KN06A10TT1

Opticap^® XL10 Polygard^® CN

inlet connection diam. 1.5 in., pore size 0.6 μm, cartridge nominal length 10 in. (25 cm)

• Synonyme(s) : Opticap XL10 Polygard CN 0.6 μm 1-1/2 in. TC/TC
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: 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)
• 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.; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• Longueur: 33.5 cm (13.2 in.)
• Longueur nominale des cartouches: 10 in. (25 cm)
• Diamètre: 10.7 cm (4.2 in.)
• Surface de filtration: 0.42 m²
• Diam. du raccord d'entrée: 1.5 in.
• Largeur, de l'entrée à la sortie: 33.5 cm (13.2 in.)
• Diam. du raccord de sortie: 1.5 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: ≤55 mg/capsule
• Matrice: Polygard^®-CN
• Dimension de pores: 0.6 μm nominal pore size; 0.6 μm pore size
• Entrée: sample type liquid
• Raccords: inlet sanitary flange; 38 mm (1 1/2 in.) inlet/outlet sanitary flange; outlet sanitary flange

Description

Description générale

Device Configuration: Capsule

Caractéristiques et avantages

Format: Single 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 reduction
• 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.

Liaison

Replaces: KN0601TC1

Notes préparatoires

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

Remarque sur l'analyse

Gravimetric Extractables: after 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

POLYGARD 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.