PCC100C05C

Pellicon^® Capsule with Ultracel^® Membrane

pore size 100 kDa, C Screen, 0.5 m² with AseptiQuik^® G Connectors

• Synonym(e): Pellicon^® Capsule with Ultracel^® Membrane, Pellicon^® Ultracel^® TFFCapsule, Single-Use Pellicon^® Ultracel^® Capsule
• UNSPSC Code: 41104903

Eigenschaften

• Produktname: Pellicon^® Kapsel mit Ultracel^® Membran, Feed: AseptiQuik^® G Connector Retentate: AseptiQuik^® G Connector Permeate: AseptiQuik^® G Connector
• Quality Segment: 400
• material: EPDM rubber seal, PPO/PS blend (core), PPO/PS blend housing, TPE seal, composite regenerated cellulose (CRC) membrane, epoxy adhesive, polyester screen, polypropylene screen, polyurethane adhesive
• sterility: sterile; γ-irradiated
• product line: Pellicon^®
• storage condition: room temperature (15-30°C)
• parameter: 4-6 L/min-m² flow rate, 45 psi max. transmembrane pressure (3.1 bar) at 4-30 °C (Forward), 75 psi max. inlet pressure (5.1 bar) at 4 - 30 °C
• technique(s): ultrafiltration: suitable
• L: 41.1 cm (16.2 in.)
• diam.: 5.7 cm (2.3 in.)
• filtration area: 0.5 m²
• screen size: , Type C screen (coarse screen)
• volume: 130 mL , in feed channel, 139 mL , in permeate channel
• impurities: ≤5 ppm Meets TOC (in retentate effluent, after a WFI flush of 20 L/m²)
• matrix: Ultracel^®
• pore size: 100 kDa
• pH range: 2-13
• fitting: inlet/outlet connection (Feed: AseptiQuik^® G Connector), inlet/outlet connection (Permeate: AseptiQuik^® G Connector), inlet/outlet connection (Retentate: AseptiQuik^® G Connector)
• application(s): mAb; recombinant protein

Beschreibung

General description

Pellicon^® Capsules with Ultracel^® membrane is the first of its kind, a true single use TFF device designed to support efficient concentration and diafiltration of therapeutic biologics. Their high flux membrane technology, optimized feed channel design, and spiral wound configuration enable rapid processing, high productivity, and reliable scalability from process development to manufacturing. The integrated C feed channel screen promotes optimal flow dynamics to maximize filtration performance and support high concentration applications.

Application

Pellicon^® Capsules with Ultracel^® compositemembranes are engineered to deliver low fouling and low protein binding,enabling high product retention, recovery, and yield in tangential flowfiltration processes. They support efficient concentration and diafiltration ofa broad range of biologics, including:

• Antibody drug conjugates
• Monoclonal and bispecific antibodies
• mRNA and plasmids
• Viral vectors and viral vaccines
• Recombinant and non-recombinant proteins

Features and Benefits

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

Packaging

A foam clamshell is inserted over the end caps on both ends of the capsule which is then double-bagged and vacuum sealed. The double-bagged capsule is placed on a tray and then individually boxed.

Other Notes

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.

Legal Information

AseptiQuik is a registered trademark of Colder Products Company

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Pellicon is a registered trademark of Merck KGaA, Darmstadt, Germany

ULTRACEL is a registered trademark of Merck KGaA, Darmstadt, Germany