MCGL40S03

Durapore^® 0.22 µm, Millidisk^® Cartridge

filtration area 2000 cm², hydrophilic

• Szinonimák: Millidisk Cartridge 40-stack 0.22 μm Hydrophilic
• UNSPSC kód: 23151806
• eCl@ss: 32031690

Tulajdonságok

• Anyagok: PVDF ; polysulfone ; polysulfone support; silicone seal
• Minőségi szint: 400
• sterilitás: non-sterile
• Sterilizálási kompatibilitás: autoclavable compatible; steam-in-place compatible
• termékcsalád: Millidisk^®
• Jellemzők: hydrophilic
• gyártó/kereskedő neve: Millidisk^®
• Paraméterek: 0.35 bar max. differential pressure (5 psid) at 123 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 123 °C (Forward); 0.7 bar max. differential pressure (10 psid) at 25 °C (Reverse); 0.7 bar max. inlet pressure (10 psi) at 25 °C (Reverse); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) at 25 °C (Forward); 4.1 bar max. inlet pressure (60 psi) at 25 °C (Forward); 53 L/min flow rate at 2.8 bar (ΔP)
• technika/technikák: sterile filtration: suitable
• szűrőfelület: 2000 cm²
• szennyeződések: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetriás extrahálható anyagok: ≤10 mg/device
• Mátrix: Durapore^®
• pórusméret: 0.22 μm
• bemenet: sample type liquid
• buborékpont: ≥3450 mbar (50 psig), air with water at 23 °C
• patronkód: not applicable

Leírás

Általános leírás

Device Configuration: Cartridge

Stack Design: 40 Stak

Kiszerelés

Double Easy-Open bag

Egyéb megjegyzések

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.

Elkészítési megjegyzés

Sterilization Method
5 SIP cycles of 60 min @ 135 °C; 5 autoclave cycles of 60 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).

Analízis megjegyzés

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: using sterilized device after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL

Jogi információk

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

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

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