CHGE01HS

Millipore Express^® SHC High Area, Cartridge

cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm)

• 分類程式碼代碼: 23151806

屬性

• 材料: polyethersulfone device; polypropylene device; polypropylene support; silicone seal
• 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: EMPROVE^® Filter; Millipore Express^®
• 特點: hydrophilic
• 製造商／商標名: Millipore Express^®
• 參數: ≤56.4 mL/min air diffusion at 2.75 bar (40 psig) (in water); 1700 mbar max. differential pressure (25 psi) at 80 °C (Forward ); 1700 mbar max. inlet pressure (25 psi) at 80 °C (Forward ); 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse); 2100 mbar max. inlet pressure (30 psi) at 25 °C (Reverse); 340 mbar max. differential pressure (5 psi) at 135 °C (Forward ); 340 mbar max. inlet pressure (5 psi) at 135 °C (Forward ); 69 mbar max. differential pressure (1 psi) at 135 °C (Reverse); 69 mbar max. inlet pressure (1 psi) at 135 °C (Reverse); 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward ); 6900 mbar max. inlet pressure (100 psi) at 25 °C (Forward )
• 技術: sterile filtration: suitable
• 長度: 10 in.
• 寬度: 2.8 in.
• 柱標稱長度: 10 in. (25 cm)
• 過濾器直徑: 2.7 in. (6.9 cm)
• 過濾器過濾面積: 1.0 m²
• 雜質: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Millipore Express^® SHC High Area
• pore size: 0.5/0.2 μm pore size
• 起泡點: ≥4000 mbar (58 psig), air with water
• 柱代碼: Code 0

描述

一般說明

Device Configuration: Cartridge
Cartridge Type: Liquid

包裝

Double Easy-Open Bag

準備報告

This product was manufactured with a MILLIPORE EXPRESS^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析報告

TOC/Conductivity: After sterilization and a controlled water flush of 20 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.



Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

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 wetting instructions of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

法律資訊

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

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany