材料
PVDF
品質等級
法律遵循
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
無菌
non-sterile
滅菌相容性
autoclavable compatible
steam-in-place compatible
產品線
Durapore®
特點
hydrophilic
製造商/商標名
Durapore® II
技術
sterile filtration: suitable
長度
20 in.
寬度
2.7 in.
柱標稱長度
20 in. (50 cm)
過濾面積
2.2 m2
雜質
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量法萃取物
≤60 mg/cartridge
基質
Durapore® High Area
孔徑
0.1 μm pore size
輸入
sample type liquid
柱代碼
Code 7 (2-226; O-rings w/locking-tabs)
一般說明
Device Configuration: Cartridge
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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
準備報告
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析報告
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after a 1.5 L flush and 24 hours in water at controlled room temperature
法律資訊
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
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