLCGC membrane, and dimensions . endstream endobj 264 0 obj <>stream Repeat the flushing procedure after cleaning to remove chemical residue from the cassette and system piping. 2. The pressure gauges need to be ordered separately by ordering catalog number XX4200075. Pellicon 3 Cassette with Ultracel Membrane filtration area 88 cm2 The system hydraulic pressure is maintained at 1950 psig 100 psig. 0000442148 00000 n Operating in the U.S. & Canada as MilliporeSigma, Advanced, high performance cassettes ideally suited to today's demanding filtration processes that require more rigorous operating pressures, temperatures and caustic cleaning regimes. 7. However, it may be possible to effect this type of separation between two proteins that have at least 10 X difference in molecular weight and if there is an ultrafiltration membrane available with a NMWL rating between the molecular weight of the two proteins. 30 psi at 25C for 24 hours. Training programs and seminars designed for you. Inspect the tie rods and nuts for signs of burrs or stripped threads. Screens, Exterior Housing, Fittings/connectors and Luer Caps: Optimum Tangential Flow Rate for Polarized Solutions. Clean nuts, washers and tie-rods before every use to ensure that they are free of particles. Filters may be stored in holders with the feed, retentate and filtrate isolation valves closed and enough compression on the cassettes to ensure that the storage fluid cannot escape or evaporate. Pellicon 3 Cassettes with Ultracel Membrane Performance Guide The Pellicon 3 Cassette with Ultracel Membrane is designed for the filtration of therapeutic proteins (such as monoclonal antibodies) and recombinant and non-recombinant proteins. endstream endobj startxref Preprocess EquilibrationA flushing step is utilized to ensure that the system and cassettes are properly prepared for processing. Polymeric Microspheres and Magnetic Beads, Novabiochem Peptide and DNA Synthesis Reagents, Analytics and Sample Preparation Services, Calibration, Verification and Suitability Testing, Process Solutions: Portfolio Announcements. Integral water &T](l%1m%Wwv&RK=\C/qpzqdJVB bm@;,=d,C^}`V,B Slide the Pellicon 3 cassette up against the manifold adapter plate. Loosen the nuts on the tie rods of the holder and remove the nuts, washers, tie rod spacers and end plate. This P3C030C05 Pellicon 3 ultrafiltration device features a pore size of 30 kDa NMWCO, a filtration area of 0.57 m 2, a PLCTK membrane, and dimensions . Please refer to the cassette Validation Guide for this information. Replace filter. "F$H:R!zFQd?r9\A&GrQhE]a4zBgE#H *B=0HIpp0MxJ$D1D, VKYdE"EI2EBGt4MzNr!YK ?%_&#(0J:EAiQ(()WT6U@P+!~mDe!hh/']B/?a0nhF!X8kc&5S6lIa2cKMA!E#dV(kel }}Cq9 0000031202 00000 n Sanitization pressures, flow rates and volumes are identical to those used during Cleaning. Increase torque if necessary. Slide the manifold adapter plate onto the holder against the holders manifold plate, with the solid light grey side labeled Manifold Side towards the manifold, and the wings resting on the tie rods. Pellicon3 Cassettes with UltracelMembrane Performance Guide. 0000016059 00000 n The consent submitted will only be used for data processing originating from this website. 0000021156 00000 n Converge, Intensify and Evolve. *Use milder conditions if effectiveness of agent is still observed. 11. Peracetic acid- containing Cold Sanitant*, Repeat Flushing Procedure. All Rights Reserved. Pellicon 3 Cassettes with Biomax Membrane - EMD Millipore This P3C005C00 Pellicon 3 ultrafiltration device features a pore size of 5 kDa NMWCO, a filtration area of 88 cm 2, a PLCCC membrane, and dimensions . Recommendations are based upon achieving optimal system performance. Slide the manifold adapter plate directly up against the stainless steel manifold. Advanced, high-performance cassettes ideal for todays higher titer therapeutic antibodies as well as the more demanding filtration processes require higher operating pressures, temperatures and caustic cleaning regimes.Pellicon 3 cassettes with Ultracel membranes are the optimum tangential flow filtration devices for the filtration of monoclonal antibodies and other therapeutic proteins.Pellicon 3 cassettes with Biomax membranes are the optimum tangential flow filtration devices for the filtration of solutions containing albumin, hormones, vaccines and growth factors. %PDF-1.7 % Use a few drops of suitable lubricant on the tie-rods and between the nuts and the washers if required. What Generation is Your Sterility Testing Pump? The Pellicon XL 50 allows process development and scaling studies. Repeat the procedure for any other holder levels. Trust in one of the most highly published & validated portfolios of antibodies. The Pellicon 3 Cassette with Ultracel Membrane is designed for the filtration of therapeutic proteins (such as monoclonal antibodies) and recombinant and non-recombinant proteins. 