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物料
polypropylene
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
Opticap®
参数
25 °C max. inlet temp.
80 psig max. inlet pressure
纯化柱标称长度
30 in. (75 cm)
入口接头直径
1.5 in.
出口接头直径
1.5 in.
杂质
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量萃取物
≤165 mg/capsule
基质
Polygard®-CN
孔径
10.0 μm nominal pore size
10.0 μm pore size
输入
sample type liquid
配件
inlet sanitary flange
outlet sanitary flange
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一般描述
Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line
其他说明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
- Organism Retention: Microorganism reduction
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
分析说明
Gravimetric Extractables: after 24 hours in water at controlled room temperature
法律信息
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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