MCGB30S01

Cartouche Millidisk^® Durapore^® hydrophobe, 0,22 µm

Millidisk^® 30, filtration area 1500 cm², hydrophobic

• Synonyme(s) : Millidisk Cartridge 30-stack 0.22 μm hydrophobic
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PVDF ; polysulfone ; polysulfone support; silicone seal
• Niveau de qualité: 400
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible; steam-in-place compatible
• Gamme de produits: Millidisk^® 30
• Caractéristiques: hydrophobic
• Fabricant/nom de marque: Millidisk^®
• Paramètres: 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)
• Technique(s): gas filtration: suitable
• Surface de filtration: 1500 cm²
• Impuretés: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Extractibles par gravimétrie: ≤7.5 mg/device
• Matrice: Durapore^®
• Dimension de pores: 0.22 μm
• Entrée: sample type liquid
• Point de bulle: ≥1170 mbar (17.0 psig), nitrogen with 100% IPA at 23 °C
• Code de la cartouche: not applicable

Description

Description générale

Device Configuration: Cartridge

Stack Design: 30 Stak

Conditionnement

Easy-Open bag

Autres remarques

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.

Notes préparatoires

Sterilization Method
5 SIP cycles of 30 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).

Remarque sur l'analyse

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 a 70/30% IPA/water mixture at controlled room temperature

Informations légales

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