Related Manuals for Pall T Series
Summary of Contents for Pall T Series
- Page 1 User Guide USTR 2433b T-Series TFF Cassettes with Omega™ Membrane Care and Use Procedures For use with Centramate™ and Centrasette™ TFF Systems...
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Page 2: Table Of Contents
2.2.1 Preparation for Loading Cassettes ..............11 2.2.2 Unpacking the Cassettes ..................11 2.2.3 Installing Cassettes and Gaskets ..............13 2.3 How to Torque Pall T and MT Cassette Holders ............14 3. Operating Specifications ....................17 3.1 Recommended Cross Flow Rates for T-Series Cassettes with Omega Membrane ..17 3.2 Operating Pressures, Temperatures and pH ..............18... - Page 3 5.6.1 Recommended Storage gents for Omega Membranes ........45 5.6.2 dding Storage gent to System ..............45 5.6.3 Recirculate Storage Solution ................46 5.6.4 Cassette Storage ....................46 6. ppendix ..........................47 6.1 Omega Membrane Chemical Compatibility Chart ............47 6.2 lternative Cleaning gents ..................48 7. Glossary ...........................49 www.pall.com/biopharm...
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Page 4: Safety Notice
Antes de utilzar, consultar instruçöes de segurança. Instruçöes de segurança em Português, encontram-se disponiveis na Pall. This guide is designed for T-Series cassettes with Omega membrane only. The specifications detailed in this document do not apply to other Pall tangential flow filtration membranes and cassettes. -
Page 5: Learn Bout Safety
Inspect the holder and seals regularly to detect damaged components. Pre-use Recommended Storage Conditions Pall cassettes can be expected to perform within specifications if stored and handled in a manner consistent with the parameters below: • The cassette is stored unopened in the original packaging at 4 to 25 ºC and in a dry environment. -
Page 6: Safety Conventions In This Manual
Caution: This guide is designed only for T-Series cassettes with Omega membrane. Its contents and specifications do not apply to other Pall tangential flow filtration membrane cassettes. Tangential Flow Filtration Process The process conditions for using membrane cassettes in a Tangential Flow Filtration system depend on the specific application. -
Page 7: The Tff Process
Pall T-Series screen channel cassettes with Omega membrane. Some processes may require adaptations to suit the specific requirements of a given system configuration or application, but essential protocols should not be omitted. To perform these procedures, it is recommended that the TFF assembly include 3 pressure gauges/transducers and 2 valves for proper execution of the protocols presented, see Figure 2. -
Page 8: System Hardware Configurations
System Hardware Configurations System hardware configurations vary, but should all have key components (Figure 2). ll TFF systems should have: Feed/Retentate Flow Path • Sample/feed tank • Feed pump • Feed and retentate pressure gauges or transducers • djustable retentate valve •... -
Page 9: System Design
The permeate side of most TFF cassette holders have two ports. While these ports in Pall TFF holders are internally connected through the cassettes, closing off one of the ports can create an internal pressure drop in the cassette at high permeate flow rates, >... -
Page 10: Making A Flushing Gasket
2.1.2 Making a Flushing Gasket Flushing gaskets (also called SIP/CIP plates) are not supplied with holders, but flushing gaskets for Centramate and Centrasette holders may be purchased (see Table 20 in ppendix). In the generic drawing (Figure 3), the dotted line illustrates where to cut the gasket. The cut line should bisect the channel holes while providing about 2 cm (0.75 in.) of space around the outside of the gasket. -
Page 11: Installing T-Series Membrane Cassettes With Omega Membrane Into Utotorque ( T) And Manual Torque (Mt) Holders
Open the cassette package carefully! To avoid accidental exposure to the storage reagent, open the cassette package over a container or sink. Please see photos below for proper handling: 1. Remove cassette package from shipping container. Figure 5 Cassette Package in Shipping Container www.pall.com/biopharm... - Page 12 2. Use scissors to cut below the seal of the outer bag. Do not to cut the inner bag seal. Figure 6 Opening Outer Bag 3. Remove cassette (still in the inner bag) from the outer bag. Figure 7 Cassette Package in Inner Bag 4.
