Yes, the SUTFF module requires a SUTFF module holder.  The SUTFF module must be placed in the SUTFF module holder and compressed to activate the seals.  The SUTFF module will leak if it is used without a module holder.  Refer to FAQ: What is the part number of the SUTFF module holder?

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No.  The membrane MWCO cannot be verified by the cassette integrity test.  The cassette integrity test cannot differentiate between a 10kD and 100kD membrane.  The membrane MWCO is verified by the solute passage test.  The membrane integrity test confirms if the cassette has been installed properly into the cassette holder, the torque has been applied sufficiently to activate the external seals, and there are no gross leaks on the membrane. 

SUTFF: 

Cadence® Single-Use Tangential Flow Filtration (TFF) Modules

Suspended-Screen Ultrafiltration Cassettes with Omega™ Membrane: Centramate™ and Centrasette™ II Cassettes

T-Series TFF Cassettes with Delta Membrane

T-Series TFF Cassettes with Omega™ Membrane

The SUTFF modules require a SUTFF module holder which is different from the Centramate or Centrasette cassette holder.  The Centramate and Centrastte cassette holders have built-in ports for feed, retentate, and permeate.  In SUTFF, these ports are located on one of the SUTFF module endplates, and there are no ports on the module holder.     

Proposed Pall website location (by product assignment):

Cadence® Single-Use Tangential Flow Filtration (TFF) Modules

The Cadence^® Single-Use Tangential Flow Filtration (TFF) Modules is intended for single-use only. There is no claim for re-using SUTFF module.

No. There is no sterility claim on our Cadence^® Single-Use Tangential Flow Filtration (TFF) Modules. The SUTFF modules are gamma-irradiated to reduce the bioburden and to be able to use water as the storage solution. The SUTFF module needs to be sanitized during the pre-use conditioning step.

No. The pre-assembled Cadence® Single-Use Tangential Flow Filtration (TFF) Modules are only available for 10kDa, 30 kDa, and 100 kDa Omega membranes.  The 300 kDa membrane is not a standard offering. If other molecular weight cut-offs are required, the end-user can evaluate the customized SUTFF module.  In the customized SUTFF assembly, standard Pall cassettes MWCO’s are offered and the module endplates and/or the flow distribution plates come separately. The end-user can assemble the SUTFF module on site.

The Cadence^® Single-Use Tangential Flow Filtration (TFF) Modules (P/N: CSUMxxxTxxx) have the fixed membrane area.  The customized SUTFF modules may have more than one cassette installed.  The total membrane area can be calculated by multiplying the membrane area of each cassette by the total number of cassettes installed. 

Forward Flow integrity specification for the Cadence® Single-Use Tangential Flow Filtration (TFF) Modules Modules with T-series Omega™ membrane is ≤ 1600 sccm/m² (150 sccm/ft²) at 2.0 barg (30 psig) test pressure. The unit sccm means standard cubic centimeters per minute. 

To calculate the maximum allowable air flow rate, multiply the total membrane area in the cassette holder by the Forward Flow integrity specification. 

For example, four Omega OS030T06 cassettes are installed in the customized SUTFF module holder.  The total membrane area is 2.0 m².  The maximum allowable air flow rate is 3200 sccm or 3200 mL/min.

Airflow rate=(Membrane area)×(Number of cassettes)×(Integrity specification)

Airflow rate=(0.5m^{^2} )×(4)×(1600 sccm/m^{^2} )=3200 sccm

Please refer to Pall Publication:

USTR 2896 Instructions For Use - “Cadence™ Single-Use Tangential Flow Filtration (TFF) Modules with Omega™ Membrane”