Product Name
Polysep™ II 2.0/1.2 µm nominal, Opticap® XL Capsule, Opticap® XL 2, pore size 2.0/1.2 μm, cartridge nominal length 2 in. (5 cm), filter diam. 5.7 in. (14.5 cm)
material
borosilicate glass fiber (BGF) membrane
mixed cellulose esters (MCE) membrane
polypropylene filter
polypropylene housing
polypropylene support
silicone seal
reg. compliance
FDA 21CFR177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
product line
Opticap® XL 2
feature
hydrophilic
manufacturer/tradename
Opticap®
parameter
1 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure
technique(s)
prefiltration: suitable
cartridge nominal length
2 in. (5 cm)
device L
14.2 cm (5.6 in.)
device size
2 in.
filter diam.
5.7 in. (14.5 cm)
filter filtration area
0.06 m2
inlet connection diam.
3/4 in.
inlet to outlet width
14.2 cm (5.6 in.)
outlet connection diam.
9/16 in.
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.5 EU/mL 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
fitting
(19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)
Quality Level
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Analysis Note
Features and Benefits
General description
Other Notes
- 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
Packaging
Preparation Note
3 autoclave cycles of Sterilization Method: 30min at 121°C; not in-line steam sterilizable
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
Legal Information
Certificates of Analysis (COA)
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Global Trade Item Number
| SKU | GTIN |
|---|---|
| KGW9A02FH3 | 04053252559624 |
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