物料
polypropylene device
polypropylene support
silicone seal
制造商/商品名称
Lifegard™
参数
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
纯化柱标称长度
4 in. (10 cm)
设备尺寸
4 in.
过滤器直径
2.9 in. (7.4 cm)
过滤器过滤面积
0.16 m2
杂质
≤1.0 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<1.0 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量萃取物
≤100 mg/cartridge
基质
Lifegard™
孔径
1.0 μm nominal pore size
1.0 μm pore size
代码
Code N
一般描述
Device configuration: Cartridge
Cartridge type: Liquid
Cartridge type: Liquid
特点和优势
Filter Grade: AP15
Format: Single Layer
包装
Double Easy-Open bag
制备说明
Sterilization Method: 10 autoclave cycles or SIP at 121°C for 30 min
分析说明
Gravimetric Extractables: The extractables level was ≤ 100 mg per 4-inch cartridge after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 L
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 5 L
其他说明
Directions for Use:
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer to Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
法律信息
Lifegard is a trademark of Merck KGaA, Darmstadt, Germany
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