KPHLS10TT1

Durapore^® 0.45 µm，Opticap^® XL囊式

Opticap^® XL 10, cartridge nominal length 13.2 in. (33.5 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; polypropylene housing; silicone outer O-ring; silicone-coated EPDM rubber lead O-ring
• 品質等級: 400
• 法律遵循: FDA 21CFR177-182 (all component materials)
• 無菌: sterile; irradiated
• 產品線: Opticap^® XL 10
• 特點: hydrophilic
• 製造商／商標名: Opticap^®
• 參數: ≤15.0 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; 2.1 bar max. differential pressure (30 psid) at 4-40 °C (Reverse:); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward:); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• 技術: bioburden reduction: suitable
• 柱標稱長度: 13.2 in. (33.5 cm)
• 設備長度: 33.5 cm (13.2 in.)
• 設備尺寸: 10 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: 1-1/2 in.
• 入口到出口寬度: 33.5 cm (13.2 in.)
• 出口接頭直徑: 1-1/2 in.
• 雜質: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Durapore^®
• 孔徑: 0.45 μm pore size
• 起泡點: ≥1930 mbar (28 psig), air with water at 23 °C
• 接頭: 1/4 in. fitting (vent/drain hose barb with double O-ring seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

描述

一般說明

Device Configuration: Capsule

準備報告

Sterilization Method:
Gamma compatible to 40 kGy. 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

Gravimetric Extractables: ≤ 25 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 ≥ 1500 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 installation section of Opticap^® XL Capsules and Opticap^® XLT Capsules 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

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

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