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Page 13: Installing Cassettes And Gaskets
For auto-torque holders, ensure that the piston is fully retracted into the hydraulic cylinder before hand tightening the nuts. If it is not, push the piston in by hand (with no hydraulic pressure applied to the system). www.pall.com/biopharm... -
Page 14: How To Torque Pall T And Mt Cassette Holders
Gasket Hardware Manifold How to Torque Pall T and MT Cassette Holders 1. Install the membrane cassette and gaskets in the holder according to Section 2.2. 2. Choose the value at the low end of the hydraulic pressure range for T assemblies (Table 1) or the torque range for MT holders (Table 2) —... - Page 15 For example, tighten the first nut ⁄ turn, and then tighten the next nut in the sequence ⁄ turn. Figure 13 Pall Manual-Torque Cassette Holders and Torquing Sequence Centramate LV Centrasette LV Centrasette P Centramate Centrasette 5 Centrasette 10...
- Page 16 The torque required to apply the correct clamping force on cassettes depends on the size and number of tie rods and the surface area over which the force is applied. On Pall T hydraulic closure systems, it also depends on the diameter of the pistons. Values listed in Table 1 and Table 2 are recommended for cassettes from Pall Life Sciences.
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Page 17: Operating Specifications
Operating Specifications Recommended Cross Flow Rates for T-Series Cassettes with Omega Membrane Table 3 lists recommended cross flow flux (CFF) rates for operating Pall TFF cassettes with Omega membrane. Other parameters such as TMP and temperature can be evaluated at these CFF values. -
Page 18: Operating Pressures, Temperatures And Ph
Operating Pressures, Temperatures and pH Operating limit specifications for pressure, temperature, and pH are listed in Table 4. Table 4 Cassette Operating Limits of Pressure, Temperature, and pH for T-Series Cassettes with Omega Membrane ( ll Formats) Maximum Recommended Operating Pressure Maximum TMP Temperature Range pH Range... -
Page 19: Determining Permeate Hold-Up Volume
6. Record the volume remaining in the cylinder (D). The difference between the total volume added ( *) and the volume remaining in the cylinder (D) is the total system hold-up volume (feed/retentate and permeate). Subtract the feed/retentate hold-up volume (C) to get the permeate hold-up volume (F), Table 7. www.pall.com/biopharm... -
Page 20: Determining The Non-Recoverable Volume
Table 7 Total System Hold-up Volume Calculation Chart Total Volume dded ___________ mL ( *) Remaining Volume In Graduated Cylinder – ___________ mL Total System Hold-up Volume (feed/retentate/ permeate) ( * – D) = ___________ mL Feed/Retentate Hold-up Volume from Table 6 –... -
Page 21: Preconditioning T-Series Cassettes And Systems
This preconditioning process consists of six steps: Figure 14 Steps for Preconditioning T-Series Cassettes Install Cassettes Determining Hold-up Volume Buffer Determine Integrity WFI Flush Sanitize WFI Flush Condition Test Step Optimization or Processing Mode www.pall.com/biopharm... -
Page 22: Using A Cassette For The First Time
The combination of steps 1 to 3 are required to assure that the storage agents have been effectively and sufficiently removed. Step 1 WFI Flush, quickly removes the bulk of the storage agent, so only small quantities of water are required in this step. -
Page 23: Sanitizing And Depyrogenating The Cassette And Ssembly
7. Pass 10 L/m (1 L/ft ) to waste. 8. Stop the pump. Sanitizing and Depyrogenating the Cassette and ssembly The following agents and conditions are recommended for sanitizing the specific Pall Omega membrane types listed: Volume Required: 5 L/m (0.5 L/ft Sanitizing and Depyrogenating Solutions: 0.1 to 0.5 N NaOH at 40 to 45 °C... -
Page 24: Dd And Recirculate Sanitizing Solution
4.3.1 dd and Recirculate Sanitizing Solution Figure 16 Set-up For Circulating Sanitizing Fluid Retentate Permeate Feed Tank Pump Feed Procedure 1. Drain the system and feed tank. 2. Direct the retentate and permeate lines into the feed tank. 3. Fill the feed tank with sanitizing solution. 4. -
Page 25: Flush The Retentate And Permeate Line To Waste
5. djust the retentate valve to split flow 25% retentate, 75% permeate. 6. Readjust pump to give required retentate flow rate. 7. Pass 30 L/m (3.0 L/ft ) to waste. 8. Stop the pump. 4.4.2 Water Recirculation Volume Required: 8 L/m (0.85 L/ft ) minimum Temperature: 25 °C www.pall.com/biopharm... -
