|Clarification and Recovery of Recombinant Proteins using a Cascade Tangential Flow Filtration (TFF) System|
|Pellicon® 2 Filters and Holders|
|Tetanus Toxoid Purification: A Case Study|
Vancetto, Mary Dalva Caparroz, Jose Marcos de Oliveira, Sally Muller Affonso Prado, Fernando Fratelli, and Hisako Gondo Higashi; Nature Biotechnology Volume 15
Nature Biotechnology Volume 15 1997
|Evaluation of Microporous Tangential-Flow Filtration in the Production of Diphtheria and Pertussis Vaccines|
Rao, Y. Udaya Bhaskara, M.S. Mahadevan, and Stephen L. Michaels; Pharmaceutical Technology
Pharmaceutical Technology 1992
|Validation of Tangential Flow Filtration (TFF) Systems|
Michaels, Stephen L.
Journal of Parenteral Science and Technology (Sept/Oct 1991). 1991
|Can the Pellicon II cassettes be used with older Pellicon holder?||Yes, the new Pellicon II cassettes may be used the old Pellicon I holder. They will fit for operation without any adaptation.|
|How many cassettes can fit into the Pellicon II Mini holder at one time?||The Pellicon II Mini holder can hold from one to three of the Mini cassettes at one time. As a general rule of thumb, for every 10 L of process volume, add a cassette to the system.|
|What are the materials of construction for the Pellicon cassettes?||The cassettes are made of the specified membrane material, polypropylene screens, and a polyurethane adhesive. When checking compatibility with a particular solution, it is necessary to check compatibility with all of these materials.|
|What are the recommended tangential flow rates for each of the screen channel products in the Pellicon cassettes?||For the A Screen modules, there is a recommended flow rate of 4-9 L/min/m2.
For the C screen modules, there is a recommended flow rate of 9.5- 14.6 L/min/m2.
For the V Channel modules, there is a recommended flow rate of 19.6- 33 L/min/m2.
|Are the TFF membranes autoclavable or steam sterilizable?||The membranes for Pellicon XL, Helicon UF, Helicon RO, spiral wound/prep/scale, Prostak UF and Pellicon 2 are not autoclavable or steam sterilizable. However, a chemical sanitization can be done; refer to the maintenance manual for these membranes.
Note: Prostak Open Channel with microporous Durapore membranes can be steam sterilized.
|What pH range is compatible with my Pellicon membrane?||The pH ranges are listed on the data sheets: The PES is 1-14 and the Regenerated Cellulose is 2-13|
|What is Normalized Water Permeability?||NWP is a measure of the ability of pure water to pass through the filter membrane. NWP is a property of the TFF system and is contributed to by the membrane as well as the feed and permeate flow paths in the filter.|
|How does NWP aid in effective cleaning procedure development?||Fouling and polarization leave residues on the membrane that can reduce filter permeability. Effective cleaning removes these residues, restoring the permeability of the membrane. Ideally, NWP after cleaning should equal NWP before use although there can be variation up to +/-15% due to membrane compaction under pressure and measurement error.
NWP validates the ability of cleaning to restore filtration rate of a system.
|What is the hold-up volume of a Pellicon 2 Mini cassette?||The approximate hold-up volume for a Pellicon 2 mini cassette (0.1m2) is 18 ml upstream and 10 ml downstream.|
|What is the hold-up volume for a Pellicon 2 Maxi cassette (2.5m2)?||The approximate hold up volume for the Pellicon 2 Maxi cassettes is 450 ml on the feed side and 250 ml on the permeate side.|
Pellicon® XL 50 Microfiltration CassettesThe Pellicon® XL 50 cassette couples Millipore's superior microfiltration membranes with the first truly linearly scalable TFF device for processing small volumes.
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Pellicon® 2 Ultrafiltration CassettesDesigned with process scale-up and applications development in mind.
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Pellicon® Mini Cassette HolderSimple design makes process development and small scale pharmaceutical manufacturing simple and efficient.
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Pellicon® Cassette Acrylic Holder and AssemblyThese acrylic holders operate a selection of Pellicon® Cassettes for tangential flow microporous filtration and ultrafiltration.
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Pellicon® Cassette Stainless Steel Holder and AssemblyDesigned for sanitary applications. Can be used to expand existing cassette ultrafiltration (CUF) systems or to replace existing holders in CUF systems.
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|Biopharmaceutical Manufacturing > Downstream Processing > Ultrafiltration > Pellicon Cassettes > Pellicon 2 Cassettes|
The Pellicon® 2 product line was designed with process scale-up and applications development in mind. The series of devices includes the long established Durapore® hydrophilic PVDF microfiltration membrane, well known for its exceptional combination of high flux, low protein binding and high product recoveries.
- Leading-edge void-free membranes to match virtually any separation challenge
- Short flow path for higher flux and higher resolution separation capability
- Choice of flow channel conﬁguration providing process optimization capability
- Predictable, fast, scale-up
- True linear scalability from laboratory size modules to industrial assemblies for processing thousands of liters
- Clarification – of protein solutions, polysaccharide solutions, virus suspensions/cultures, cell lysates and pre-column streams
- Harvesting – of cell cultures and colloidal suspensions
- Harvesting and Washing – of colloidal suspensions, bacterial cells or viral cultures
|Normalized Recirculation Rates|
|Screen Type||N/A||A C V|
|Recirculation Rate||L/min/m²||4/6 5/35|
|Differential Pressure||bar/psi||1.4/20 0.4/6|
|Screen Selection Guidelines|
|Solution Type||Screen Type|
|Dilute protein solution or low viscosity solutions (mAbs, interferons)||A screen
|Concentrated protein solutions or high viscosity solutions (IgG, biopolymers)||C screen
|High viscosity solutions (polysaccharides, certain microfiltration or clarification applications)||V screen
|Mini, Cassette and Maxi:||4 to 50 °C|
|Mini, Cassette and Maxi:||100 µm|
|Mini||5.6 cm||21 cm||1.5 cm (V screen-2.16 cm)|
|Cassette||17.8 cm||21 cm||1.5 cm (V screen-2.16 cm)|
|Maxi||17.8 cm||21 cm||7.6 cm (V screen-9.0 cm)|
|Membrane Selection Chart|
|Approximate Molecular Weight
(range of solutes retained > 99%, kD)
|Membrane||NMWL (kD) or Microns||Membrane Material||pH Range|
|Clarify cell lysates and protein solutions, clarify viral cultures||VVPP||0.1 µm||Hydrophilic PVDF||2 – 11|
|Harvest & wash colloidal suspensions, bacterial cells; clarify protein solutions and viral cultures||GVPP||0.22 µm||Hydrophilic PVDF||2 – 11|
|Harvest & wash colloidal suspensions, cell & viral cultures; clarify protein solutions & viral cultures||HVMP||0.45 µm||Hydrophilic PVDF||2 – 11|
|Harvest cell cultures or colloidal suspensions||DVPP||0.65 µm||Hydrophilic PVDF||2 – 11|