LAGB04TP6

Optiseal^® Cartridge Media: Durapore^® 0.22 µm

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

• Synonym(e): Optiseal^® Durapore^® Cartridge Filter 0.22 µm hydrophobic, Durapore^® 0.22 µm, Optiseal^® Cartridge
• eCl@ss: 32031690
• UNSPSC Code: 23151806

Eigenschaften

• Produktname: Optiseal^® Cartridge Media: Durapore^® 0.22 µm, Chemistry: Hydrophobic Polyvinylidene Fluoride (PVDF) Configuration: 4 in.
• Quality Segment: 400
• material: PVDF , polypropylene , polypropylene support, silicone seal
• sterility: non-sterile
• sterilization compatibility: steam-in-place compatible
• product line: OptiSeal^® 4 in.
• feature: hydrophobic
• manufacturer/tradename: OptiSeal^®
• parameter: ≤2 mL/min nitrogen diffusion at 1.0 bar (15 psig) and 23 °C (in 60/40% IPA/water), 0.35 bar max. differential pressure (5 psid) at 121 °C (Forward), 0.35 bar max. inlet pressure (5 psi) at 135 °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): sterile filtration: 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^®
• pore size: 0.22 μm pore size
• input: sample type liquid
• bubble point: ≥1240 mbar (18 psig), nitrogen with 60/40% IPA/water at 23 °C
• cartridge code: not applicable

Beschreibung

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

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM^® F838 methodology.

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

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

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

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

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