material
TPE seal, polyethersulfone membrane, polypropylene housing, polypropylene screen, stainless steel cap (for end; polypropylene-encapsulated)
manufacturer/tradename
Pellicon®
storage condition
do not freeze
parameter
30 psi max. reverse press. exposure at 25 °C (for 24 hours), 4-6 L/min-m2 recirculation rate, 4-8 L/min-m2 flow rate, 40 psi max. transmembrane pressure at 4-50 °C, 6.9 bar max. inlet pressure (100 psi), 80 psi max. transmembrane pressure at 4-40 °C
technique(s)
tangential flow filtration (TFF): suitable, ultrafiltration: suitable
H
4.2 cm (1.67 in.)
L
20.6 cm (8.1 in.)
W
17.8 cm (7 in.)
filtration area
1.14 m2
size
229 mL , Volume (feed), 88 mL , Volume (permeate)
gravimetric extractables
≤1500 mg/m2
matrix
Biomax®
pore size
(30 kDa)
pH
1-14
storage temp.
2-8°C
Quality Level
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General description
Pellicon® 3 cassettes with Biomax membrane are the optimum tangential flow filtration (TFF) devices for the filtration of solutions containing therapeutical proteins, albumin, hormones, vaccines and growth factors. These advanced, high-performance cassettes are ideal for today’s higher titer therapeutic antibodies, higher viscosity feed formulations as well as the more demanding filtration processes that require higher operating pressures, temperatures and caustic cleaning regimes.From small-scale to full-scale production, Pellicon® 3 cassettes are designed for use in research, process scale-up/scale-down, applications development and full-scale manufacturing. The Pellicon® 3 design and automated manufacturing process provides unbeatable performance consistency between cassette sizes. Pellicon® 3 devices also offer greater cassette size selection for improved scale-up and scale-down process development. The streamlined design allows operators to quickly and easily handle, install and remove Pellicon® 3 cassettes. The materials of construction are compatible with a broad range of chemical cleaning.
Application
monoclonal antibodies, recombinant and non-recombinant proteins, vaccines
Features and Benefits
- Robust, void-free membrane provides optimum productretention and performance consistency
- Unique feed screen design enables high mass transfer, flux for higher finalconcentration
- Fast, reliable scale up/down from lab to production scale
- Automated manufacturing delivers unbeatable performance consistency andreliability
- Easy to install and clean
- Extreme temperature and chemical compatibility
Analysis Note
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Other Notes
These products are manufactured in a facility which adheres to Good Manufacturing Practices.
Legal Information
BIOMAX is a registered trademark of Merck KGaA, Darmstadt, Germany
Pellicon is a registered trademark of Merck KGaA, Darmstadt, Germany
存储类别
10 - Combustible liquids
wgk
WGK 1
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