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品質等級
法律遵循
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
製造商/商標名
OptiScale®
參數
25 °C max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure
直徑
6.9 cm (2.7 in.)
過濾面積
17.7 cm2
入口接頭直徑
1/4 in.
出口接頭直徑
1/4 in.
雜質
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
基質
Polygard®-CN
孔徑
30.0 μm nominal pore size
30.0 μm pore size
輸入
sample type liquid
接頭
inlet hose barb
6 mm (1/4 in.) inlet/outlet hose barb
outlet hose barb
一般說明
Device Configuration: 取样皿滤膜
特點和優勢
Format: Single Layer
其他說明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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
準備報告
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
分析報告
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL
法律資訊
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
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