제품 이름
Opticap® XL 4 CapsuleMedia: Durapore® 0.22 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 9/16 in. Hose BarbMax Operating Pressure: 80 psi @ 25 °C
Quality Segment
material
PVDF , polyester support, polyethylene support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, silicone outer O-ring, silicone-coated EPDM rubber lead O-ring
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
gamma compatible
product line
Opticap® XL 4
feature
gamma compatible, hydrophilic
manufacturer/tradename
Opticap®
parameter
≤4.6 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, 2.8 bar max. differential pressure (40 psid) at 25 °C (Reverse; intermittent), 2.8 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 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
technique(s)
sterile filtration: suitable
L
7.7 in.
W
3.3 in.
cartridge nominal length
4 in. (10 cm)
diam.
6.1 cm (2.4 in.)
filtration area
0.18 m2
inlet connection diam.
1.5 in.
outlet connection diam.
9/16 in.
impurities
≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Durapore®
pore size
0.22 μm
input
sample type liquid
bubble point
≥3450 mbar (50 psig), air with water at 23 °C
fitting
General description
Packaging
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
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
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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705578-5MG-PW
PL860-CGA/SHF-1EA
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1000309185
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