MPGL06CL1

Capsula Millipak^® con filtro Durapore^® da 0,22 µm

sterile, filtration area 300 cm², matrix Durapore^®

• Sinonimo/i: Millipak-60 Filling Machine Filter Unit 0.22 μm 1-1/2 in. TC-1/4 in.HB
• Codice UNSPSC: 23151806
• eCl@ss: 32031690
• NACRES: NB.24

Proprietà

• Materiali: PVDF membrane; PVDF vent cap; polycarbonate ; polycarbonate support
• Livello qualitativo: 400
• Sterilità: irradiated; sterile
• Nome Commerciale: Millipak^®
• Caratteristiche: hydrophilic
• Produttore/marchio commerciale: Millipak^®
• Parametri: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 5.2 bar max. inlet pressure (75 psi) at 25 °C; 7.6 L/min flow rate at 2.9 bar (ΔP)
• tecniche: sterile filtration: suitable
• Superficie filtrante: 300 cm²
• Diam. connessione ingresso: 1-1/2 in.
• Diam. connessione uscita: 1/4 in.
• Impurezze: ≤0.5 EU/mL (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Estraibili (gravimetria): ≤2 mg/device
• Matrice: Durapore^®
• Dimensione pori: 0.22 μm
• Punto di bolla: ≥3450 mbar (50 psig), air with water at 23 °C
• Raccordi: inlet sanitary flange; outlet hose barb; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)
• Condizioni di spedizione: ambient

Descrizione

Descrizione generale

Device Configuration: Capsule

Number of stacked discs: 60 discs

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
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable

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 ≥200 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

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