material
borosilicate glass fiber (BGF) membrane, mixed cellulose esters (MCE) membrane, polypropylene device, polypropylene support (spun bonded), silicone seal
reg. compliance
meets FDA 21 CFR 177–182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
steam-in-place compatible
product line
Polysep™
feature
hydrophilic
manufacturer/tradename
Polysep™ II
parameter
3.5 bar max. differential pressure (50 psid) at 25 °C
technique(s)
prefiltration: suitable
L
40 in.
W
2.7 in.
cartridge nominal length
40 in. (100 cm)
device size
40 in.
filter diam.
2.8 in.
filter filtration area
1.84 m2
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Polysep™ II
pore size
2.0/1.2 μm nominal pore size, 2.0/1.2 μm pore size
cartridge code
Code 0
Quality Level
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General description
Device Configuration: Cartridge
Cartridge Type: Liquid
Filter Grade: Prefilter
Cartridge Type: Liquid
Filter Grade: Prefilter
Application
mAb & r-protein intermediates; Plasma; Vaccines & viral vectors; SVPs LVPs; Cell Culture; Media Filtration; Colloid Removal; Lipid Removal
Features and Benefits
Format: Double Layer
Packaging
Double Easy-Open bag
Preparation Note
This product was manufactured with a Millipore® media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min
Sanitization: 30 min with hot water at 80 °C
Analysis Note
After autoclaving and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature, extractables level was ≤140 mg per 10-inch element after a 5000 mL flush.
Cartridges meet the requirements of the USP Oxidizable Substances Test after a water flush of 5000 mL per 10 inch Element
Other Notes
Directions for Use:
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer first page of Visual Inspection Guide and introduction section of Mixed cellulose esters Tech Brief
- Storage Statement: Please refer Mixed cellulose esters Tech Brief
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
The product is manufuactured in a facility with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard.
Legal Information
Polysep is a trademark of Sigma-Aldrich Co. LLC
Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
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