제품 이름
Opticap® XLT 10 Capsule Media: Milligard® 0.5 / 0.2 µm Nominal, Chemistry: Mixed Cellulose Esters (MCE) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange T-line with 3/4 in. Gauge Port T-line side Max Operating Pressure: 80 psi @ 25 °C
Quality Segment
material
mixed cellulose esters (MCE) membrane, polyester support, polypropylene filter, polypropylene housing, silicone seal
reg. compliance
FDA 21CFR177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
product line
Opticap® XLT 10
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
10 in. (25 cm)
device size
10 in.
inlet connection diam.
1-1/2 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
Milligard®
pore size
0.5/0.2 μm nominal pore size, 0.5/0.2 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 installation section of Opticap® XL Capsules and Opticap® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
Legal Information
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