|Scaling Up with Tangenital Flow Filtration|
Campbell, Melissa; Coons, Elizabeth
GEN; v. 21, no. 16; Sept. 15, 2001, p. 60 2001
|Validation of Tangential Flow Filtration (TFF) Systems|
Michaels, Stephen L.
Journal of Parenteral Science and Technology (Sept/Oct 1991). 1991
|What is the part number for the Gauge Kit that is used with the Pellicon XL?||Gauge Kit for Pellicon XL Device (0-60 psi):
Part number XXPXLGAGE, 1 per kit. Includes an inlet pressure gauge and t-fitting. This gauge is recommended when the Pellicon is used in the absence of a Labscale TFF system in order to ensure that the pressure on the tubing is known and not allowed to exceed it's recommended maximum.
|What is the sample volume range for the Pellicon II Mini system?||The Pellicon II Mini system is capable of volumes in the approximate range of 1- 50 L concentrating down to 100 mL. More or less volume can be processed depending on the individual needs of the operation, ie. process time, sensitivity of product, etc.|
|Pellicon® XL 50 Device Operating Instructions|
Pellicon® 2 Microfiltration CassettesA new standard in cassette style tangential flow filtration devices.
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Labscale TFF SystemEasy to use for sample preparation while also providing the necessary controls for process development and scale-up work.
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Small volume convenience yields high-end results with Millipore’s Pellicon® XL 50 Microfiltration Cassette. This high-performance tangential flow filter is the ideal choice for anyone contending with:
- Process Development Work (50 to 1000 mL range)
- Small Volume Processing
- Membrane Research
The long established Durapore® hydrophilic PVDF microfiltration membrane is well known for its exceptional combination of high flux, low protein binding, and high product recoveries.
Pellicon® XL 50 cassettes are 100% integrity tested in manufacturing to ensure consistent and reliable performance.
- Superior performance – its controlled channel height capability yields consistent, reliable and predictable results.
- Hyper Hydrophilic – Durapore’s superior hydrophilic membranes provide the lowest binding of proteins and other biologicals among all commercially available microporous membranes.
- Void-free Technology – guards against solute leakage.
- Self Contained – no holder required.
- Harvest, washing and clarification – of cell cultures, lysates and fermentation broths.
- Clinical trial support – quick preparation of materials
- Membrane selection – to study membrane efficacy
- Sample preparation – leaving larger equipment available
- Small volume manufacturing – same quality on a smaller scale
|Materials of Construction|
|Membranes:||Hydrophilic polyvinylidene fluoride (Durapore® membrane)|
|Screens, Exterior housing, Fittings/connectors and Luer Caps:||Polypropylene|
|Filtration Area||50 cm² (0.05 ft² )|
|Device Width||3.0 cm (1.2 in.)|
|Device Length||18.8 cm (7.4 in.)|
|Hold-up Volume (typical)||3.2 mL|
|Maximum Operating Pressure||5.6 bar (80 psig)|
|Optimum Tangential Flow Rate for Polarized Solutions||30 – 50 mL/min|
|Membrane pH Compatibility||1.5 – 9 (continuous)
1 – 11 (cleaning)
|Biocompatibility/Toxicity||All wetted parts have been tested and meet the requirements of the USP Class VI Biological Test for Plastics.|
|Extractables||Gravimetric extractables level < 7.5 mg/ device after RO water flush. USP oxidizables test negative after RO water flush.|
|Prefiltration Requirements||Prefiltration of sample using 100 μm nominal pore size filter is recommended.|