Description
Pellicon 3 cassettes with Millipore’s Ultracel® PLC membranes are the optimum tangential flow filtration (TFF) devices for the filtration of monoclonal antibodies and other therapeutic proteins. These advanced, high-performance cassettes are ideal for today’s higher titer therapeutic antibodies as well as the more demanding filtration processes that require higher operating pressures, temperatures and caustic cleaning regimes.
From small-scale to full-scale production, Pellicon 3 cassettes are designed for use in research, process scale-up/scale-down, applications development and full-scale manufacturing. The Pellicon 3 design and automated manufacturing process provides unbeatable performance consistency and enhanced linear scalability between cassette sizes. Pellicon 3 also offers greater cassette size selection for improved scale-up and scale-down process development. The streamlined design allows operators to quickly and easily handle, install and remove Pellicon 3 cassettes. The materials of construction are compatible with a broad range of chemical cleaning agents that many TFF systems require to ensure proper sanitization.
Rugged, reliable design ideally suited to filtration processes with higher operating pressures, temperatures and caustic cleaning regimes
• Automated manufacturing delivers unbeatable performance consistency and reliability
• Optimum product recovery using proven composite membrane technology
• Easy to install and clean
Typical Applications
• Monoclonal antibodies
• Recombinant and non-recombinant proteins
Optimum Product Recovery and High Yields
Ultracel composite membranes offer low fouling and low protein binding for excellent product retention, recovery and higher yields. Ultracel membranes are constructed of regenerated cellulose membrane cast on a microporous substrate for defect-free membranes with superior robustness compared to conventional membranes. The composite technology offers a mechanically robust design able to withstand process upsets and extreme operating conditions.
Fast, Reliable Linear Scale-Up from the Lab to the Production Plant
Offered in four sizes, 88 cm2, 0.11m2, 0.57 m2 and 1.14 m2, all Pellicon 3 cassettes are constructed of identical materials and have the same flow channel length, height, turbulence promoter and flow direction. This ensures that every Pellicon 3 cassette maintains the same performance profile at every scale, from 250 milliliters to thousands of liters.
![M928104-06[54362-ALL].jpg](/images/medium/M928104-06[54362-ALL].jpg)
Pellicon 3 Cassette (88 cm<sup>2</sup>)
![M928105-06[54363-ALL].jpg](/images/medium/M928105-06[54363-ALL].jpg)
Pellicon 3 Cassette (0.11 m<sup>2</sup>)
![M934813-06[54365-ALL].jpg](/images/medium/M934813-06[54365-ALL].jpg)
Pellicon 3 Cassette (0.57 m<sup>2</sup> and 1.14<nbsp/>m<sup>2</sup>)
Streamlined Installation and Rugged Design
Pellicon 3 cassettes incorporate a hard polypropylene jacket and end cap design that protects the membrane surface from impacts and potential damage. The end cap includes integral seals which simplify the installation by eliminating the need for external gaskets between each device.
Reliable Product Performance Delivering Exceptional Consistency and Reproducibility
Millipore’s controlled automated manufacturing process provides the highest level of cassette performance consistency. The high level of process control ensures consistent, repeat performance in terms of scale up to scale down, from run to run and campaign to campaign. All cassettes are manufactured in accordance with GMP.
Extreme Temperature and Chemical Capability
Pellicon 3 cassettes are manufactured using the most modern polymers and plastics enabling continuous operation at 50 °C and 0.5N NaOH up to 50 hours.* These materials of construction ensure low extractables in a wide range of solvents, acids and bases.
* Contact Millipore for additional information.
Quality Assurance
All Pellicon 3 cassettes are manufactured using the same equipment, process and quality assurance. Each Pellicon 3 cassette manufacturing lot is 100% integrity tested during manufacturing to ensure that every filter is integral, robust and within specification. Additionally, Pellicon 3 cassettes are subjected to a complete array of quality control release tests.
Each cassette is identified with a unique serial number and shipped with an individual Certificate of Quality.
Hold Up Volume
| Area | Feed
Channel (mL) | Permeate
Channel
(mL) | Membrane
and Support
(mL) | Total after
Feed Channel
Blow Down (mL) |
| 88 cm2 | 1.4 | 2.4 | 2.5 | 5 |
| 0.11 m2 | 18 | 15 | 21.5 | 36.5 |
| 0.57 m2 | 85 | 68 | 107 | 175 |
| 1.14 m2 | 170 | 127 | 193 | 320 |
| Materials and Assembly |
| Materials of construction | Polyethylene |
| Thermoplastic elastomer |
| Stainless Steel end cap |
| 0.57 m2 and 1.14 m2 cassettes only | Polypropylene |
| Membrane | Composite Regenerated Cellulose |
| Assembly Design | Automated assembly and testing of heat sealed packets bound together by an injected molded polypropylene jacket. |
| Operating Conditions |
| Recommended Feed Flow Rate, L/min | 4–8 per m2 |
| Maximum Operating Pressure/Temperature, bar (psi) | 2.75 (40) @ 50 °C; 5.5 (80) @ 40 °C |
| Maximum Reverse Pressure, bar (psi) | 2 (30) |
| Maximum Caustic Concentration | 0.5N NaOH up to 50 hours (Contact Millipore for exposure parameters) |
| Operating pH Range | 2–13 |
| Regulatory Information |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. |
| Good Manufacturing Practices | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
| ISO® 9001 Quality Standard | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
| 100% Integrity Tested in Manufacturing | Each unit must pass the Millipore integrity test based on air flow through the fully-wetted membranes of the filter. |
| Validated Production Process | This product was fabricated using a validated manufacturing process. Principles of statistical process control and determinations of process capability have been applied to critical variables in the device fabrication process. In-process controls are used to assure stability of the process. |
