CVHL52PP3

Durapore^® 0.45 µm，小柱

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 5

• UNSPSC代码: 23151806

属性

• 物料: polypropylene device; polypropylene support; silicone seal
• 管理合规性: meets EU 1935/2004/EC (all component materials; regarding materials and articles intended to contact food); meets FDA 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: ≤30 mL/min air diffusion at 1.5 bar (22 psig) (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); 3.5 bar max. inlet temp. (50 psi) at 25 °C (reverse); 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: bioburden reduction: suitable
• 长度: 20 in.
• 宽度: 2.7 in.
• 纯化柱标称长度: 20 in. (50 cm)
• 设备尺寸: 20 in.
• 过滤器直径: 2.7 in. (6.9 cm)
• 过滤器过滤面积: 1.38 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: ≤20 mg/cartridge
• 基质: Durapore^®
• 孔径: 0.45 μm pore size
• 泡点: ≥1930 mbar (28 psig), air with water
• 代码: Code 5

说明

一般描述

Device configuration: Cartridge
Cartridge type: Liquid

包装

Double Easy-Open bag

制备说明

Sterilization Method: 30 SIP cycles of 30 min at 135°C; 30 autoclave cycles of 60 min at 126°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

Gravimetric Extractables: The extractables level was ≤ 20 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 ≥ 2 L

其他说明

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 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

法律信息

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