製品名
オプティスケール(OptiScale)® カプセルフィルター ポリガード(Polygard)®-CN, Max Pressure: 80 psi @ 25 °C
Quality Segment
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.
3/4 in.
outlet connection diam.
3/4 in.
impurities
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
matrix
Polygard®-CN
pore size
30.0 μm nominal pore size, 30.0 μm pore size
input
sample type liquid
fitting
inlet sanitary flange, 19 mm (
General description
Device Configuration: カプセル
Features and Benefits
Format: Single Layer
Preparation Note
Sterilization Method
126 °C 60 分のオートクレーブ滅菌3回; インライン蒸気滅菌不可
126 °C 60 分のオートクレーブ滅菌3回; インライン蒸気滅菌不可
Analysis Note
次の水でフラッシング後USP Oxidizable Substances Testに適合 ≥100 mL
Other Notes
これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。
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
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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