K003A05FF1

Opticap^® XL Capsule Filter

pore size 0.3 μm, cartridge nominal length 5 in. (12.5 cm), filter diam. 4.2 in. (10.7 cm)

• 分類程式碼代碼: 23151806

属性

• 材料: polypropylene filter; polypropylene housing; polypropylene support; silicone seal
• 品質等級: 400
• 法律遵循: meets FDA 21 CFR 177-182 (all component materials)
• 製造商／商標名: Opticap^®
• 參數: max. inlet temp. at 25 °C; 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• 柱標稱長度: 5 in. (12.5 cm)
• 設備尺寸: 5 in.
• 過濾器長度: 8.5 in. (21.6 cm)
• 過濾器直徑: 4.2 in. (10.7 cm)
• 入口接頭直徑: 3/4 in. , sanitary flange
• 入口到出口寬度: 21.6 cm (8.5 in.)
• 雜質: ≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)
• 基質: Clarigard^®
• 孔徑: 0.3 μm pore size
• 接頭: inlet/outlet connection for 19 mm (3/4 in.) sanitary flange

说明

一般說明

Cartridge Type: Liquid

Device Configuration: Capsule

包裝

Double Easy-Open bag

準備報告

Sterilization Method:
3 autoclave cycles of 30min at 126°C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21CFR210.3(b)(6).

分析報告

Gravimetric Extractables: ≤ 55mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2L

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

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

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