KVGBA04TH3

Membrane Durapore^® hydrophobe de 0,22 µm, Capsule Opticap^® XL

Opticap^® XL 4, pore size 0.22 μm

• Synonyme(s) : Durapore^® Capsule Filter 4 in. 0.22 µm
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PVDF
• 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: Opticap^® XL 4
• Caractéristiques: hydrophobic
• Fabricant/nom de marque: Durapore^®
• Paramètres: 25 °C max. inlet temp.; 80 psig max. inlet pressure
• Technique(s): sterile filtration: suitable
• Diam. du raccord d'entrée: 1.5 in.
• Diam. du raccord de sortie: 9/16 in.
• Taille: 4 in.
• Impuretés: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Matrice: Durapore^®
• Dimension de pores: 0.22 μm pore size
• Raccords: (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb 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 section of OPTICAP^® XL Capsules and OPTICAP^® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Notes préparatoires

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.

Informations légales

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

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

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

Clause de non-responsabilité

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.