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KPGES05TT1

Millipore

Capsule Opticap® XL, Millipore Express® PHF

sterile, Opticap® XL 5, inlet connection diam. 1.5 in., cartridge nominal length 5 in. (12.5 cm)

Sinonimo/i:

Opticap XL 5 Millipore Express PHF Sterile 0.2 μm 1-1/2 in. TC/TC

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About This Item

Codice UNSPSC:
23151806

Materiali

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

Livello qualitativo

Conformità normativa

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

Sterilità

irradiated
sterile

Nome Commerciale

Opticap® XL 5

Caratteristiche

hydrophilic

Produttore/marchio commerciale

Millipore Express®

Parametri

≤17.4 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
1000 bar max. differential pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. inlet pressure (80 psi) at 25 °C
5500 mbar max. differential pressure (80 psi) at 25 °C
80 psig max. inlet pressure

tecniche

bioburden reduction: suitable

Lunghezza

21.6 cm (8.5 in.)

Lunghezza nominale della cartuccia

5 in. (12.5 cm)

Diametro

10.7 cm (4.2 in.)

Superficie filtrante

0.31 m2

Diam. connessione ingresso

1.5 in.

Amp. ingresso/ uscita

21.6 cm (8.5 in.)

Diam. connessione uscita

1.5 in.

Impurezze

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

Matrice

Millipore Express® PHF

Dimensione pori

0.2 μm

Raccordi

1/4 in. drain/vent hose barb (with double O-ring seal)
inlet sanitary flange
outlet sanitary flange
(38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Descrizione generale

Device Configuration: Capsule
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

Confezionamento

Double Easy-Open bag

Altre note

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 sulla preparazione

Sterilization Method
3 autoclave cycles of 60 min @ 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).

Risultati analitici

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 6.0 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

Note legali

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

Esclusione di responsabilità

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

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