제품 이름
Opticap® XL 5 CapsuleMedia: Polysep™ II 1.0 / 1.2 µm Nominal, Chemistry: Mixed Cellulose Esters (MCE)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeMax Operating Pressure: 80 @ 25 °C
Quality Segment
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 5
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
5 in. (12.5 cm)
device L
21.6 cm (8.5 in.)
device size
5 in.
filter diam.
5.7 in. (14.5 cm)
filter filtration area
0.19 m2
inlet connection diam.
1-1/2 in.
inlet to outlet width
21.6 cm (8.5 in.)
outlet connection diam.
1-1/2 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
1.0/1.2 μm nominal pore size, 1.2/1.0 μm pore size
fitting
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
General description
Features and Benefits
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).
Analysis Note
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
Legal Information
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