PCC030C45E

Pellicon^® Capsule with Ultracel^® Membrane

30 kDa, C Screen, 4.5 m² manifold extender with AseptiQuik^® L connectors

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

Properties

• Product Name: Pellicon^® Capsule 4.5 m² Ultracel^® 30 kDa C Screen, Feed: AseptiQuik^® L Connector Retentate: AseptiQuik^® L Connector Permeate: AseptiQuik^® L 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: 4-8 L/min-m² flow rate, 50 psi pressure (3.5 bar) at 4-30 °C (Forward Transmembrane Pressure (TMP)), 60 psi max. pressure (4.1 bar) at 4-30 °C (Maximum Inlet Pressure)
• technique(s): ultrafiltration: suitable
• H: 46.9 cm (18.5 in.)
• L: 60.2 cm (23.7 in.)
• W: 48.2 cm (19.0 in.)
• filtration area: 4.5 m²
• screen size: , Type C screen (coarse screen)
• volume: 1857 mL , in feed channel, 2403 mL , in permeate channel
• impurities: ≤5 ppm TOC ( in retentate effluent, after a WFI flush of 20 L/m²)
• matrix: Ultracel^®
• pore size: 30 kDa
• pH range: 2-13
• fitting: inlet/outlet connection (Feed: AseptiQuik^® L Connector), inlet/outlet connection (Permeate: AseptiQuik^® L Connector), inlet/outlet connection (Retentate: AseptiQuik^® L Connector)
• application(s): mAb; recombinant protein

Description

General description

Pellicon^® Capsules with Ultracel^® membrane is thefirst of its kind, a true single use TFF device designed to support efficientconcentration and diafiltration of therapeutic biologics. Their high fluxmembrane technology, optimized feed channel design, and spiral woundconfiguration enable rapid processing, high productivity, and reliablescalability from process development to manufacturing. The integrated C feedchannel screen promotes optimal flow dynamics to maximize filtrationperformance 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 preseravtive-free - ready to process in minutes
True single-use, self-contained capusle - 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

The manifold assembly is inserted into a polyethylene foam frame and then double bagged and vacuum sealed. The double-bagged assembly is placed within a second foam frame and individually boxed (qty 1 per box). Packaged assemblies are palletized.

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