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User Guide

Cadence

™

Inline Concentrator

with Delta and Omega

™

Membranes

Care and Use Procedures

USD 2841c

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Summary of Contents for Cadence ILC

Page 1: ...User Guide Cadence Inline Concentrator with Delta and Omega Membranes Care and Use Procedures USD 2841c ...

Page 2: ... Purified Water 10 Procedure C Sanitize the Cadence ILC Module 11 Procedure D Flush the Cadence ILC Module with Purified Water 11 Procedure E Determine Cadence ILC Module Normalized Water Permeability NWP 12 Procedure F Determine the Hold Up Volume of the Cadence Setup and Module 13 Procedure G Test the Integrity of the Cadence ILC Module 14 Procedure H Flush with Buffer 15 5 3 Part 2 Processing 1...

Page 3: ...uzioni per la sicurezza in Italiano possono essere richieste a Pall Aviso importante Antes de utilzar consultar instruçöes de segurança Instruçöes de segurança em Português encontram se disponiveis na Pall Aviso importante Antes de usar consultar Instrucciones de Seguridad Instrucciones de Seguridad en este idioma están disponibles por Pall Important Se référer aux instructions concernant la sécur...

Page 4: ... guide in an accessible location and make it available to users of the Cadence ILC modules General safety precautions include Wear the appropriate personal protective equipment PPE and clothing including safety glasses and gloves when working with Cadence ILC modules systems and chemical solutions The solutions recommended for sanitization may be hazardous or corrosive Refer to the Material Safety...

Page 5: ...assistance in using Cadence ILC modules contact Pall Pall provides these additional resources to help make your experience with our products trouble free Materials Safety Data Sheets Offer safety information about the chemicals used to store Cadence ILC modules and are available online at www pall com procedures Support Services The Pall Biotech customer support team can answer technical questions...

Page 6: ...0 7 m2 and T01 0 065 m2 formats 2 2 Cadence ILC Module Information Inscription on each Cadence ILC module includes the following information Company logo and name Product name Part number Serial number Port labels Product pressure rating Pall patent website address Membrane type Total membrane area 2 3 Cadence ILC Module Port Locations Cadence ILC modules have feed retentate and two permeate ports...

Page 7: ...variables Product characteristics i e concentration viscosity temperature and shear sensitivity Concentration factor ranges Feed pressure or feed flow rate Process control with the Cadence ILC module can be easily achieved by setting either the feed pressure or feed flow rate to reach processing targets Please contact Pall for single use Allegro systems or assemblies to operate the Cadence ILC mod...

Page 8: ...le is a disposable device It could potentially be used several times However specific end user studies should be conducted to identify the limited re use range and validate specific re use requirements per application Figure 3 Main parts of a Cadence ILC process and the procedures required to complete each part Pre Use Conditioning A Connect Cadence Module B Remove Air Flush with Water Processing ...

Page 9: ...ype connectors and in internal diameter ID that needs to withstand 4 1 barg 60 psig For a Cadence system with Cadence T12 modules MPC quick disconnect fittings in ID that needs to withstand 4 1 barg 60 psig For a Cadence system with Cadence T06 modules MPX quick disconnect fittings in ID that needs to withstand 4 1 barg 60 psig Personal protective equipment as required by OSHA U S Occupational Saf...

Page 10: ... modules are operated without a holder The module must always rest on its bottom feet and never on its side to avoid damage to the ports CAUTION Do not exceed a feed pressure of 4 1 barg 60 psig at 20 40 C during any pre use processing or post use procedures Exceeding 4 1 barg 60 psig of feed pressure can permanently damage the Cadence ILC module or lead to product leakage Do not exceed a feed pre...

Page 11: ... feed line to a supply of sanitization solution see Section 5 1 at ambient temperature 2 Direct permeate and retentate lines to drain 3 Fully open the feed retentate and permeate 2 lines and close the permeate 1 line 4 Start the feed pump and slowly increase the pump speed until the feed pressure reaches 1 4 2 8 barg 20 40 psig 5 Open the permeate 1 line for 1 minute and close for the remainder of...

Page 12: ... valve a few times to expel any trapped air 4 Adjust the feed pump and increase the pump speed to deliver a feed pressure value of 1 barg 15 psig and measure record the corresponding permeate flow rate 5 Record the temperature of the permeate stream 6 Stop the feed pump Normalize the permeate flux to 20 C following these steps 1 Using the permeate flow rate measurements from step 4 above calculate...

Page 13: ...ION This step should be performed prior to using the system for processing for the first time This step is not required for future process runs utilizing the same system plumbing and same module size Follow these steps to determine the hold up volume 1 Open the feed and retentate lines and close both permeate lines 2 Direct the retentate line to a collection vessel 3 Disconnect the feed line from ...

Page 14: ...om the permeate port is less than the values stated in Table 3 the Cadence ILC module is integral If the flow from the permeate port is greater than these values the module has failed the integrity test If a module fails the integrity test please contact Pall for further assistance 6 Stop the compressed air source or pump and gradually depressurize the module by slowly opening the retentate line v...

Page 15: ...PTFF following the procedures in Part 2 Processing 5 3 Part 2 Processing u Procedure I Process Product Before initiating the processing step review the recommended operating parameters below Follow these steps to process feed material with the Cadence ILC module 1 Connect the feed line to the feed solution 2 Place the retentate and permeate lines into separate collection vessels 3 Fully open the f...

Page 16: ...e would be utilized for multiple batches or for a specific campaign This section is optional and is not applicable when considering single use processes Document and validate the cleaning process for biopharmaceutical applications u Procedure K Clean the Cadence ILC Module If a sufficient amount of product has been removed from the module with buffer flushing during product recovery proceed direct...

Page 17: ...e the membrane NWP following the steps in Procedure E Determine Cadence ILC module Normalized Water Permeability NWP As explained in Procedure E a membrane NWP measurement before use and after use and cleaning will provide a comparison to determine the effectiveness of the cleaning process Between uses modules are typically stored in a sodium hydroxide solution e g 0 1 N NaOH During this time rema...

Page 18: ...nctional characteristics of the membrane such as retention characteristics Pall offers validation services to test compatibility of membranes and modules with different solvents Contact your local representative for information on Validation Services 6 3 Alternative Chemical Agents The User Guides for T Series cassettes USTR2662 Delta and USTR2433 Omega offer more information on appropriate altern...

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