VPMG202NB1

Viresolve^® Pro デバイス

Parvovirus removal filter, Magnus 2.2 format, filtration area 1.53 m²

• 別名: Viresolve^® Pro Device Magnus 2.2
• UNSPSCコード: 23151806
• eCl@ss: 32031690

特性

• 物質: PVDF housing; polyethersulfone membrane; silicone gasket
• 品質水準: 400
• 製品種目: EMPROVE^® Filter
• メーカー／製品名: Viresolve^®
• パラメーター: 60 psig max. inlet pressure
• dilution: (Large volume processing)
• H: 9.50 cm (3.74 in.)
• L: 34.29 cm (13.50 in.)
• W: 20.96 cm (8.25 in.)
• デバイスサイズ: 2.2 in.
• ろ過面積: 1.53 m²
• 不純物: <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• フィッティング: 1.5 in. sanitary TC inlet/outlet fitting(s) (Disposable); 3/4 in. sanitary TC vent fitting for port (disposable)

詳細

詳細

The Viresolve^® Pro Solution provides a comprehensive, flexible template solution for viral clearance within mAb and recombinant protein bioproduction. This proven viral clearance solution delivers the highest levels of retention assurance and productivity across a broad range of feed stream characteristics.

Viresolve Pro Magnus Devices are typically used for filtration of mid to large scale batch volumes of proteins. The Viresolve^® Pro Device Magnus 2.2 offers a filtration area of 1.53 m² and has a primary use in large-volume processing.

特徴および利点

• Large scale manufacturing
• Two different size formats
• Integrated gaskets
• Units are stackable in the Viresolve^® Pro/Pro+ Magnus Holder (up to 7 units)
• Alignment keys on each unit to minimize errors during installation
• Fully disposable single-use fluid path
• Devices 100% tested with air/water diffusion and Binary Gas Test
• Shield / Shield H 100% aerosol tested

その他情報

これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。

Directions for Use

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

調製ノート

This product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

アナリシスノート

TOC/Conductivity
After a controlled water flush of 50 L/m², samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

法的情報

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

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

免責事項

EMD Millipore Corporationは本製品が欧州の圧力機器指令97/23/EC (1997年5月29日施行) に適合していることを証明します。本製品は圧力容器指令第3条3項に基づき分類されています。使用時の安全性を保証するため、適切なエンジニアリング方式に沿って設計・製造されています。本製品は圧力容器指令第3条3項に従い、CEマークは表示されていません。