Quality Level
material
(Structural components: gamma compatible polypropylene), polyethersulfone membrane (hydrophilic), polyethylene support, polysulfone (core), silicone O-ring
reg. compliance
meets FDA Indirect Food Additive requirements cited in CFR 177-182 (all component materials)
sterility
non-sterile
sterilization compatibility
autoclavable compatible
gamma compatible
product line
Millipore Express®
feature
hydrophilic
sustainability
Greener Alternative Product
parameter
1000 mbar max. differential pressure (15 psi) at 80 °C, 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse; Intermittent), 5500 mbar max. differential pressure (80 psi) at 25 °C, 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward; Intermittent)
technique(s)
sterile filtration: suitable
D
5.6 cm (2.2 in.)
L
9.7 cm (3.8 in.)
filtration area
0.025 m2 (0.269 ft2)
impurities
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix
Millipore Express® Ace
pore size
0.2 μm pore size
bubble point
≥1320 mbar (19.1 psi), nitrogen with 70/30% IPA/water, ≥4140 mbar (60 psi), air with water
greener alternative category
General description
Application
This innovative membrane design means more membrane area for standard filter formats, resulting in exceptional filtration capacity with minimal footprint.
Features and Benefits
- High-capacity single layer membrane reducing the required membrane area
- Non cytotoxic to cells for upstream applications
- Easily wets to facilitate integrity testing
- High yields achieved due to low protein binding surface chemistry
- Made with non-per- and polyfluoroalkyl substances (PFAS) materials for enhanced sustainability
- Broad chemical compatibility making it suitable for use with ADCs
Packaging
Analysis Note
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology.
TOC/Conductivity
Irradiated filter effluent meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a water flush of: 2 L.
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 to the Opticap® XL and XLT Capsule User Guide.
- Storage Statement: Please refer to the Opticap® XL and XLT Capsule User Guide.
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
Legal Information
法规信息
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| KAFTG015FF3 | 04065272943239 |