제품 이름
Opticap® XLT 10 CapsuleMedia: Multilayer Durapore® 0.45 / 0.22 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 5/8 in. Hose BarbT-lineMax Operating Pressure: 80 psi @ 25 °C
Quality Segment
material
polypropylene filter, polypropylene housing, polypropylene support, silicone seal
reg. compliance
FDA 21CFR177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
gamma compatible
feature
hydrophilic
manufacturer/tradename
Opticap®
parameter
≤15.0 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 1 bar max. inlet pressure (15 psi) at 80 °C, 1.05 bar max. differential pressure (15 psid) at 80 °C (Forward:), 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 (Reverse; intermittent), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward:), 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure
cartridge nominal length
10 in. (25 cm)
device L
37.6 cm (14.8 in.)
device size
10 in.
filter diam.
4.2 in. (10.7 cm)
filter filtration area
0.11 m2
inlet connection diam.
1-1/2 in.
inlet to outlet width
17.5 cm (6.9 in.)
outlet connection diam.
5/8 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Multilayer Durapore®
pore size
0.22 μm pore size, 0.45 μm pore size
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
16 mm (5/8 in.) fitting (hose barb inlet/oulet), 38 mm (1 1/2 in.) fitting (sanitary flange inlet/oulet), 1/4 in. fitting (vent/drain hose barb with double O-ring seal)
General description
Packaging
Preparation Note
Gamma compatible to 45 kGy; 3 autoclave cycles of 60min at 3°C; not in-line steam sterilizable
This product was manufactured with a Durapore® membrane 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 Wetting Instructions for Filter Units with Durapore® Membrane 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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