Material Qualification Dossier
Quality Management Dossier
|Pellicon® Capsules with Ultracel® Membrane (MilliporeSigma)|
|User Guide Pellicon® Capsule and Pellicon® Capsule Stand|
Pellicon® 2 Ultrafiltration CassettesDesigned with process scale-up and applications development in mind.
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Pellicon® XL 50 Microfiltration CassettesThe Pellicon<sup>®</sup> 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® 3 CassettesAdvanced, high performance cassettes ideally suited to today's demanding filtration processes that require more rigorous operating pressures, temperatures and caustic cleaning regimes
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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
- Monoclonal antibodies
- Antibody drug conjugates
- Recombinant and non-recombinant proteins
The Pellicon® Capsule Stand is specially designed for convenience during use. It accommodates up to two 0.1 m2 capsules in parallel or three 0.1 m2 capsules in series on one side and one 0.5 m2 capsule 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|
|Recommended Feed Flow Rate:||4 – 8 L/min per m²|
|Maximum Inlet Pressure:||80 psi (5.52 bar) at 4 - 30°C|
|Maximum Forward Transmembrane Pressure:||50 psi (3.45 bar) at 4 - 30°C|
|pH Range:||2 - 13|
|Component Material Toxicity:||Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics.|
|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 integrity.|
|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.|