CHVE71TF3

Millipore Express^® SHRP，小柱

with prefilter, cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm), Code 7

• 分類程式碼代碼: 23151806

屬性

• 材料: polypropylene support; seal (Fluorocarbon rubber)
• 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: Millipore Express^®
• 特點: hydrophilic; with prefilter
• 製造商／商標名: Millipore Express^®
• 參數: ≤27.1 mL/min air diffusion at 3.45 bar (50 psig) (in water); 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse); 0.35 bar max. differential pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward); 1000 mbar max. differential pressure (15 psi) at 135 °C (Forward); 1700 mbar max. differential pressure (25 psi) at 80 °C (Forward); 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse); 2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse); 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward); 69 mbar max. differential pressure (<1.0 psi) at 135 °C (Reverse); 6900 mbar max. differential pressure (100 psi) at 25 °C (Forward)
• 技術: sterile filtration: suitable
• 長度: 10 in.
• 寬度: 2.7 in.
• 柱標稱長度: 10 in. (25 cm)
• 過濾器直徑: 2.7 in. (6.9 cm)
• 過濾器尺寸: 10 in.
• 過濾面積: 0.48 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^® SHR (w/Prefilter)
• pore size: 0.5/0.1 μm pore size
• 起泡點: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water
• 柱代碼: Code 7

描述

一般說明

Cartridge Type: Liquid

Device Configuration: Cartridge

包裝

Double Easy-Open bag

準備報告

Sterilization Method: 25 forward or 22 forward and 3 reverse SIP cycles of 30 min at 135 °C, or 3 forward cycles, 30 min., 135 °C at ≤1000 mbar (15 psid); 25 autoclave cycles of 60 min at 126 °C

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

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

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