KR05A10FF1

Opticap^® XL10 Polygard^® CR

inlet connection diam. 3/4 in., pore size 5.0 μm, cartridge nominal length 10 in. (25 cm)

• Synonyme(s) : Opticap XL10 Polygard CR 5.0 μm 3/4 in. TC/TC
• Code UNSPSC : 23151806

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.)
• Diam. du raccord d'entrée: 3/4 in.
• Largeur, de l'entrée à la sortie: 33.5 cm (13.2 in.)
• Diam. du raccord de sortie: 3/4 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^®-CR
• Dimension de pores: 5.0 μm nominal pore size; 5.0 μm pore size
• Entrée: sample type liquid
• Raccords: inlet sanitary flange; 19 mm (3/4 in.) inlet/outlet sanitary flange; outlet sanitary flange

Description

Description générale

Polygard^® CR products are nominally rated filters designed for particle removal applications in liquids and gases. The graded-density depth structure of Polygard^® CR filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.

The KR05A10FF1 Opticap^® XL10Polygard^® CR features a pore size of 5.0 μm. This single layer capsule filter has a sanitary flange inlet/outlet connection measuring 3/4 in. in diameter.

Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design with Polygard^® CR media minimizes hold-up volume and reduces production losses.

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.

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.