MPGL10CB

Gamma-kompatible Millipak^®-100

pore size 0.22 μm, filtration area 500 cm², matrix Durapore^®

• Synonym(e): Gamma Compatible Millipak^®-100 Filter Unit 0.22 µm 1/4 in. NPTM
• UNSPSC-Code: 23151806

Eigenschaften

• Materialien: PVDF
• Qualitätsniveau: 400
• Sterilität: sterile
• Produktlinie: EMPROVE^® Filter
• Leistungsmerkmale: hydrophilic
• Hersteller/Markenname: Millipak^®
• Filtrationsfläche: 500 cm²
• Durchm. Einlassanschluss: 1/4 in.
• Durchm. Auslassanschluss: 1/4 in.
• Verunreinigungen: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Gravimetrisch bestimmte extrahierbare Substanzen: ≤2.5 mg/device
• Matrix: Durapore^®
• Porengröße: 0.22 μm pore size
• Fitting: NPT inlet connection; NPT outlet connection

Beschreibung

Allgemeine Beschreibung

Device Configuration: Filtereinheit

Number of stacked discs: 100 discs

Sonstige Hinweise

Diese Produkte werden in einem Werk hergestellt, das den GMP-Richtlinien der FDA entspricht.

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.

Angaben zur Herstellung

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).

Hinweis zur Analyse

Bacterial Retention
Quantitative Rückhaltung von Brevundimonas diminuta bei einer Mindestbeaufschlagung von 1 x 10⁷ KBE/cm² unter Anwendung der ASTM^® F838-Methode.

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Rechtliche Hinweise

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

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

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

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