SGEPA25NB6

Capsule OptiScale^®, Millipore Express^® SHF

OptiScale^® 25, filtration area 3.5 cm²

• Synonyme(s) : Millipore Express SHF Optiscale 25mm 0.2 μm NB
• Code UNSPSC : 23151806
• eCl@ss : 32031690
• Nomenclature NACRES : NB.24

Propriétés

• Matériaux: polyethersulfone membrane; polypropylene ; polypropylene support; polypropylene vent cap
• Niveau de qualité: 400
• Conformité réglementaire: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible
• Gamme de produits: OptiScale^® 25
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Millipore Express^®
• Paramètres: 4.1 bar max. inlet pressure (60 psi) at 25 °C; 60 psi max. differential pressure (4.1 bar) at 25 °C (forward)
• Technique(s): sterile filtration: suitable
• Longueur: 3.9 cm (1.52 in.)
• Longueur nominale des cartouches: 1.52 in. (39 mm)
• Diamètre: 3.1 cm (1.2 in.)
• Surface de filtration: 3.5 cm²
• Impuretés: ≤0.25 EU/mL (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Millipore Express^® SHF
• Dimension de pores: 0.2 μm
• Raccords: female Luer-Lok^® inlet connection; male Luer-Lok^® outlet connection; (Female Luer-Lok^® Inlet/Male Luer Slip Outlet)

Description

Description générale

Device Configuration: Capsule

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 installation and wetting sections of OPTISCALE^®-25 user guide
• Storage Statement: Please refer to OPTISCALE^®-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Notes préparatoires

Sterilization Method
1 autoclave cycle of 60 min @ 123 °C

This product was manufactured with a Millipore Express membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Remarque sur l'analyse

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64>.

This product was tested and passes the USP <78> test for particulates in injectables.

Informations légales

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany

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