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Merck

CVEP01TS3

Millipore

Millipore Express® SHR,小柱

cartridge nominal length 10 in. (25 cm), filter diam. 2.7 in. (6.9 cm)

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About This Item

分類程式碼代碼:
23151806

材料

polypropylene support
silicone seal

法律遵循

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

Millipore Express®

特點

hydrophilic

製造商/商標名

Millipore Express®

參數

≤33.3 mL/min air diffusion at 3.45 bar (50 psig) (in water)
0.35 bar max. differential pressure (5 psi) at 135 °C (Forward)
1.7 bar max. differential pressure (25 psi) at 80 °C (Forward)
1700 mbar max. differential pressure (25 psi) at 80 °C (Forward)
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent)
2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse)
340 mbar max. differential pressure (5 psi) at 135 °C (Forward)
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
69 mbar max. differential pressure (<1.0 psi) at 135 °C (Reverse)
6900 mbar max. differential pressure (100 psi) at 25 °C (Forward)

技術

sterile filtration: suitable

長度

10 in.

寬度

2.7 in.

柱標稱長度

10 in. (25 cm)

過濾器直徑

2.7 in. (6.9 cm)

過濾器過濾面積

0.6 m2

過濾器尺寸

10 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® SHR

孔徑

0.1 μm

起泡點

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water

柱代碼

Code 0

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一般說明

Cartridge Type: Liquid
Device Configuration: Cartridge

包裝

Double Easy-Open bag

準備報告

Sterilization Method: 25 forward or 22 forward and 3 reverse SIP cycles of 30 min at 135 °C; 25 autoclave cycles of 60 min at 126 °C

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

TOC/Conductivity: After sterilization and a controlled water flush of 10 L, samples exhibited <500 ppb TOC per USP 643 and <1.3 μS/cm per USP 645 at 25 °C.

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.

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 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

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

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

分析證明 (COA)

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