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Key Documents

CGEP71TE3

Millipore

Cartucho Millipore Express® SHF

pore size 0.2 μm, cartridge nominal length 10 in. (25 cm), EPDM rubber seal

Sinônimo(s):

Millipore Express SHF Cartridge Filter 10 in. 0.2 μm Code 7 EPDM

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About This Item

Código UNSPSC:
23151806
eCl@ss:
32031690

Materiais

EPDM rubber seal
polyethersulfone
polypropylene
polypropylene support
polysulfone

Nível de qualidade

conformidade reg.

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

esterilidade

non-sterile

Compatibilidade de esterilização

autoclavable compatible
steam-in-place compatible

linha de produto

EMPROVE® Filter
Millipore Express®

Características

hydrophilic

fabricante/nome comercial

Millipore Express®

Parâmetros

≤30 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
0.07 bar max. inlet pressure (1 psi) at 135 °C (Reverse)
0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward)
1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward)
1700 bar max. differential pressure (25 psi) at 80 °C (Forward)
2.07 bar max. inlet pressure (30 psi) at 25 °C (Reverse)
2100 mbar max. differential pressure (30 psi) at 25 °C (Reverse)
340 mbar max. differential pressure (5 psi) at 135 °C (Forward)
69 mbar max. differential pressure (1 psi) at 135 °C (Reverse)
6900 mbar max. differential pressure (100 psi) at 25 °C (Forward)
7 bar max. inlet pressure (100 psi) at 25 °C (Forward)

técnica(s)

sterile filtration: suitable

Comprimento

10 in.

Largura

2.7 in.

comprimento nominal do cartucho

10 in. (25 cm)

Diâmetro

6.9 cm (2.7 in.)

área de filtração

0.54 m2

Impurezas

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

matriz

Millipore Express® SHF

tamanho de poro

0.2 μm pore size

entrada

sample type liquid

ponto de bolha

≥4000 mbar (58 psig), air with water at 23 °C

código do cartucho

Code 7 (2-226; s w/locking-tabs)

Descrição geral

Device Configuration: Cartridge

Embalagem

Double Easy-Open bag

Outras notas

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.

Nota de preparo

Sterilization Method
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C; 25 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).

Nota de análise

Bacterial Retention
Samples 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

Informações legais

ASTM is a registered trademark of American Society for Testing and Materials
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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