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材料
polypropylene filter
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polypropylene support
silicone seal
品質等級
法律遵循
meets FDA 21 CFR 177-182 (all component materials)
製造商/商標名
Opticap®
參數
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
柱標稱長度
10 in. (25 cm)
設備尺寸
10 in.
過濾器長度
13.2 in. (33.5 cm)
過濾器直徑
4.2 in. (10.7 cm)
過濾器過濾面積
0.42 m2
入口接頭直徑
3/4 in. , sanitary flange
入口到出口寬度
33.5 cm (13.2 in.)
雜質
≤0.5 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
基質
Polygard®-CN
孔徑
0.3 μm pore size
接頭
inlet/outlet connection for 19 mm (3/4 in.) sanitary flange
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一般說明
Cartridge Type: Liquid
Device Configuration: Capsule
特點和優勢
Format: Single Layer
包裝
Double Easy-Open bag
準備報告
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
分析報告
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
其他說明
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
法律資訊
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
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