KVGBA04TH3

Durapore^® 囊式过滤器 4 in.0.22 µm

Opticap^® XL 4, pore size 0.22 μm

• 别名: 疏水性Durapore^® 0.22 µm，Opticap^® XL囊式
• 分類程式碼代碼: 23151806
• eCl@ss: 32031690

属性

• 材料: PVDF
• 品質等級: 400
• 法律遵循: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible
• 產品線: Opticap^® XL 4
• 特點: hydrophobic
• 製造商／商標名: Durapore^®
• 參數: 25 °C max. inlet temp.; 80 psig max. inlet pressure
• 技術: sterile filtration: suitable
• 入口接頭直徑: 1.5 in.
• 出口接頭直徑: 9/16 in.
• 尺寸: 4 in.
• 雜質: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Durapore^®
• 孔徑: 0.22 μm pore size
• 接頭: (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

说明

一般說明

Device Configuration: 取样皿滤膜

其他說明

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.

準備報告

This product was manufactured with a Durapore^® 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.

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

免責聲明

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.