KVGLS10TH1

Durapore^® 0,22 µm, capsule Opticap^® XL

sterile, Opticap^® XL 10, inlet connection diam. 1.5 in.

• Synonyme(s) : Opticap Sterile XL10 Durapore 0.22 μm TC/HB
• Code UNSPSC : 23151806

Propriétés

• Matériaux: PVDF ; polyester support; polyethylene support; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap; silicone outer O-ring; silicone-coated EPDM rubber lead O-ring
• Niveau de qualité: 400
• Conformité réglementaire: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• Stérilité: irradiated; sterile
• Gamme de produits: Opticap^® XL 10
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Opticap^®
• Paramètres: ≤14 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• Technique(s): sterile filtration: suitable
• Longueur: 33.3 cm (13.1 in.)
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diamètre: 10.7 cm (4.2 in.)
• Surface de filtration: 0.73 m²
• Diam. du raccord d'entrée: 1.5 in.
• Largeur, de l'entrée à la sortie: 33.3 cm (13.1 in.)
• Diam. du raccord de sortie: 9/16 in.
• 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: ≤25 mg/capsule
• Matrice: Durapore^®
• Dimension de pores: 0.22 μm
• Entrée: sample type liquid
• Point de bulle: ≥3450 mbar (50 psig), air with water at 23 °C
• Raccords: 1/4 in. drain/vent hose barb (with double O-ring Seal); (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Description

Description générale

Device Configuration: Capsule

Conditionnement

Double 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
3 autoclave cycles of 60 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).

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: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

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.