CVSS01TP3

Durapore 多介质筒式过滤器 10 in.0.5+0.2+0.22 µm 0 号

pore size 0.5/0.2/0.22 μm, cartridge nominal length 10 in. (25 cm), Code 0 (2-222; O-rings)

• 别名: 多介质Durapore^® 0.5/0.2/0.22 µm，筒式
• UNSPSC代码: 23151806
• eCl@ss: 32031690

属性

• 物料: PVDF ; mixed cellulose esters (MCE) ; mixed cellulose esters (MCE) prefilter; polypropylene ; polypropylene support; silicone seal
• 质量水平: 400
• 管理合规性: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 无菌性: non-sterile
• 灭菌适用性: autoclavable compatible; steam-in-place compatible
• 产品线: Durapore^®
• 特点: hydrophilic
• 制造商/商品名称: Durapore^®
• 参数: ≤10.8 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse; Intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• 技术: sterile filtration: suitable
• 长度: 10 in.
• 宽度: 2.7 in.
• 纯化柱标称长度: 10 in. (25 cm)
• 直径: 6.9 cm (2.7 in.)
• 过滤面积: 0.56 m²
• 杂质: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量萃取物: ≤70 mg/cartridge
• 基质: Multimedia Durapore^®
• pore size: 0.5/0.2/0.22 μm pore size
• 输入: sample type liquid
• 泡点: ≥3450 mbar (50 psig), air with water at 23 °C
• 柱代码: Code 0 (2-222; O-rings)

说明

一般描述

Device Configuration: Cartridge

包装

Double Easy-Open bag

其他说明

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.

制备说明

Sterilization Method
6 autoclave or SIP cycles of 30 min @ 123 °C

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).

分析说明

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 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

法律信息

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

安全信息

• 储存分类代码: 11 - Combustible Solids
• WGK: WGK 2