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Millipore Express^® SHF, Opticap^® XLT Capsule

Opticap^® XLT 10, sterile, inlet connection diam. 1.5 in., cartridge nominal length 10 in. (25 cm)

• Sinonimo/i: Opticap XLT 10 Millipore Express SHF Sterile 0.2 μm 1-1/2 in. TC
• Codice UNSPSC: 23151806

Proprietà

• Materiali: polyester support; polyethersulfone ; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Livello qualitativo: 400
• Conformità normativa: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Sterilità: irradiated; sterile
• Nome Commerciale: Opticap^® XLT 10
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: Millipore Express^®
• Parametri: ≤32.7 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 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• tecniche: sterile filtration: suitable
• Lunghezza: 37.6 cm (14.8 in.)
• Lunghezza nominale della cartuccia: 10 in. (25 cm)
• Diametro: 10.7 cm (4.2 in.)
• Superficie filtrante: 0.57 m²
• Diam. connessione ingresso: 1.5 in.
• 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); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Millipore Express^® SHF
• Dimensione pori: 0.2 μm
• 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)

Descrizione

Descrizione generale

Device Configuration: Capsule

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

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.

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
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 11 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 ≥1.5 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.