KGW9A10HH1

Capsule Opticap^® XL, Polysep^™ II 2,0/1,2 µm de dimension de pores nominale

inlet connection diam. 9/16 in., Opticap^® XL 10, pore size 2.0/1.2 μm, cartridge nominal length 10 in. (25 cm)

• Synonyme(s) : Opticap XL10 Polysep II 2.0/1.2 μm 9/16 in. HB/HB
• Code UNSPSC : 23151806
• eCl@ss : 32031610

Propriétés

• Matériaux: borosilicate glass fiber (BGF) prefilter; mixed cellulose esters (MCE) ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• 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 10
• Caractéristiques: hydrophilic
• Fabricant/nom de marque: Opticap^®
• Paramètres: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 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; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• Technique(s): prefiltration: suitable
• Longueur: 33.5 cm (13.2 in.)
• Largeur: 4.2 in.
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diamètre: 14.5 cm (5.7 in.)
• Surface de filtration: 0.46 m²
• Diam. du raccord d'entrée: 9/16 in.
• Largeur, de l'entrée à la sortie: 33.5 cm (13.2 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: ≤145 mg/capsule
• Matrice: Polysep^™ II
• pore size: 2.0/1.2 μm nominal pore size; 2.0/1.2 μm pore size
• Entrée: sample type liquid
• Raccords: inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

Description

Description générale

Device Configuration: Capsule

Caractéristiques et avantages

Format: Double Layer

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
• Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Liaison

Replaces: KGW901HB1

Notes préparatoires

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

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

Remarque sur l'analyse

Gravimetric Extractables: after a 5 L flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

Informations légales

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

Polysep is a trademark of Sigma-Aldrich Co. LLC

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.

Informations sur la sécurité

• Code de la classe de stockage: 11 - Combustible Solids
• Classe de danger pour l'eau (WGK): WGK 2