LAHL04PP6

Optiseal^® Cartridge Media: Durapore^® 0.45 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 4 in.

• Synonim(y): Optiseal Durapore Cartridge Filter 0.45 μm, Optiseal^® Cartridge Filter Durapore^®
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Właściwości

• Nazwa produktu: Optiseal^® Cartridge Media: Durapore^® 0.45 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 4 in.
• Quality Segment: 400
• material: PVDF , polypropylene , polypropylene support, 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: OptiSeal^®
• feature: hydrophilic
• manufacturer/tradename: OptiSeal^®
• parameter: ≤4 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water), 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 121 °C (Forward), 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse), 3.5 bar max. differential pressure (50 psid) at 80 °C (Forward), 3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse), 3.5 bar max. inlet pressure (50 psi) at 80 °C (Forward), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• technique(s): bioburden reduction: suitable
• L: 4 in.
• cartridge nominal length: 4 in. (10 cm)
• filtration area: 0.18 m²
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤10 mg/cartridge
• matrix: Durapore^®
• input: sample type liquid
• bubble point: ≥1930 mbar (28 psig), air with water at 23 °C
• cartridge code: not applicable

Opis

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
30 SIP cycles of 30 min @ 135 °C; 10 autoclave cycles of 30 min @ 126 °C

This product was manufactured with a Durapore^® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

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 for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• 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

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany

OPTISEAL is a registered trademark of Merck KGaA, Darmstadt, Germany

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