SVPVSMLNB9

Optiscale^® 25 Viresolve^® NFP病毒过滤器

Parvovirus removal

• 同義詞: OptiScale-25 with Viresolve NFP Validation Kit, single membrane lot
• 分類程式碼代碼: 23151806
• eCl@ss: 32031690

屬性

• 材料: PVDF (modified); silicone seal
• 製造商／商標名: OptiScale^®
• 參數: 0.7 bar max. differential pressure (10 psid) (Reverse); 5.5 bar max. differential pressure (80 psid) (Forward); 70 mL process volume
• 技術: protein purification: suitable
• 長度: 2.2 cm (0.87 in.)
• 過濾面積: 3.5 cm²
• 雜質: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Viresolve^® NFP
• 接頭: female Luer-Lok^® inlet connection; male Luer outlet slip

描述

一般說明

Device Configuration: Validation Kit

應用

Parvovirus removal

其他說明

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

Directions for Use

• Organism Retention: Parvovirus
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Viral clearance
• Instructions for Use: Please refer ′Installation and Operation′ section of the user guide shipped with this product
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

準備報告

Sterilization Method
Water wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min

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

法律資訊

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

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

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