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 23 °C
80 psig max. inlet pressure
纯化柱标称长度
5 in. (12.5 cm)
device size
5 in.
filter L
8.5 in. (21.6 cm)
过滤器直径
4.2 in. (10.7 cm)
入口接头直径
9/16 in. , hose barb
inlet to outlet width
21.6 cm (8.5 in.)
杂质
≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
基质
Clarigard®
孔径
0.2 μm pore size
配件
inlet/outlet connection for 14 mm (9/16 in.) hose barb
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一般描述
Cartridge Type: Liquid
Device Configuration: Capsule
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
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).
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 ≥2L
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 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
CLARIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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