SVEPA25NB6

Millipore Express^® SHR, OptiScale^® Capsule

filtration area 3.5 cm², OptiScale^® 25

• 同義詞: Millipore Express SHR Optiscale 25mm 0.1 μm NB
• 分類程式碼代碼: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

屬性

• 材料: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• 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
• 產品線: OptiScale^® 25
• 特點: hydrophilic
• 製造商／商標名: Millipore Express^®
• 參數: 4.1 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• 技術: sterile filtration: suitable
• 長度: 3.9 cm (1.52 in.)
• 柱標稱長度: 1.52 in. (39 mm)
• 直徑: 3.1 cm (1.2 in.)
• 過濾面積: 3.5 cm²
• 雜質: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Millipore Express^® SHR
• 孔徑: 0.1 μm
• 接頭: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)
• 運輸包裝: ambient

描述

一般說明

Device Configuration: 取样皿滤膜

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 installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer to OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

準備報告

Sterilization Method
1 autoclave cycle of 60 min @ 123 °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

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

法律資訊

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

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

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