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KHGEG015FB3

Millipore

Capsule Opticap® XL, membrana Millipore Express® SHC

Opticap® XL 150, inlet connection diam. 3/4 in., pore size 0.5/0.2 μm, cartridge nominal length 3.8 in. (9.7 cm)

Sinonimo/i:

Opticap Gamma Compatible XL 150 Millipore Express SHC 0.5/0.2 m 3/4 in. TC-9/16 in. HB with Bell

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About This Item

Codice UNSPSC:
23151806

Materiali

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

Livello qualitativo

Conformità normativa

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

Descrizione

19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet with filling bell

Sterilità

non-sterile

Compatibilità con la sterilizzazione

gamma compatible

Nome Commerciale

Opticap® XL 150

Caratteristiche

hydrophilic

Produttore/marchio commerciale

Millipore Express®

Parametri

≤1.0 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C (in water)
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
100 psi max. differential pressure (6.9 bar) (intermittent)
2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

tecniche

sterile filtration: suitable

Lunghezza

9.7 cm (3.8 in.)

Larghezza

2.2 in.

Lunghezza nominale della cartuccia

3.8 in. (9.7 cm)

Diametro

5.6 cm (2.2 in.)

Superficie filtrante

140 cm2

Diam. connessione ingresso

3/4 in.

Amp. ingresso/ uscita

9.7 cm (3.8 in.)

Diam. connessione uscita

9/16 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® SHC

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 hose barb (with Bell)

Descrizione generale

Device Configuration: Capsule

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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

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 1.0 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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