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Summary of Contents for Millipore Pellicon Single Pass TFF
- Page 1 ® Installation and User Guide Pellicon Single-Pass TFF Accessories ® The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada.
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Page 3: Table Of Contents
Pellicon Single Pass TFF Accessories Installation and User Guide ® Contents Introduction ................5 Catalog Numbers ............5 Pellicon Single-Pass TFF Installation .........6 ® Pellicon 2 Mini Cassette Installation ........6 ® Pellicon 2 Cassette Installation ........9 ® Pellicon 3 88 cm or 0.11 m Cassette Installation .... - Page 4 www.sigma-aldrich.com...
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Page 5: Introduction
Pellicon Single Pass TFF Accessories Installation and User Guide ® Introduction This guide provides installation and maintenance procedures for the Pellicon Cassette Single-Pass TFF Accessories. It is not ® intended to provide validation protocols or supporting data for validation purposes. Refer to the appropriate Pellicon Cassette ®... -
Page 6: Pellicon ® Single-Pass Tff Installation
www.sigma-aldrich.com Pellicon Single-Pass TFF ® Installation Pellicon 2 Mini Cassette Installation ® Required Equipment Items listed in this table are required for a three-section single- pass TFF installation with Pellicon 2 Mini Cassettes. Sections may ® be added or removed as needed for each specific application. Item Description Quantity Pellicon... - Page 7 Pellicon Single Pass TFF Accessories Installation and User Guide ® Installation Components Key Description Holder end plate Gasket Pellicon Single-Pass TFF Mini diverter plate ® Pellicon 2 Mini Cassette ® Tie rod spacer Port Descriptions Key Description User Supplied Connections Feed/retentate ports Cap or pressure gauge with cap Hose barb for tubing connection...
- Page 8 www.sigma-aldrich.com 1. Loosen the nuts on the tie rods of the holder and remove the nuts, washers, tie rod spacers, and end plate. 2. Slide the Pellicon 2 Mini Cassette gasket onto the holder so ® that the tie rods pass through the cutouts in the gasket. 3.
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Page 9: Pellicon ® 2 Cassette Installation
Pellicon Single Pass TFF Accessories Installation and User Guide ® Pellicon 2 Cassette Installation ® Required Equipment Items listed in this table are required for a three-section single- pass TFF installation with Pellicon 2 Cassettes. Sections may be ® added or removed as needed for each specific application. Item Description Quantity Pellicon... - Page 10 www.sigma-aldrich.com Installation Key Description Holder end plate Gasket Pellicon Single-Pass TFF Cassette diverter plate ® Pellicon 2 Cassette ® Pellicon Single-Pass TFF Cassette retentate collection plate ® 1. Loosen the nuts on the tie rods of the holder and remove the nuts, washers, tie rod spacers and end plate.
- Page 11 Pellicon Single Pass TFF Accessories Installation and User Guide ® 8. Slide a gasket onto the holder. 9. Install the next Pellicon 2 Cassette. ® 10. Complete the installation with the required number of diverter plates, alternating the location of the tabs on the diverter plates.
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Page 12: Pellicon ® 3 88 Cm
www.sigma-aldrich.com Pellicon 3 88 cm or 0.11 m Cassette ® Installation Required Equipment Items listed in this table are required for a three-section single- pass TFF installation with Pellicon 3 88 cm or 0.11 m Cassettes. ® Sections may be added or removed as needed for each specific application. - Page 13 Pellicon Single Pass TFF Accessories Installation and User Guide ® Installation Components Key Description Holder end plate Gasket Single-Pass TFF Mini diverter plate Pellicon ® Pellicon 3 88 cm or 0.11 m Cassette ® Tie rod spacer Port Descriptions Key Description User Supplied Connections Feed/retentate ports Cap or pressure gauge with cap...
- Page 14 www.sigma-aldrich.com 1. Loosen the nuts on the tie rods of the holder and remove the nuts, washers, tie rod spacers and end plate. 2. Slide a gasket onto the holder. 3. Slide the Pellicon Single-Pass TFF mini diverter plate onto ®...
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Page 15: Pellicon ® 3 0.57 M
Pellicon Single Pass TFF Accessories Installation and User Guide ® Pellicon 3 0.57 m or 1.14 m Cassette ® Installation Required Equipment Items listed in this table are required for a three-section single- pass TFF installation with Pellicon 3 0.57 m or 1.14 m Cassettes. - Page 16 www.sigma-aldrich.com Installation Key Description Holder end plate Pellicon Single-Pass TFF Cassette diverter plate ® Pellicon 3 0.57 m or 1.14 m Cassette ® Pellicon Single-Pass TFF retentate collection plate ® Pellicon 3 manifold adapter plate ® 1. Loosen the nuts on the tie rods of the holder and remove the nuts, washers, tie rod spacers and end plate.
