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Merck

KHVEG2TTB1H

Millipore

Millipore Express® SHR High Area with prefilter 0.5/0.1µm, Opticap® XLT 20 Capsule

Fittings 1-1/2 in. TC- 1 in. HB, Gamma Compatible

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About This Item

UNSPSCコード:
23151806

製品名

Millipore Express® SHRP High Area, Opticap® XLT Capsule, Opticap® XLT 20, cartridge nominal length 20 in. (50 cm), filter diam. 4.2 in. (10.7 cm)

物質

polyester support
polypropylene housing
polypropylene vent cap (gamma stable)
silicone seal

品質水準

法規制遵守

meets FDA 21 CFR 177-182 (all component materials)

無菌性

non-sterile

滅菌適合性

gamma compatible

製品種目

Opticap® XLT 20

特徴

hydrophilic

メーカー/製品名

Millipore Express®

パラメーター

≤108.4 mL/min air diffusion at 3.45 bar (50 psig) (in water)
0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse)
1 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet pressure
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
80 psig max. inlet pressure

テクニック

sterile filtration: suitable

L

24.6 in.

W

7.8 in.

カートリッジの長さ(公称)

20 in. (50 cm)

フィルタ直径

4.2 in. (10.7 cm)

フィルタサイズ

20 in.

ろ過面積

2.0 m2

不純物

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)

Matrix

Millipore Express® SHR ((w/Prefilter High Area))

pore size

0.5/0.1 μm pore size

泡立ち点

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

フィッティング

1/4 in. drain/vent connection ( hose barb with double o-ring seal)
(38 mm (1 1/2 in.) Sanitary Flange Inlet and 25 mm (1 in.) Hose Barb Outlet)

アプリケーション

filtration

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特徴および利点

T-line/Gauge Port: T-line

包装

Double Easy-Open bag

調製ノート

Sterilization Method: Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min at 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).

アナリシスノート

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4 L

TOC/Conductivity: After sterilization and a controlled water flush of 40 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.

その他情報

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.

法的情報

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

試験成績書(COA)

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