LCGL04TP6

Charged Durapore^® 0.22 µm, Optiseal^® Cartridge

OptiSeal^® 4 in., matrix Charged Durapore^®

• Sinonimo/i: Optiseal Charged Durapore Cartridge Filter 0.22 m
• Codice UNSPSC: 23151806
• eCl@ss: 32031690

Proprietà

• Materiali: PVDF ; polypropylene ; polypropylene support; silicone seal
• Livello qualitativo: 400
• Sterilità: non-sterile
• Compatibilità con la sterilizzazione: autoclavable compatible; steam-in-place compatible
• Nome Commerciale: OptiSeal^® 4 in.
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: OptiSeal^®
• Parametri: ≤4 mL/min air diffusion at 2.1 bar (30 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); 15 L/min flow rate at 850 mbar (ΔP); 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)
• tecniche: sterile filtration: suitable
• Lunghezza: 4 in.
• Lunghezza nominale della cartuccia: 4 in. (10 cm)
• Superficie filtrante: 0.2 m²
• Impurezze: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Estraibili (gravimetria): ≤10 mg/cartridge
• Matrice: Charged Durapore^®
• Dimensione pori: 0.22 μm
• input: sample type liquid
• Punto di bolla: ≥2760 mbar (40 psig), air with water at 23 °C
• Codice cartuccia: not applicable

Descrizione

Descrizione generale

Device Configuration: Cartridge

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 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.

Nota sulla preparazione

Sterilization Method
10 SIP cycles of 30 min @ 135 °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).

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.

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

Note legali

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