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Millipore Express^® SHC 0.5/0.2µm, Opticap^® XLT 30 Capsule

Fittings 1-1/2 in. TC, Sterile

• Szinonimák: Opticap Sterile XLT 30 Millipore Express SHC 0.5/0.2 μm 1-1/2 in. TC
• UNSPSC kód: 23151806

Tulajdonságok

• Terméknév: Millipore Express^® SHC, Opticap^® XLT Capsule, Opticap^® XLT 30, sterile, inlet connection diam. 1.5 in., pore size 0.5/0.2 μm, cartridge nominal length 30 in. (75 cm)
• Anyagok: polyester support; polyethersulfone ; polypropylene ; polypropylene housing; polypropylene vent cap; polysulfone ; silicone seal
• Minőségi szint: 400
• szab. megfelelőség: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterilitás: irradiated; sterile
• termékcsalád: Opticap^® XLT 30
• Jellemzők: hydrophilic
• gyártó/kereskedő neve: Millipore Express^®
• Paraméterek: ≤93.7 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
• technika/technikák: sterile filtration: suitable
• Hosszúság: 87.1 cm (34.3 in.)
• patron névleges hossza: 30 in. (75 cm)
• Átmérő: 10.7 cm (4.2 in.)
• szűrőfelület: 1.63 m²
• bemeneti csatl. átmérője: 1.5 in.
• bemenettől kimenetig Sz: 15.2 cm (6.0 in.)
• kimeneti csatl. átmérője: 1.5 in.
• szennyeződések: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Mátrix: Millipore Express^® SHC
• pore size: 0.5/0.2 μm pore size
• buborékpont: ≥4000 mbar (58 psig), air with water at 23 °C
• szerelvény: 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)

Leírás

Általános leírás

Device Configuration: Capsule

T-line/Gauge Port: T-line

Kiszerelés

Double Easy-Open bag

Egyéb megjegyzések

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.

Elkészítési megjegyzés

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).

Analízis megjegyzés

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 63 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 ≥6 L

Jogi információk

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