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Key Documents

CPGE71TF3

Millipore

Millipore Express PHF 筒式过滤器 10 in.0.2 µm 7 号氟碳橡胶

pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), Code 7, fluoroelastomer seal

别名:

Millipore Express® PHF,小柱

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About This Item

分類程式碼代碼:
23151806
eCl@ss:
32031690

材料

fluoroelastomer seal
polyethersulfone
polypropylene
polypropylene support
polysulfone

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
steam-in-place compatible

產品線

Millipore Express®

特點

hydrophilic

製造商/商標名

Millipore Express®

參數

≤30 mL/min air diffusion at 2.76 bar (40 psig) and 23 °C (in water)
0.07 bar max. differential pressure (1 psid) at 135 °C (Reverse)
0.35 bar max. differential pressure (5 psid) at 135 °C (Forward)
1.0 psi max. differential pressure (69 mbar) at 135 °C (Reverse)
1.4 bar max. differential pressure (20 psid) at 25 °C (Reverse)
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
20 psi max. differential pressure (1.4 bar) at 25 °C (Reverse)
25 psi max. differential pressure (1.7 bar) at 80 °C (Forward)
5.0 psi max. differential pressure (340 mbar) at 135 °C (Forward)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)

技術

bioburden reduction: suitable

長度

10 in.

寬度

2.7 in.

柱標稱長度

10 in. (25 cm)

直徑

6.9 cm (2.7 in.)

過濾面積

0.54 m2

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 pore size

輸入

sample type liquid

柱代碼

Code 7

一般說明

Device Configuration: Cartridge

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
12 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 15 autoclave cycles of 60 min @ 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

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 10 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 ≥1 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

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