Pall Cadence ILC User Manual

User Guide
Cadence
Inline Concentrator
with Delta and Omega
Membranes
Care and Use Procedures
2
Contents
1. Important Information ...............................................................................................................................3
1.1 Safety Notice ........................................................................................................................................3
1.2 Application of the Care and Use Procedures .......................................................................................4
1.3 Using the Cadence Inline Concentrator (ILC) Module Safely ................................................................4
1.4 Locating Safety Information ..................................................................................................................5
1.5 Environmental Compliance ...................................................................................................................5
1.6 Where to Get Help ...............................................................................................................................5
2. Learning about the Cadence Inline Concentrator Module ....................................................................6
2.1 Cadence ILC Module ...........................................................................................................................6
2.2 Cadence ILC Module Information .........................................................................................................6
2.3 Cadence ILC Module Port Locations....................................................................................................6
3. Application of Single-Pass Tangential Flow Filtration.............................................................................7
3.1 Process Variables .................................................................................................................................7
3.2 Proper Use...........................................................................................................................................7
4. An Overview of Cadence ILC Processing ...............................................................................................7
4.1 The Four Parts of a Single-Pass TFF Process ......................................................................................7
5. Using the Cadence ILC Module ...............................................................................................................9
5.1 Preparation: Equipment and Materials..................................................................................................9
5.2 Part 1 — Pre-Use Conditioning ..........................................................................................................10
Procedure A — Connect the Cadence ILC Module to the Tubing ......................................................10
Procedure B — Flush the Cadence ILC Module with 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 ..........................................................................................................................15
Procedure I — Process Product ........................................................................................................15
Procedure J — Recover Product from the Cadence ILC Module........................................................15
5.4 Part 3 — Post-Use Conditioning ........................................................................................................16
Procedure K — Clean the Cadence ILC Module ................................................................................16
Procedure L — Flush the Cadence ILC Module with Purified Water ...................................................17
Procedure M — Determine Cadence ILC Module Normalized Water Permeability (NWP) ...................17
Procedure N — Test Integrity of the Cadence ILC Module .................................................................17
Procedure O — Add Storage Solution to the Cadence ILC Module ...................................................17
5.5 Part 4 — Post-Use Disposal ..............................................................................................................18
6. Appendices ..............................................................................................................................................18
6.1 Recommended Storage of New Cadence ILC Modules .....................................................................18
6.2 Delta and Omega Membranes Chemical Compatibility .......................................................................18
6.3 Alternative Chemical Agents ..............................................................................................................18
3www.pall.com/biotech
1. Important Information
1.1 Safety Notice
WARNING! Do not pressurize module over 4.1 barg (60 psig).
Important Notice
Refer to safety instructions before use. Safety instructions in this language are available from Pall.
Viktigt att notera
Läs säkerhetsinstruktionerna före användandet. Säkerhetsinstruktioner på svenska finns att få frän Pall.
Viktig melding
Les Sikkerhetsinstruksjonen før bruk. Sikkerhetsintruksjon på norsk vil være
tilgjengelig fra Pall.
Belangrijke informatie:
Voor gebruik veiligheidsinstructies goed doornemen. Veiligheids instructies in het Nederlands zijn bij Pall verkrijgbaar.
Avvertenza importante
Prima dell’uso leggere le istruzioni per la sicurezza. Le istruzioni per la sicurezza in Italiano possono essere richieste a Pall.
Important
Se référer aux instructions concernant la sécurité d’utilisation avant usage. Les instructions concernant la sécurité d’utilisation sont disponibles en français chez Pall.
Vigtigt
Læs sikkerhedsinstruktioner før ibrugtagning. Sikkerhedsinstruktioner på dansk kan fås fra Pall.
Tärkeä tiedote
Lue turvallisuusohjeet ennen käyttöä. Pall toimittaa tarvittaessa suomenkieliset turvallisuusohjeet.
Wichtige Anmerkung
Vor Gebrauch bitte die
Sicherheitsrichtlinien lesen. Die Sicherheitsrichtlinien in dieser Sprache erhalten Sie von 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.
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1.2 Application of the Care and Use Procedures
This guide describes the care and use of Cadence Inline Concentrator (ILC) modules with Delta and Omega 10 kDa and 30 kDa membranes. Do not apply these procedures to Pall’s conventional tangential flow filtration (TFF) cassettes or Cadence single-pass TFF (SPTFF) standard modules.
The care and use procedures described in this document apply to the products listed in Table 1:
Table 1
Cadence ILC module part numbers
Cadence ILC Module Part Number
Delta Membrane Omega Membrane MWCO* (kDa) Cassette Format
Membrane Area (m2)
ILD010T010407 ILOS010T010407 10 T01 0.065
ILD010T020407 ILOS010T020407 T02 0.13
ILD010T120407 ILOS010T120407 T12 0.7
ILD010T060407 ILOS010T060407 T06 3.5
ILD030T010407 ILOS030T010407 30 T01 0.065
ILD030T020407 ILOS030T020407 T02 0.13
ILD030T120407 ILOS030T120407 T12 0.7
ILD030T060407 ILOS030T060407 T06 3.5
* Molecular weight cut-off
1.3 Using the Cadence Inline Concentrator Module Safely
Read all safety warnings and operating instructions before using the Cadence ILC module. Keep this care and use 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 Data Sheets (available from the chemical suppliers) to learn how to use the recommended solutions safely.
• Do not exceed the operating limits of the Cadence ILC module or process components.
• Provide sufficient space around the Cadence ILC module to work ergonomically and safely when assembling and using the module.
• Disconnecting or dismantling Cadence ILC module components without first isolating and depressurizing the system or setup can lead to injury from the uncontrolled release of high pressure air and solutions. Depressurize the Cadence ILC module before dismantling components.
• Some system components may be heavy. Take proper precautions when moving or lifting equipment to prevent personal injury. Hoists or other lifting equipment may be needed to assemble some Cadence product equipment.
• Wipe up spills promptly to prevent injury from contact or slipping.
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1.4 Locating Safety Information
This care and use guide presents safety information as follows:
HELPFUL INFORMATION!
Communicates important and helpful information about the current topic.
CAUTION!
Identifies safety risks that could cause personal injury, or situations that may cause product damage.
WARNING!
Identifies safety risks that can cause serious personal injury, or situations that may cause irreversible damage to equipment.
1.5 Environmental Compliance
Users should dispose of storage and by-product solutions according to local, state, and federal regulations.
1.6 Where to Get Help
If you do not understand the information in this guide, or need additional 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 and provide replacement parts.
Pall operates a technical service to assist in the application of our products. This service is readily available to you and welcome your questions so that we can help. In addition, an extensive network of technical representatives is available throughout the world. For additional questions or technical assistance, you may contact BTASC@pall.com.
Web Site (http://www.pall.com/biotech) — Provides contact information for Pall Biotech offices throughout the world.
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2. Learning about the Cadence Inline Concentrator Module
2.1 Cadence ILC Module
The Cadence Inline Concentrator (ILC) is a self-contained, single-pass TFF module that simplifies TFF for volume reduction and continuous concentration applications. This plug-and­play module, comprised of membrane cassettes, gaskets and manifold plates enclosed between two end plates, eliminates the need for a holder and requires only a pressure source for operation.
Figure 1
Cadence Inline Concentrator T06 (3.5 m2) , T12 (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. Ports on the Cadence T01 and T02 modules use female Luer lock connectors. The ports on the Cadence T12 modules use female MPC quick disconnect connectors. A label located next to each port identifies the port’s function. The ports on the Cadence T06 modules use female MPX quick disconnect connectors.
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