Page 26: Flush The Retentate And Permeate Line To Drain
Figure 18 System Recirculation Setup Retentate Permeate Feed Tank Pump Feed Procedure 1. Fill the feed tank with required volume of water. 2. Direct the retentate and permeate lines into the feed tank. 3. Open the retentate and permeate valve. 4. -
Page 27: Determine Normalized Water Permeability (Nwp20 °C) For Cassettes
Note: If the cleaning protocol for the process uses harsher conditions (such as higher concentration, higher temperature, or a different cleaning agent) than the sanitization procedure, then it is recommended that a full cleaning protocol and flushing be performed prior to performing the initial NWP 20 °C www.pall.com/biopharm... -
Page 28: Remove Ir From Cassette And System
4.5.1 Remove ir from Cassette and System Caution: It is important to completely remove air from the feed channels to wet out the membrane before determining NWP . Both permeate ports should be open 20 °C for determining NWP . Closing one port can cause a significant error in TMP 20 °C measurement due to internal pressure drops. - Page 29 Be sure to use calibrated equipment that is accurate within the measurement range. Use pressure gauges and transmitters with a maximum range of 0 to 2 barg (0 to 30 psig) for accurate, repeatable results. www.pall.com/biopharm...
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Page 30: Normalize The Water Permeability
4.5.3 Normalize the Water Permeability 1. Normalize the water permeability to a temperature of 20 °C using Equation 5: Normalized Water Permeability Calculation and the temperature correction factors (TCF ) in Table 11. 20 °C Equation 5 Normalized Water Permeability Calculation Permeate Flux Rate (LMH) X TCF 20 °C... -
Page 31: System And Membrane Cassette Integrity Test
The Membrane Cassette Integrity Test checks the membrane and internal seal assemblies within the cassette for defects. The System Integrity Test is usually performed first. This assures that any airflow measured during the Membrane Cassette Integrity Test is not the result of an external leak. www.pall.com/biopharm... -
Page 32: Drain The System (Feed/Retentate Flow Path)
Performing a System Integrity Test is recommended but not required. If the Membrane Cassette Integrity Test passes, the integrity of the membranes and system is confirmed. However, if the Membrane Cassette Integrity Test fails, then the System Integrity Test should be performed to confirm that no external leaks contribute to the measured airflow. -
Page 33: System Integrity Test (External Test)
4. The air flow rate displayed on the integrity test unit will initially increase as the system pressurizes, then drop before leveling off to a constant flow rate. This measured constant mass flow rate is the air forward flow (diffusion) rate (Figure 23). www.pall.com/biopharm... -
Page 34: Troubleshooting System Integrity Failure
4. Repeat the Membrane Cassette Integrity Test (Section 4.6.3). If the cassette still fails an integrity test, contact your local Pall representative for assistance. If multiple cassettes are installed and the air diffusion rate continues to exceed specification limits, disassemble the stack of cassettes and test the integrity of each cassette individually to determine if integrity failure is specific to a cassette. -
Page 35: Buffer Conditioning
3. Start the pump and increase pump speed until liquid begins to flow through both the retentate and permeate lines. If necessary, adjust the retentate valve to force flow through permeate. 4. Run for 5 to 10 seconds, then stop. www.pall.com/biopharm... -
Page 36: Remove Trapped Ir From The Retentate Line
4.7.2 Remove Trapped ir from the Retentate Line Direct the retentate and permeate lines to feed tank. Figure 25 Setup for Buffer Conditioning — Recirculation Retentate Permeate Feed Tank Pump Feed Procedure 1. Set up the system for recirculation. 2. Open the retentate and permeate valves. 3. -
Page 37: Post-Use Treatment Of Cassettes And System
5.1.1 Flush the Feed/Retentate Line to Waste Volume Required: 10 L/m (1.0 L/ft Direct the retentate and permeate lines to waste. Figure 27 System Setup for Flushing to Waste Retentate Permeate Feed Tank Waste Waste Pump Feed www.pall.com/biopharm... -
Page 38: Flush The Permeate Line To Waste
5 L/m (0.5 L/ft ) minimum Recommended cleaning agents for Pall membranes (see Section 6.2): Membrane Types: Omega Cleaning Solutions: 0.1 to 0.5 N NaOH at 25 to 45 °C 0.1 to 0.5 N NaOH + 200 to 400 ppm NaOCl at 25 to 45 °C Warning: Many solutions that are recommended for cleaning may be corrosive. -
