CVSC02TP3

多介质 Durapore^® 1.2/0.5/0.22 µm, 筒式

cartridge nominal length 20 in. (50 cm), filter diam. 2.7 in. (6.9 cm), Code 0

• 分類程式碼代碼: 23151806

屬性

• 材料: mixed cellulose esters (MCE) prefilter; polypropylene device; polypropylene support; silicone seal
• 品質等級: 400
• 法律遵循: meets FDA 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^®
• 參數: ≤21.6 mL/min air diffusion at 2.75 bar (40 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; intermittent); 3.5 bar max. inlet temp. (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)
• 技術: sterile filtration: suitable
• 長度: 20 in.
• 寬度: 2.7 in.
• 柱標稱長度: 20 in. (50 cm)
• 設備尺寸: 20 in.
• 過濾器直徑: 2.7 in. (6.9 cm)
• 過濾面積: 1.12 m²
• 雜質: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量法萃取物: ≤70 mg/cartridge
• 基質: Multimedia Durapore^®
• pore size: 1.2/0.5/0.22 μm pore size
• 起泡點: ≥3450 mbar (50 psig), air with water
• 代碼: Code 0

描述

一般說明

Device configuration: Cartridge
Cartridge type: Liquid

包裝

Double Easy-Open bag

準備報告

Sterilization Method: 6 autoclave or SIP cycles of 30 min at 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: The extractables level was ≤ 70 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 ≥ 10 L

其他說明

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

法律資訊

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

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