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Opticap^® XL胶囊过滤器

cartridge nominal length 10 in. (25 cm), filter diam. 4.2 in. (10.7 cm)

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: gamma compatible
• 特點: hydrophilic
• 製造商／商標名: Opticap^®
• 參數: ≤15.0 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; 1.05 bar max. differential pressure (15 psid) at 80 °C (Forward:); 2.75 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
• 柱標稱長度: 10 in. (25 cm)
• 設備長度: 37.6 cm (14.8 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: 0.11 m²
• 入口接頭直徑: 1-1/2 in.
• 入口到出口寬度: 17.5 cm (6.9 in.)
• 出口接頭直徑: 5/8 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: Multilayer Durapore^®
• 孔徑: 0.22 μm pore size; 0.45 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); 38 mm (1 1/2 in.) fitting (sanitary flange inlet/oulet); 1/4 in. fitting (vent/drain hose barb with double O-ring seal)

描述

一般說明

Device Configuration: Capsule

包裝

Double Easy-Open bag

準備報告

Sterilization Method:
Gamma compatible to 45 kGy; 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.

TOC/Conductivity: After sterilization and a controlled water flush, samples exhibited less than 500ppb TOC per USP < 643 > and less than 1.3μS/cm per USP < 645 > at 25°C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1.5 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