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Key Documents

SHVEA25NB6

Millipore

Millipore Express SHR 带预滤器 Optiscale 25mm 0.5/0.1 µm NB

OptiScale® 25, filtration area 3.5 cm2, pore size 0.5/0.1 μm

同義詞:

Millipore Express® SHRP,OptiScale®囊式

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031690
NACRES:
NB.24

材料

polyethersulfone membrane
polypropylene
polypropylene support
polypropylene vent cap

品質等級

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

OptiScale® 25

特點

hydrophilic

製造商/商標名

Millipore Express®

參數

4.1 bar max. inlet pressure (60 psi) at 25 °C
60 psi max. differential pressure (4.1 bar) at 25 °C (forward)

技術

sterile filtration: suitable

長度

3.9 cm (1.52 in.)

寬度

1.21 in.

柱標稱長度

1.52 in. (39 mm)

直徑

3.1 cm (1.2 in.)

過濾面積

3.5 cm2

雜質

≤0.25 EU/mL (LAL test, Aqueous extraction)
<0.25  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

基質

Millipore Express® SHR (w/Prefilter)

pore size

0.5/0.1 μm pore size

接頭

female Luer-Lok® inlet connection
male Luer-Lok® outlet connection
(Female Luer-Lok® Inlet/Male Luer Slip Outlet)

運輸包裝

ambient

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 and wetting sections of OPTISCALE®-25 user guide
  • Storage Statement: Please refer to OPTISCALE®-25 user guide
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

準備報告

Sterilization Method
1 autoclave cycle of 60 min @ 123 °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

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.
This product was tested and passes the USP <78> test for particulates in injectables.

法律資訊

Luer-Lok is a registered trademark of Becton-Dickinson & Co.
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OptiScale is a registered trademark of Merck KGaA, Darmstadt, Germany

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儲存類別代碼

10-13 - German Storage Class 10 to 13


分析證明 (COA)

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