产品名称
Optiscale®囊式过滤器Polygard® CN, filtration area 17.7 cm2, pore size 10.0 μm
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)
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.
1/4 in.
outlet connection diam.
1/4 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
matrix
Polygard®-CN
pore size
10.0 μm nominal pore size
10.0 μm pore size
input
sample type liquid
fitting
inlet hose barb
6 mm (1/4 in.) inlet/outlet hose barb
outlet hose barb
Quality Level
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General description
Device Configuration: 取样皿滤膜
Analysis Note
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL
Features and Benefits
Format: Single Layer
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.
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
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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