物料
PVDF vent cap
fluoroelastomer FKM seal
polycarbonate
polypropylene
polypropylene support
质量水平
管理合规性
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
制造商/商品名称
OptiScale®
参数
25 °C max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure
直径
6.9 cm (2.7 in.)
过滤面积
17.7 cm2
入口接头直径
1/4 in.
出口接头直径
1/4 in.
杂质
≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
基质
Polygard®-CN
孔径
30.0 μm nominal pore size
30.0 μm pore size
输入
sample type liquid
配件
inlet hose barb
6 mm (1/4 in.) inlet/outlet hose barb
outlet hose barb
相关类别
一般描述
Device Configuration: 取样皿滤膜
特点和优势
Format: Single Layer
其他说明
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
制备说明
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
分析说明
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥100 mL
法律信息
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
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