KVVLA02FH3

Durapore^® 0.1 µm，Opticap^® XL囊式

Opticap^® XL 2, cartridge nominal length 2 in. (5 cm), filter diam. 5.7 in. (14.5 cm)

• 分類程式碼代碼: 23151806

屬性

• 材料: polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• 品質等級: 400
• 法律遵循: FDA 21CFR177-182 (all component materials)
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible
• 產品線: Opticap^® XL 2
• 特點: hydrophilic
• 製造商／商標名: Opticap^®
• 參數: ≤3.5 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water); 1 bar max. inlet pressure (15 psi) at 80 °C; 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward:); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward:); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• 技術: sterile filtration: suitable
• 柱標稱長度: 2 in. (5 cm)
• 設備長度: 14.0 cm (5.5 in.)
• 設備尺寸: 2 in.
• 過濾器直徑: 5.7 in. (14.5 cm)
• 過濾器過濾面積: 0.2 m²
• 入口接頭直徑: 3/4 in.
• 入口到出口寬度: 14 cm (5.5 in.)
• 出口接頭直徑: 9/16 in.
• 雜質: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Durapore^®
• 孔徑: 0.1 μm pore size
• 起泡點: ≥4830 mbar (70 psig), air with water at 23 °C
• 接頭: 19 mm (3/4 in.) fitting (sanitary flange inlet/oulet); 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

描述

一般說明

Device Configuration: Capsule

包裝

Double Easy-Open bag

準備報告

Sterilization Method:
3 autoclave cycles of 60min at 126°C; not in-line steam sterilizable

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(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.

Gravimetric Extractables: ≤ 10 mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 500 mL

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 for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

法律資訊

ASTM is a registered trademark of American Society for Testing and Materials

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

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