제품 이름
Opticap® XL 10 CapsuleMedia: Multimedia Durapore® 0.5 / 0.22 µm, Chemistry: Hydrophilic Mixed Cellulose Esters /Polyvinylidene Fluoride (MCE / PVDF)Inlet: 9/16 in. Hose BarbOutlet: 9/16 in. Hose BarbMax. Operating Pressure: 80 psi @ 25 °C
Quality Segment
material
PVDF , mixed cellulose esters (MCE) , mixed cellulose esters (MCE) prefilter, polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
product line
Opticap® XL 10
feature
hydrophilic
manufacturer/tradename
Opticap®
parameter
≤13.3 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water), 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 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 (Reverse; intermittent), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C, 80 psig max. inlet pressure, 80 °C max. temp.
technique(s)
sterile filtration: suitable
L
33.5 cm (13.2 in.)
W
4.2 in.
cartridge nominal length
10 in. (25 cm)
diam.
10.7 cm (4.2 in.)
filtration area
0.69 m2
inlet connection diam.
9/16 in.
outlet connection diam.
9/16 in.
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤50 mg/capsule
matrix
Multimedia Durapore®
pore size
0.5/0.22 μm pore size
input
sample type liquid
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
1/4 in. drain/vent hose barb (with double O-ring Seal), inlet hose barb, outlet hose barb, (14 mm (9/16 in.) Hose Barb Inlet and Outlet)
General description
Packaging
Preparation Note
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Analysis Note
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
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
Disclaimer
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저장 등급
4.1B - Flammable solid hazardous materials
wgk
WGK 3
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