KTGRA04HH3

Aervent^® 0,2 µm, capsule Opticap^® XL

inlet connection diam. 9/16 in., Opticap^® XL 4, pore size 0.2 μm, cartridge nominal length 7.6 in. (19.3 cm)

• Synonyme(s) : Opticap Sterilizing Grade XL4 Aervent 0.2 µm 9/16 in. HB/HB
• Code UNSPSC : 23151806
• eCl@ss : 32031690

Propriétés

• Matériaux: PTFE ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Niveau de qualité: 400
• Stérilité: non-sterile
• Mode de stérilisation compatible: autoclavable compatible
• Gamme de produits: Opticap^® XL 4
• Caractéristiques: hydrophobic
• Fabricant/nom de marque: Opticap^®
• Paramètres: ≤9 mL/min nitrogen diffusion at 965 mbar (14 psig) and 23 °C (in 70/30% IPA/water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.8 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 4.1 bar max. differential pressure (60 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): gas filtration: suitable
• Longueur: 7.7 in.
• Largeur: 3.3 in.
• Longueur nominale des cartouches: 7.6 in. (19.3 cm)
• Diamètre: 8.4 cm (3.3 in.)
• Surface de filtration: 0.21 m²
• Diam. du raccord d'entrée: 9/16 in.
• Largeur, de l'entrée à la sortie: 19.3 cm (7.6 in.)
• Diam. du raccord de sortie: 9/16 in.
• Impuretés: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• Extractibles par gravimétrie: ≤15 mg
• Matrice: Aervent^®
• Dimension de pores: 0.2 μm pore size
• Point de bulle: ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• Raccords: 1/4 in. drain/vent hose barb (with double O-ring Seal); inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

Description

Description générale

Device Configuration: Capsule

Conditionnement

Double Easy-Open bag

Liaison

Replaces: KTGP04HB3

Notes préparatoires

Sterilization Method
30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable

This product was manufactured with a PTFE 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 a 70/30% IPA/water mixture at controlled room temperature

HydroCorr: ≤0.25 mL/min @ 2.6 bar (38 psig)

Autres remarques

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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Informations légales

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

ASTM is a registered trademark of American Society for Testing and Materials

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.