KPHLA04FF3

Durapore^® 0.45 µm，Opticap^® XL囊式

Opticap^® XL 4, inlet connection diam. 3/4 in., cartridge nominal length 4 in. (10 cm)

• 同義詞: Opticap XL4 Durapore 0.45 m without prefilter 3/4 in. TC/TC
• 分類程式碼代碼: 23151806

屬性

• 材料: PVDF ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• 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: hydrophilic
• 製造商／商標名: Opticap^®
• 參數: ≤4.5 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.4 bar max. differential pressure (50 psid) at 25 °C (Forward); 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• 技術: bioburden reduction: suitable
• 長度: 7.7 in.
• 寬度: 3.3 in.
• 柱標稱長度: 4 in. (10 cm)
• 直徑: 8.4 cm (3.3 in.)
• 過濾面積: 0.19 m²
• 入口接頭直徑: 3/4 in.
• 入口到出口寬度: 18.8 cm (7.4 in.)
• 出口接頭直徑: 3/4 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)
• 重量法萃取物: ≤10 mg/capsule
• 基質: Durapore^®
• 孔徑: 0.45 μm
• 輸入: sample type liquid
• 起泡點: ≥1930 mbar (28 psig), air with water at 23 °C
• 接頭: 1/4 in. drain/vent hose barb (with double O-ring Seal); inlet sanitary flange; outlet sanitary flange; (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

描述

一般說明

Device Configuration: 取样皿滤膜

包裝

Double Easy-Open bag

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 Wetting Instructions for Filter Units with Durapore^® Membrane 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

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable

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

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

法律資訊

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.