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Millipore Express^® SHC 0.5/0.2µm, Opticap^® XLT 10 Capsule

Fittings 5/8 in. HB, Sterile

• 别名: Millipore Express^® SHC，Opticap^® XLT囊式
• UNSPSC代码: 23151806

属性

• 产品名称: Opticap 无菌 XLT 10 Millipore Express SHC 0.5/0.2 µm 5/8 in.HB, Opticap^® XLT 10, sterile, inlet connection diam. 5/8 in., pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm)
• 物料: polyester support; polyethersulfone ; polypropylene ; polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• 质量水平: 400
• 管理合规性: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 无菌性: irradiated; sterile
• 产品线: Opticap^® XLT 10
• 特点: hydrophilic
• 制造商/商品名称: Millipore Express^®
• 参数: ≤31.2 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (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 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• 技术: sterile filtration: suitable
• 长度: 37.6 cm (14.8 in.)
• 纯化柱标称长度: 10 in. (25 cm)
• 直径: 10.7 cm (4.2 in.)
• 过滤面积: 0.54 m²
• 入口接头直径: 5/8 in.
• 入口至出口宽度: 19.8 cm (7.8 in.)
• 出口接头直径: 5/8 in.
• 杂质: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基质: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• 泡点: ≥4000 mbar (58 psig), air with water at 23 °C
• 配件: 1/4 in. drain/vent hose barb (with double O-ring seal); inlet hose barb; outlet hose barb; (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

说明

一般描述

Device Configuration: 取样皿滤膜

T-line/Gauge Port: T-line

包装

Double Easy-Open bag

其他说明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

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.

制备说明

Sterilization Method
3 autoclave cycles of 60 min @ 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).

分析说明

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 21 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

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

法律信息

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

免责声明

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.