产品名称
Opticap XL3 Millipore Express SHF 可γ辐照 0.2 µm 1-1/2 in.TC/TC, inlet connection diam. 1.5 in., Opticap® XL, cartridge nominal length 3 in. (7.5 cm)
material
polyester support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
polysulfone
polyethersulfone membrane
silicone O-ring
silicone seal
feature
hydrophilic
manufacturer/tradename
Millipore Express®
Quality Level
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
gamma compatible
x-ray compatible
product line
Opticap® XL
parameter
1.0 bar max. differential pressure (15 psi) at 80 °C
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.8 bar max. inlet pressure (40 psi) at 60 °C
5.5 bar max. differential pressure (80 psi) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
technique(s)
sterile filtration: suitable
W
4.2 in.
cartridge nominal length
3 in. (7.5 cm)
device L
17.3 cm (6.8 in.)
filter diam.
10.7 cm (4.2 in.)
filtration area
0.17 m2 (1.8 ft2)
inlet connection diam.
1.5 in.
inlet to outlet W
17.3 cm (6.8 in.)
outlet connection diam.
1.5 in.
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Millipore Express® SHF
pore size
0.2 μm
bubble point
≥4000 mbar (58 psig), air with water at 23 °C
fitting
38 mm (1 1/2 in.) inlet sanitary flange
38 mm (1 1/2 in.) outlet sanitary flange
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 3.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
General description
Disclaimer
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.
Packaging
Preparation Note
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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