KN12A3TTT1

Opticap^® XLT30 Polygard^®

inlet connection diam. 1.5 in., pore size 1.2 μm, cartridge nominal length 30 in. (75 cm)

• Synonyme(s) : Opticap XLT 30" Polygard CN 1.2 um 1.5" TC/TC 1/pk
• 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: 25 °C max. inlet temp.; 80 psig max. inlet pressure
• Longueur nominale des cartouches: 30 in. (75 cm)
• Diam. du raccord d'entrée: 1.5 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: ≤165 mg/capsule
• Matrice: Polygard^®-CN
• Dimension de pores: 1.2 μm nominal pore size; 1.2 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

T-line/Gauge Port: T-line

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.

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

Informations légales

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

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