CLGL02TP3

Durapore II 筒式过滤器 20 in.0.22 µm 0 号

pore size 0.22 μm, cartridge nominal length 20 in. (50 cm), Code 0 (2-222; O-rings)

• 别名: Durapore^® 0.22 µm, 高面积，小柱
• 分類程式碼代碼: 23151806
• eCl@ss: 27293007

属性

• 材料: PVDF
• 品質等級: 400
• 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: 0.22 μm pore size
• 輸入: sample type liquid
• 柱代碼: Code 0 (2-222; O-rings)

说明

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.

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