CHVE72TS3

Millipore Express^® SHR with prefilter 0.5/0.1µm Cartridge 20

Code 7 Silicone, Autoclavable and SIP

• Synonim(y): Millipore Express SHR Cartridge Filter 20 in. 0.5/0.1 μm Code 7 Silicone, Millipore Express^® SHRP, Cartridge
• UNSPSC Code: 23151806
• eCl@ss: 32031690

Właściwości

• Nazwa produktu: Millipore Express^® SHR w/Prefilter Cartridge, Chemistry: 0.5 / 0.1 µm Hydrophilic Polyethersulfone (PES) Configuration: 20 in. Code 7
• Quality Segment: 400
• material: polyethersulfone , polypropylene , polypropylene support, polysulfone , silicone seal
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• sterility: non-sterile
• sterilization compatibility: autoclavable compatible; steam-in-place compatible
• product line: Millipore Express^®
• feature: hydrophilic
• manufacturer/tradename: Millipore Express^®
• parameter: ≤54.2 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C ( in water), 0.07 bar max. differential pressure (1 psi) at 135 °C (Reverse), 0.35 bar max. differential pressure (5 psi) at 135 °C (Forward), 1.0 psi max. differential pressure (69 mbar) at 135 °C (reverse), 1.7 bar max. differential pressure (25 psi) at 80 °C (Forward), 100 psi max. differential pressure (6.9 bar) at 25 °C (forward), 15 psi max. differential pressure (1.0 bar) at 135 °C (forward), 2.07 bar max. differential pressure (30 psi) at 25 °C (Reverse), 25 psi max. differential pressure (1.7 bar) at 80 °C (forward), 30 psi max. differential pressure (2.1 bar) at 25 °C (reverse), 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward)
• technique(s): sterile filtration: suitable
• L: 20 in.
• W: 2.7 in.
• cartridge nominal length: 20 in. (50 cm)
• diam.: 6.9 cm (2.7 in.)
• filtration area: 0.98 m² (10.6 ft²)
• impurities: ≤0.25 EU/mL (LAL test, Aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• matrix: Millipore Express^® SHR (w/Prefilter)
• pore size: 0.5/0.1 μm pore size
• bubble point: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• cartridge code: Code 7

Opis

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
25 forward or 22 forward and 3 reverse SIP cycles of 30 min @ 135 °C, or 3 forward cycles, 30 min., 135 °C at ≤ 1000 mbar (15 psid); 25 autoclave cycles of 60 min @ 126 °C

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).

Analysis Note

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 40 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 ≥4 L

Other Notes

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.

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

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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