0000034846 00000 n Slide the manifold adapter plate or a stainless steel support plate onto the holder against the holders manifold plate. . Pellicon filters consistently deliver purity assurance at every stage and scale throughout the lifecycle of your drug products. Post Process CleaningCleaning and flushing steps are performed after product recovery and are intended to clean and sanitize the system and restore clean water permeability and process flux to within range. Recommended Sanitization Conditions and Agents. Manifold adapter plate for Pellicon 3 cassette manual process-scale holder and benchtop holder installation. Hand tighten the nuts in a diagonal pattern. Filters should not be frozen. You have already flagged this document.Thank you, for helping us keep this platform clean.The editors will have a look at it as soon as possible. Slide the manifold adapter plate onto the holder against the holders manifold plate, with the solid light grey side labeled Manifold Side towards the manifold, and the wings resting on the tie rods. New membranes should be cleaned, flushed and integrity tested before measuring NWP. Pellicon 3 Cassettes - Pellicon 3 Cassettes - Merck Set the torque wrench at 180 . All Rights Reserved. The Pellicon 3 Cassette with Biomax Membrane is perfect for the filtration of monoclonal antibodies and solutions containing albumin, hormones, vaccines and growth factors. All references to Merck refer to Merck KGaA, Darmstadt, Germany. 0000010245 00000 n Storage solution must be introduced into the system through the cassettes and the system piping to put the system in a bacteriostatic state in between process runs. Explore, interact. Slide the end plate onto the tie rods and press the end plate against the cassette. Pellicon 3 cassettes with Ultracel membrane for your ultrafiltration solutions. The Power Switch on the Hydraulic Control Unit HS-1 must be in the ON position, and the green Power Indicator must be illuminated. Using the torque wrench and 15/16 in. in-lbs or 40-62 Nm) as stated in the Pellicon 2 and 3 Filter Holders and Accessories User Guide (00109655PU), reflects the proper range of torque to provide the right compression force. All hydraulic flex hose connections must be installed from the Hydraulic Power Unit to the hydraulic cylinders. However, a chemical sanitization can be done; refer to the user guide for recommendations. It will maintain appropriate compression on the cassettes during processing or during storage of installed filter cassettes. 0000017145 00000 n The system hydraulic pressure is maintained at 1200 psig 100 psig. Pellicon 3 Cassette with Ultracel Membrane filtration area 88 cm2 endstream endobj 256 0 obj <>>>/Lang(en-US)/Metadata 122 0 R/Names 272 0 R/OCProperties<><><>]/ON[273 0 R]/Order[]/RBGroups[]>>/OCGs[273 0 R]>>/Outlines 210 0 R/Pages 248 0 R/Type/Catalog/ViewerPreferences<>>> endobj 257 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/Properties<>>>/Rotate 0/Tabs/W/Thumb 92 0 R/TrimBox[0.0 0.0 396.0 612.0]/Type/Page>> endobj 258 0 obj <>stream g&;8a>6$ITg7zO>@7_//pnc,,. With a continuous motion, turn each nut turn, alternating between the nuts, until the wrench clicks, which will indicate it has reached the set force. Learn More >> Pellicon 3 Cassettes Advanced, high performance cassettes ideally suited to today's demanding filtration processes that require . Millipore. Biopharma Application Guide Find the products and services for your process. The cleaning step applies to installations where all parts of the system will be exposed for a period of time to the process fluids. 0 ',Av]g_M&Ug3pZe3Op%]!i@_#(%F7~=0|:K )RBw_/G}nP%igyuWtXU#7{ 80 psi TMP at 4-40C; 40 psi TMP at 4-50C. Pioneering excellence with Steritest Symbio Pumps. Converge, Intensify and Evolve. 2023 Merck KGaA, Darmstadt, Germany and/or its affiliates. Pellicon3 Cassettes - Installation and User Guide. socket supplied with the Pellicon Cassette Holder. The filters may also be removed from the system and placed in sealed bags or containers. To relieve hydraulic system pressure at any time, set the System Mode Selector Switch to DUMP or open the System Pressure Manual Dump Valve, MV-1 on the left side of the Hydraulic Power Unit. HLA!Ds 0000021668 00000 n The acceptance criterion for cleaning efficacy as measured by NWP is membrane and application specific, and may vary between plants. The Pellicon XL 50 allows process development and scaling studies. Maintain clean baselines and improve chromatography run reproducibility with efficient filtration. hgb Lhghbh. ;B),ia6v'pG:(BNqqYLif;]`&Hlh#5;\*>:A{;w(>>|4ReSy1/;\aesq~CW)7{7Xv3JOELOj^32~ )U Turn on the feed pump and pump water into the feed port of the Pellicon holder. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page.. Conversion rate of approximately 30% is desired for 10, 30 and 50 kD devices and conversion rate of at least 10% and up to 30% is desired for 3 and 5 kD devices. Pellicon 2 Ultrafiltration Cassettes - EMD Millipore All hardware on the clamp rods must be in place. Both Pellicon 3 cassettes were challenged with bovine gamma globulin (BGG) solution formulated in 10 mM phosphate buffered saline, pH 7.2.
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