KPGES3THH1

Opticap XLT 30 Millipore Express PHF 无菌 0.2 µm 5/8 in.HB

sterile, inlet connection diam. 5/8 in., cartridge nominal length 30 in. (75 cm)

• 同義詞: Millipore Express^® PHF, Opticap^® XLT 囊式
• 分類程式碼代碼: 23151806

屬性

• 材料: polyester support; polyethersulfone ; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; polysulfone ; 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: irradiated; sterile
• 產品線: Opticap^® XLT
• 特點: hydrophilic
• 製造商／商標名: Millipore Express^®
• 參數: ≤98.2 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1000 bar max. differential pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 5500 mbar max. differential pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• 技術: bioburden reduction: suitable
• 長度: 87.1 cm (34.3 in.)
• 柱標稱長度: 30 in. (75 cm)
• 直徑: 10.7 cm (4.2 in.)
• 過濾面積: 1.71 m²
• 入口接頭直徑: 5/8 in.
• 入口到出口寬度: 19.8 cm (7.8 in.)
• 出口接頭直徑: 5/8 in.
• 雜質: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Millipore Express^® PHF
• 孔徑: 0.2 μm
• 接頭: 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)

描述

一般說明

Device Configuration: 取样皿滤膜

T-line/Gauge Port: T-line

Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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 of Filters with MILLIPORE EXPRESS^® Membrane user guide
• Storage Statement: Please refer Filters with MILLIPORE EXPRESS^® Membrane user guide
• 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 @ 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 of membrane used in this filter 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 33 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 ≥4.5 L

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