Innovative single-use tangential flow filtration (TFF) devices for streamlined bioprocessing
Innovative single-use tangential flow filtration (TFF) devices for streamlined bioprocessing Less
Material Qualification Dossier
Quality Management Dossier (Open Access)
Operational Excellence Dossier
|Pellicon® Capsules with Ultracel® Membrane|
|User Guide Pellicon® Capsule and Pellicon® Capsule Stand|
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|Biopharmaceutical Manufacturing > Downstream Processing > Ultrafiltration > Pellicon® Ultrafiltration > Pellicon® Capsules with Ultracel® Membrane > Pellicon® Capsules|
The Pellicon® Capsule is the first of its kind -- a true single-use TFF device that comes ready to process in minutes. Self-contained, it employs an easy-to-use, holderless format and is supplied gamma sterilized with preservative-free reverse osmosis water.
This new addition to the Pellicon® family shares the same unbeatable performance of Pellicon® cassettes and are linearly scalable, making it easy to transition between both formats.
Pellicon® Capsules are ideal for the filtration of solutions that require single-use capabilities, including
- Rapid batch turnaround for higher plant productivity
- Lower risks of product cross-contamination
- Self-contained device for increased operator safety
- Process flexibility for multi-product manufacturing facilities
- Optimum use of time and resources from minimal device preparation
Pellicon® Capsules with Ultracel® membrane are designed for excellent product retention, recovery, and high yields. Ultracel® void-free composite membranes combine ultra-low protein binding, low fouling, and organic solvent resistance with superb mechanical strength.
- Plug ’n play, holderless design -- easy to install, safe to remove
- Gamma sterilized and preservative-free -- ready to process in minutes
- True single-use, self-contained capsule -- fast, safe, and flexible batch turnaround
- Proven Ultracel® membrane and C screen -- high recovery, superior mass transfer, solvent resistance
- Pellicon® TFF proven performance -- true linear scalability within Pellicon® TFF families
- Antibody drug conjugates
- Monoclonal and bispecific antibodies
- mRNA and plasmids
- Viral vectors and viral vaccines
- Recombinant and non-recombinant proteins
The Pellicon® Capsule Stand is specially designed to conveniently support up to two 0.1 m2 capsules in parallel or three in series on one side and one 0.5 m2 capsule or one 1 m2 manifold on the opposite side.
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
|Materials of Construction|
|Membrane:||Composite Regenerated Cellulose (Ultracel®)|
|Internal Seals:||EPDM, Thermoplastic Elastomer|
|Potting:||BPA-free epoxy, Polyurethane|
|Storage Solution and Temperature|
|Storage Solution:||Reverse osmosis water, preservative-free|
|30 kDa||100, 300 kDa|
|Recommended Feed Flow Rate:||4 – 8 L/min per m2||4 - 6 L/min/m2|
|Maximum Inlet Pressure:||Filter only: 80 psi (5.5 bar) at 4-30 °C
Filter with Connectors or 1 m2 Manifold: 75 psi (5.1 bar) at 4-30 °C
3 & 4.5 m2 Manifolds: 60 psi (4.1 bar) at 4-30 °C
|Maximum Forward Transmembrane Pressure:||50 psi (3.45 bar) at 4 - 30 °C||45 psi (3.1 bar) at 4 - 30 °C|
|pH Range:||2 - 13|
|Component Material Toxicity:||All materials in the fluid path meet the criteria of the ISO 10993-5 Cytotoxicity MEM Elution Test|
|Good Manufacturing Practice:||This product was manufactured in a facility that adheres to current Good Manufacturing Practices.|
|ISO 9001 Quality Standard:||This product was manufactured in a facility whose Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality System Standard.|
|100% Integrity Tested in Manufacturing||Each unit must pass our integrity test based on air flow through the fully wetted membrane of the filter, and housing leak integrity test.|
|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.|