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物料
polypropylene filter
polypropylene housing
polypropylene support
silicone seal
质量水平
管理合规性
meets FDA 21 CFR 177-182 (all component materials)
制造商/商品名称
Opticap®
参数
max. inlet temp. at 25 °C
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure
纯化柱标称长度
10 in. (25 cm)
设备尺寸
10 in.
过滤器长度
13.2 in. (33.5 cm)
过滤器直径
4.2 in. (10.7 cm)
过滤器过滤面积
0.42 m2
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一般描述
Cartridge Type: Liquid
Device Configuration: Capsule
特点和优势
Format: Single Layer
包装
Double Easy-Open bag
制备说明
Sterilization Method:
3 autoclave cycles of 30min at 126°C; not in-line steam sterilizable
3 autoclave cycles of 30min at 126°C; not in-line steam sterilizable
分析说明
Gravimetric Extractables: ≤ 55mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5L
其他说明
Directions for Use:
- Organism Retention: Microorganism reduction
- Mode of Action: Filtration (size exclusion)
- Applicaiton: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer to 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
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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