产品名称
Opticap XL 150 Millipore Express SHF 可γ辐照 0.2 µm 3/4 in.TC-9/16 in.HB,
material
polyethersulfone , polyethylene support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, polysulfone , silicone seal
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 150
Quality Level
feature
gamma compatible, hydrophilic
manufacturer/tradename
Millipore Express®
parameter
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 100 psi max. differential pressure (6.9 bar) (intermittent), 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent), 2.75 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, 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent), 80 psi max. differential pressure (5.5 bar) (continuous), 80 psig max. inlet pressure
technique(s)
sterile filtration: suitable
L
9.7 cm (3.8 in.)
W
2.2 in.
cartridge nominal length
3.8 in. (9.7 cm)
diam.
5.6 cm (2.2 in.)
filtration area
220 cm2
inlet connection diam.
9/16 in.
inlet to outlet W
9.7 cm (3.8 in.)
outlet connection diam.
9/16 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Millipore Express® SHF
pore size
0.2 μm pore size
bubble point
≥4000 mbar (58 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)
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General description
Packaging
Preparation Note
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °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.
After sterilization and a controlled water flush of 2.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
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
Disclaimer
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