CW0604S03

Milligard^® 0.5 µm nominal, Cartridge

cartridge nominal length 40 in. (100 cm), filter diam. 2.8 in. (7.1 cm)

• 分類程式碼代碼: 23151806

属性

• 材料: polyester support; polypropylene device; silicone seal
• 品質等級: 400
• 法律遵循: meets EU 1935/2004/EC (alll component materials); meets FDA 21 CFR 177-182 (all component materials)
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible; steam-in-place compatible
• 產品線: Milligard^®
• 特點: hydrophilic
• 製造商／商標名: Milligard^®
• 參數: 3.5 bar max. differential pressure (50 psid) at 25 °C; 3.5 bar max. inlet pressure (50 psi) at 25 °C
• 技術: prefiltration: suitable
• 長度: 40 in.
• 寬度: 2.9 in.
• 柱標稱長度: 40 in. (100 cm)
• 過濾器直徑: 2.8 in. (7.1 cm)
• 過濾器過濾面積: 3.2 m²
• 過濾器尺寸: 40 in.
• 雜質: ≤0.5 EU/mL bacterial endotoxins (LAL test, aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Milligard^®
• 孔徑: 0.5 μm nominal pore size; 0.5 μm pore size
• 柱代碼: Code 0

说明

一般說明

Cartridge Type: Liquid

Device Configuration: Cartridge

Filter Grade: Standard MILLIGARD^® Media

特點和優勢

Format: Single Layer

包裝

Double Easy-Open bag

準備報告

Sterilization Method: 10 autoclave cycles or SIP at 121 °C for 30 min

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析報告

Gravimetric Extractables: The extractables level was ≤50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.   

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 and wetting sections of OPTISCALE^® -25 user guide and introduction section of Mixed cellulose esters Tech Brief
• Storage Statement: Please refer Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

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

法律資訊

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

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