产品名称
Optiscale®囊式过滤器Polygard® CN, Max Pressure: 80 psi @ 25 °C
material
PVDF vent cap, fluoroelastomer FKM seal, polycarbonate , polypropylene , polypropylene support
reg. compliance
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
matrix
Polygard®-CN
pore size
2.5 μm nominal pore size, 2.5 μm pore size
input
sample type liquid
fitting
inlet sanitary flange, 19 mm (3/4 in.) inlet/outlet sanitary flange, outlet sanitary flange
Quality Level
manufacturer/tradename
OptiScale®
parameter
25 °C max. inlet temp., 5.5 bar max. inlet pressure (80 psi) at 25 °C, 80 psig max. inlet pressure
diam.
6.9 cm (2.7 in.)
filtration area
17.7 cm2
inlet connection diam.
3/4 in.
outlet connection diam.
3/4 in.
General description
Device Configuration: 取样皿滤膜
Features and Benefits
Format: Single Layer
Preparation Note
Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Analysis Note
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL
Other Notes
Directions for Use:
- Organism Retention: Bacterial
- Mode of Action: Filtration (size exclusion)
- Appliication: Protein Purification
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer to the installation and wetting sections of OptiScale® 47 Capsulle Filter with Polygard® CN Media user guide
- Storage Statement: Store in original packaging at room temperature
- Disposal Statement: Dispose of in accordance with applicable federal, state, and local regulations
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Legal Information
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
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