제품 이름
Opticap® XLT 30 CapsuleMedia: Durapore® 0.45 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-lineMax Operating Pressure: 80 psi @ 25 °C
Quality Segment
material
polyester support, polyethylene support, polypropylene filter, polypropylene housing, silicone seal
reg. compliance
FDA 21CFR177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
gamma compatible
product line
Opticap® XLT 30
feature
hydrophilic
manufacturer/tradename
Opticap®
parameter
≤45.0 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water), 1 bar max. inlet pressure (15 psi) at 80 °C, 2.1 bar max. differential pressure (30 psid) at 4-40 °C (Reverse:), 2.8 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward:), 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure
technique(s)
bioburden reduction: suitable
W
6.0 in.
cartridge nominal length
34.3 in. (87.1 cm)
device L
87.1 cm (34.3 in.)
device size
30 in.
filter diam.
4.2 in. (10.7 cm)
filter filtration area
1.86 m2
inlet connection diam.
1-1/2 in.
inlet to outlet width
87.1 cm (34.3 in.)
outlet connection diam.
1-1/2 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Durapore®
pore size
0.45 μm pore size
bubble point
≥1930 mbar (28 psig), air with water at 23 °C
fitting
General description
Preparation Note
This product was manufactured with a Durapore® membrane which meets the criteria for a ′non-fiber releasing′ filter as defined in 21 CFR 210.3 (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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1000309185
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