KVGLS2THH1

Durapore^® 0.22 µm，Opticap^® XLT囊式

Opticap^® XLT 20, cartridge nominal length 20 in. (50 cm), filter diam. 4.2 in. (10.7 cm)

• 分類程式碼代碼: 23151806

屬性

• 材料: polyester support; polyethylene support; polypropylene filter (Gamma-stable); polypropylene housing; silicone seal
• 品質等級: 400
• 法律遵循: FDA 21CFR177-182 (all component materials)
• 無菌: sterile; irradiated
• 產品線: Opticap^® XLT 20
• 特點: hydrophilic
• 製造商／商標名: Opticap^®
• 參數: ≤28 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1 bar max. inlet pressure (15 psi) at 80 °C; 1.7 bar max. differential pressure (25 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: 20 in. (50 cm)
• 設備長度: 62.5 cm (24.6 in.)
• 設備尺寸: 20 in.
• 過濾器直徑: 4.2 in. (10.7 cm)
• 過濾器過濾面積: 0.62 m²
• 入口接頭直徑: 5/8 in.
• 入口到出口寬度: 19.8 cm (7.8 in.)
• 出口接頭直徑: 5/8 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: 0.22 μm pore size
• 起泡點: ≥3450 mbar (50 psig), air with water at 23 °C
• 接頭: 16 mm (5/8 in.) fitting (hose barb inlet/oulet); 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (16 mm (5?8 in.) Hose Barb Inlet and 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 3°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: ≤ 50 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 ≥ 2 L

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