KVEPS006FB3

Millipore Express^®SHR, Opticap^® XL 囊式

sterile, Opticap^® XL 600, cartridge nominal length 6.5 in. (16.5 cm), filter diam. 5.6 cm (2.2 in.)

• 分類程式碼代碼: 23151806

屬性

• 材料: polyethylene support; polypropylene device; polypropylene housing; polypropylene vent cap; silicone seal
• 品質等級: 400
• 法律遵循: meets FDA 21 CFR 177-182 (all component materials)
• 無菌: irradiated; sterile
• 產品線: Opticap^® XL 600
• 特點: hydrophilic
• 製造商／商標名: Millipore Express^®
• 參數: ≤5.8 mL/min air diffusion at 3.45 bar (50 psig) (in water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 100 psi max. differential pressure (6.9 bar) (intermittent); 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• 技術: sterile filtration: suitable
• 柱標稱長度: 6.5 in. (16.5 cm)
• 設備長度: 16.5 cm (6.5 in.)
• 過濾器直徑: 5.6 cm (2.2 in.)
• 過濾器過濾面積: 1010 cm²
• 雜質: ≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (sample aqueous extraction)
• 基質: Millipore Express^® SHR
• 孔徑: 0.1 μm pore size
• 起泡點: ≥4000 mbar (58 psig), air with water
• 接頭: (19 mm (¾ in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet with filling bell)

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 60 min at 123 °C; not in-line steam sterilizable

This product was manufactured with a MILLIPORE EXPRESS^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (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 of 3.0 L, samples exhibited &#x3C 500 ppb TOC per USP &#x3C 643 &#x3C and &#x3C 1.3 μS/cm per USP &#x3C 645 &#x3C at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 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 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

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

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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