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Merck

K002A05HH1

Opticap® XL Capsule Filter

pore size 0.2 μm, cartridge nominal length 5 in. (12.5 cm), filter diam. 4.2 in. (10.7 cm)

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Code UNSPSC :
23151806

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Matériaux

polypropylene filter
polypropylene housing
polypropylene support
silicone seal

Niveau de qualité

Conformité réglementaire

meets FDA 21 CFR 177-182 (all component materials)

Fabricant/nom de marque

Opticap®

Paramètres

max. inlet temp. at 25 °C
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

Longueur nominale des cartouches

5 in. (12.5 cm)

Taille du dispositif

5 in.

Longueur du filtre

8.5 in. (21.6 cm)

Diam. du filtre

4.2 in. (10.7 cm)

Diam. du raccord d'entrée

9/16 in. , hose barb

Largeur de l'entrée à la sortie

21.6 cm (8.5 in.)

Impuretés

≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)

Matrice

Clarigard®

Dimension de pores

0.2 μm pore size

Raccords

inlet/outlet connection for 14 mm (9/16 in.) hose barb

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Cet article
K003A05TT1KHGES2TTH1KHGES1TTH1
fitting

inlet/outlet connection for 14 mm (9/16 in.) hose barb

fitting

inlet/outlet connection for 38 mm (1 1/2 in.) sanitary flange

fitting

(38 mm (1 ½ in.) Sanitary Flange Inlet and 16 mm (5?8 in.) Hose Barb Outlet)

fitting

(38 mm (1 ½ in.) Sanitary Flange Inlet and 16 mm (5?8 in.) Hose Barb Outlet)

material

polypropylene filter, polypropylene support, polypropylene housing, silicone seal

material

polypropylene filter, polypropylene housing, polypropylene support, silicone seal

material

polyester support, polypropylene device, polypropylene housing, polypropylene vent cap, polysulfone device, silicone seal

material

polyester support, polypropylene device, polypropylene housing, polypropylene vent cap, polysulfone device, silicone seal

impurities

≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)

impurities

≤0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction)

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (sample aqueous extraction)

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction), <0.25 EU/mL USP bacterial endotoxins (sample aqueous extraction)

parameter

max. inlet temp. at 25 °C, 2.75 bar max. inlet pressure (40 psi) at 60 °C, 5.5 bar max. inlet pressure (80 psi) at 23 °C, 1.0 bar max. inlet pressure (15 psi) at 80 °C, 80 psig max. inlet pressure

parameter

max. inlet temp. at 25 °C, 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.75 bar max. inlet pressure (40 psi) at 60 °C, 4.8 bar max. differential pressure (70 psid) at 20 °C, 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure

parameter

≤62.5 mL/min air diffusion at 2.8 bar (40 psig) (in water), 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 100 psi max. differential pressure (6.9 bar) (intermittent), 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C, 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent), 80 psi max. differential pressure (5.5 bar) (continuous), 80 psig max. inlet pressure

parameter

≤31.2 mL/min air diffusion at 2.8 bar (40 psig) (in water), 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 1.0 bar max. inlet pressure (15 psi) at 80 °C, 100 psi max. differential pressure (6.9 bar) (intermittent), 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C, 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent), 80 psi max. differential pressure (5.5 bar) (continuous), 80 psig max. inlet pressure

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

manufacturer/tradename

Opticap®

manufacturer/tradename

Opticap®

manufacturer/tradename

Millipore Express®

manufacturer/tradename

Millipore Express®

Description générale

Cartridge Type: Liquid
Device Configuration: Capsule

Conditionnement

Double Easy-Open bag

Notes préparatoires

Sterilization Method:
3 autoclave cycles of 30min at 126°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 21CFR210.3(b)(6).

Remarque sur l'analyse

Gravimetric Extractables: ≤ 55mg per capsule after 24 hours in water at controlled room temperature.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2L

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 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

Informations légales

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

Code de la classe de stockage

10-13 - German Storage Class 10 to 13


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