材料
borosilicate glass fiber (BGF)
polypropylene
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
20 in.
寬度
2.7 in.
柱標稱長度
20 in. (50 cm)
直徑
7.4 cm (2.9 in.)
過濾面積
0.92 m2
雜質
≤1.0 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.1 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量法萃取物
≤440 mg/cartridge
基質
Lifegard™
孔徑
2.0 μm nominal pore size
2.0 μm pore size
輸入
sample type liquid
柱代碼
Code 0 (2-222; O-rings)
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一般說明
Device Configuration: Cartridge
特點和優勢
Format: Single Layer
包裝
Double Easy-Open bag
其他說明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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 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.
規格
Filter Grade: AP20
準備報告
Sanitization Protocol
30 min with hot water @ 80 °C
30 min with hot water @ 80 °C
Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min
10 autoclave cycles or SIP @ 121 °C for 30 min
分析報告
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
法律資訊
Lifegard is a trademark of Merck KGaA, Darmstadt, Germany
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