PCC030C10G

Pellicon^® Capsule with Ultracel^® Membrane

pore size 30 kDa, C Screen, 1 m² manifold with AseptiQuik^® G connectors

• Synonim(y): Pellicon^® Capsule with Ultracel^® Membrane, Pellicon^® Ultracel^® TFF Capsule, Single-Use 30kDa Pellicon^® Ultracel^® Capsule
• UNSPSC Code: 41104903
• eCl@ss: 27301809

Właściwości

• Nazwa produktu: Pellicon^® Capsule 1 m² Ultracel^® 30 kDa C Screen,
• Quality Segment: 400
• material: EPDM rubber seal, PPO/PS blend housing, TPE seal, cellulose screen (Composite Regenerated), composite regenerated cellulose (CRC) membrane, epoxy adhesive, epoxy device (Potting, BPA-free), polyester screen, polypropylene screen, polyurethane adhesive, polyurethane device (Pottin)
• description: C Screen, 1 m² manifold with AseptiQuik^® G connectors
• sterility: sterile; γ-irradiated
• product line: Pellicon^®
• parameter: max. inlet pressure at 75 psi (5.1 bar) and 4-30 °C, max. transmembrane pressure at 50 psi (3.5 bar) and 4-30 °C, 4-8 L/min-m² flow rate
• technique(s): tangential flow filtration (TFF): suitable, ultrafiltration: suitable
• capsule L × W × H: 19.56 cm (7.7 in.) × 34.37 cm (13.53 in.) × 40.46 cm (15.93 in.)
• hold-up volume: 254 mL , feed channel, 306 mL , permeate channel
• membrane area: 1 m²
• screen H: 15.9 in. (40.5 cm)
• screen L: 7.7 in. (19.6 cm) , Length
• screen W: 13.5 in. (34.4 cm)
• impurities: ≤5 ppm Meets 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^® G Connector), inlet/outlet connection (Permeate: AseptiQuik^® G Connector), inlet/outlet connection (Retentate: AseptiQuik^® G Connector)
• application(s): mAb; recombinant protein
• storage temp.: 15-25°C

Opis

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^® composite membranes are engineered to deliver low fouling and low protein binding, enabling high product retention, recovery, and yield in tangential flow filtration processes. They support efficient concentration and diafiltration of a 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

A foam pouch 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 then placed on a tray and individually boxed.

Other Notes

Screen Type: Type C screen (coarse screen)

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

Ta strona może zawierać tekst przetłumaczony maszynowo.