材料
polypropylene device
polypropylene support
silicone seal
品質等級
無菌
non-sterile
滅菌相容性
autoclavable compatible
steam-in-place compatible
產品線
Lifegard™
特點
hydrophilic
製造商/商標名
Lifegard™
參數
3.5 bar max. differential pressure (50 psid) at 25 °C
3.5 bar max. inlet pressure (50 psi) at 25 °C
技術
prefiltration: suitable
長度
40 in.
寬度
2.7 in.
柱標稱長度
40 in. (100 cm)
設備尺寸
40 in.
過濾器直徑
2.9 in. (7.4 cm)
過濾面積
1.84 m2
雜質
≤1.0 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<1.0 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量法萃取物
≤250 mg/cartridge
基質
Lifegard™
孔徑
1.0 μm nominal pore size
1.0 μm pore size
代碼
Code 0
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一般說明
Device configuration: Cartridge
Cartridge type: Liquid
Cartridge type: Liquid
特點和優勢
Format: Single Layer
包裝
Double Easy-Open bag
規格
Filter Grade: AP15
準備報告
Sterilization Method: 10 autoclave cycles or SIP at 121°C for 30 min
分析報告
Gravimetric Extractables: The extractables level was ≤ 250 mg per 10-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
其他說明
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
法律資訊
Lifegard is a trademark of Merck KGaA, Darmstadt, Germany
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