Page 39: Recirculate Cleaning Solution
To establish required flushing volumes for a specific application, test the pH and/or conductivity of water from the retentate to determine when acceptable conditions have been reached. If the product will be in the permeate, test the pH and conductivity of the permeate. www.pall.com/biopharm... -
Page 40: Flush The Retentate Line To Waste
5.3.1 Flush the Retentate Line to Waste Figure 29 System Setup for Flushing Cleaning Solution to Waste Retentate Permeate Feed Tank Waste Waste Pump Feed 1. Drain, wash, and refill the feed tank with water (or attach the feed line to the water supply). -
Page 41: Determine Membrane Recovery For The Cassettes
Water quality should be Water for Injection (WFI) or, at minimum, 0.2 µm filtered DI water. ll water permeability rates are normalized to a temperature of 20 °C by using a temperature correction factor (TCF ) obtained from Table 11. 20 °C www.pall.com/biopharm... -
Page 42: Remove Ir From Cassette And System
5.4.1 Remove ir from Cassette and System Caution: It is important to completely remove air from the feed channels and wet out the membrane before determining NWP 20 °C Direct the retentate and permeate lines back to the feed tank to minimize the volume of water needed. - Page 43 0.3 barg (5 psig) Use pressure gauges and transmitters with a maximum range of 0 to 2 barg (0 to 30 psig) for accurate, repeatable results. 11. Calculate the water permeability at the recorded TMP from Equation 7: Water Permeability Calculation. www.pall.com/biopharm...
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Page 44: Normalize The Water Permeability
Equation 7 Water Permeability Calculation Permeate Flux Rate (LMH) Water Permability = 5.4.3 Normalize the Water Permeability Normalize the water permeability to a temperature of 20 °C using Equation 9: Calculation for Membrane Recovery and the temperature correction factor (TCF 20 °C in Table 11. -
Page 45: Storage Of Membrane Cassettes
2. Open the retentate and permeate valves. 3. Start the pump and increase speed until the flow comes through both the retentate and permeate lines. llow a volume equivalent to about 2 hold-up volumes to pass out of the retentate to waste. www.pall.com/biopharm... -
Page 46: Recirculate Storage Solution
4. llow a volume equivalent to about 2 hold-up volumes to flow from the permeate to waste. If necessary, partially close the retentate valve to increase permeate flow rate. 5.6.3 Recirculate Storage Solution Figure 33 System Setup for Recirculating Storage Solution Retentate Permeate Feed... -
Page 47: Ppendix
Data for cassette membrane and components at 20 °C, 24-hour exposure, unless otherwise noted. There may be changes in porosity and/or selectivity of membrane. Pall offers validation services to test compatibility of membranes and cassettes with different solvents. Contact your local Pall representative for information on Validation Services. -
Page 48: Lternative Cleaning Gents
lternative Cleaning gents Table 16 lternative Cleaning gents Agent Mode of Cleaning Foulant Alkalies High pH hydrolysis Biomolecules, fats, proteins, starches Solubilization Acids Solubilization Inorganic salts Oxidizers Oxidation degradation Biomolecules, proteins, polysaccharides Surfactants Wetting, emulsification, dispersion, Biomolecules, fats, oils, proteins, solubilization insoluble particles Solvents... -
Page 49: Glossary
90% retained by that membrane after a 2X concentration. Retention of molecules of the same molecular weight, but which have elongated shapes, can be significantly lower. Concentration polarization, which occurs during ultrafiltration, can affect the retention characteristics of the membrane. www.pall.com/biopharm... - Page 50 Non-Recoverable Volume The volume remaining in the Feed/Retentate flow path after the flow channel has been pumped out/drained. Optimization of the product recovery step will insure high product recovery. Normalized Water Permeability (NWP) The water flux measured at 20 °C, divided by the average applied transmembrane pressure (TMP). Permeate Flux Rate (LMH) X TCF 20 °C...
- Page 51 The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly. © 2009, Pall Corporation. Pall, , Centramate, Centrasette, Centrastak, Omega and Palltronic are trademarks of Pall Corporation.
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