CHVE71TE3

Millipore Express SHR 筒式过滤器 10 in.0.5/0.1 µm 7 号 EPDM

pore size 0.5/0.1 μm, cartridge nominal length 10 in. (25 cm), Code 7, EPDM rubber seal

• 别名: Millipore Express^® SHRP，小柱
• 分類程式碼代碼: 23151806
• eCl@ss: 32031690

属性

• 材料: EPDM rubber seal; polyethersulfone ; polypropylene ; polypropylene support; polysulfone
• 品質等級: 400
• 法律遵循: meets FDA Indirect Food Additive requirements cited in 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
• 製造商／商標名: Millipore Express^®
• 參數: ≤27.1 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); <1.0 psi max. differential pressure (69 mbar) at 135 °C (reverse); 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); 100 psi max. differential pressure (6.9 bar) at 25 °C (forward); 15 psi max. differential pressure (1.0 bar) at 135 °C (forward); 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse); 25 psi max. differential pressure (1.7 bar) at 80 °C (forward); 30 psi max. differential pressure (2.1 bar) at 25 °C (reverse); 6.9 bar 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)
• 直徑: 6.9 cm (2.7 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
• 輸入: sample type liquid
• 起泡點: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• 柱代碼: Code 7

说明

一般說明

Device Configuration: Cartridge

包裝

Double Easy-Open bag

其他說明

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 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.

準備報告

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

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

TOC/Conductivity
After sterilization and a controlled water flush of 20 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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

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