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Millipore

Millipore Express® SHC High Area, Opticap® XLT Capsule

Opticap® XLT 10, non-sterile, pore size 0.5/0.2 μm, cartridge nominal length 10 in. (25 cm)

Sinonimo/i:

Gamma Compatible High Area Opticap® XLT 10 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC

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About This Item

Codice UNSPSC:
23151806

Materiali

polyester support
polyethersulfone
polypropylene
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

non-sterile

Compatibilità con la sterilizzazione

gamma compatible

Nome Commerciale

Opticap® XLT 10

Caratteristiche

hydrophilic

Produttore/marchio commerciale

Millipore Express®

Parametri

≤56.4 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
1.0 bar max. differential pressure (15 psi) at 80 °C (Forward)
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent)
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psi) at 25 °C (Forward)
6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent)
80 psig max. inlet pressure

tecniche

sterile filtration: suitable

Lunghezza

37.6 cm (14.8 in.)

Larghezza

4.2 in.

Lunghezza nominale della cartuccia

10 in. (25 cm)

Diametro

10.7 in. (4.2 cm)

Superficie filtrante

1.0 m2

Amp. ingresso/ uscita

15.2 cm (6.0 in.)

Diam. connessione uscita

1.5 in.

Impurezze

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

Matrice

Millipore Express® SHC High Area

pore size

0.5/0.2 μm pore size

Punto di bolla

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

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)

applicazioni

sample preparation

Descrizione generale

T-line/Gauge Port: T-line

Confezionamento

Double Easy-Open bag

Altre note

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Nota sulla preparazione

Sterilization Method
Gamma compatible to 45 kGy; 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 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 21 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 ≥2 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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