- Page 17 Pellicon Single Pass TFF Accessories Installation and User Guide ® 7. Complete the installation with the required number of diverter plates, alternating the location of the ports on the diverter plates. 8. To finalize the serial flow path, install the Pellicon Single- ®...
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Page 18: Flushing And Cleaning
www.sigma-aldrich.com Flushing and Cleaning NOTE The following flushing and cleaning recommendations are based on three cassettes in series. These recommendations are guidelines. Actual flushing and cleaning volumes and operating conditions depend on the membrane type, cutoff, and screen used, as well as the applied flow rate and retentate pressure. -
Page 19: Cleaning
Pellicon Single Pass TFF Accessories Installation and User Guide ® Cleaning To select a cleaning method, identify the application or suspected foulant from the Cleaning Conditions section of the appropriate cassette user guide. Select the cleaning agent or agents compatible with the membrane type and application requirements. -
Page 20: Sanitization
www.sigma-aldrich.com Sanitization Sanitization should always be performed after the membrane has been thoroughly cleaned and flushed to reduce bioburden. Sanitization pressures, feed flow rates and volumes are identical to those used for cleaning. See the Cleaning procedure. Select a sanitization agent from the appropriate user guide. -
Page 21: Depyrogenation
Pellicon Single Pass TFF Accessories Installation and User Guide ® Depyrogenation Depyrogenation should only be performed after the system has been cleaned, sanitized, and flushed. Depyrogenation feed flow rate, pressure and volumes are identical to those used for cleaning. See Cleaning. Water for injection should be used during depyrogenation. -
Page 22: Integrity Testing
www.sigma-aldrich.com Integrity Testing The module integrity should be tested on a cleaned and thoroughly flushed system. The presence of residual cleaning agents can significantly alter integrity test results. Integrity testing should be performed on a water-wet membrane only. 1. Ensure that the system is thoroughly cleaned and that the membrane is thoroughly wetted. - Page 23 Pellicon Single Pass TFF Accessories Installation and User Guide ® 8. Compare the measured air flow rate to the specified flow value in the Certificate of Quality of the appropriate cassette. If the measured air flow rate is equal to or less than the maximum specified value, the cassette may be used for processing.
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Page 24: Measurement Of Normalized Water Permeability (Nwp)
www.sigma-aldrich.com Measurement of Normalized Water Permeability (NWP) The normalized water permeability (NWP) for Pellicon Cassette ® membranes should be established prior to the first use of each filter. New membranes should be cleaned, flushed, and integrity tested before measuring NWP. The NWP measured at this point is used as a benchmark against subsequent NWP measurements to determine cleaning efficacy. - Page 25 Pellicon Single Pass TFF Accessories Installation and User Guide ® Open the permeate line of the cassette being measured and close the permeate lines of the cassettes not being measured. Use the retentate valve to adjust the outlet pressure of the cassette being measured.
- Page 26 www.sigma-aldrich.com There may be an initial NWP decline after initial use and exposure to cleaning solutions. Stable NWP from run to run is achievable thereafter until the membrane starts to reach the end of life, at which point a steady change in NWP will usually be observed and process performance measurements such as process time, permeate flux or product yield are affected.
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Page 27: Storage
Pellicon Single Pass TFF Accessories Installation and User Guide ® Storage After the system has been thoroughly cleaned, flushed, and tested, it can be stored until needed for processing. Storage pressures, feed flow rates, and volumes are identical to those used for cleaning. Refer to the appropriate user guide for storage solutions. -
Page 28: Standard Product Warranty
www.sigma-aldrich.com Standard Product Warranty The applicable warranty for the products listed in this publication may be found at www.emdmillipore.com/terms (within the “Terms and Conditions of Sale” applicable to your purchase transaction). For worldwide contact information and technical assistance please visit: www.sigma-aldrich.com For additional information and documentation please contact:... - Page 29 The vibrant M, Millipore, and Pellicon are registered trademarks of Merck KGaA, Darmstardt, Germany. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. 00120342PU Rev 2 9/2018 © 2014-2018 Merck KGaA, Darmstadt, Germany, and/or its affiliates. All Rights...
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