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KVGLA2ZTT1 Opticap® XLT 20 with Durapore® - 20" 0.22 µm TC/TC, w/ gauge port 1pk

KVGLA2ZTT1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKVGLA2ZTT1
Trade Name
  • Opticap®
DescriptionOpticap® XLT 20 with Durapore® - 20" 0.22 µm TC/TC, w/ gauge port 1pk
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal; 3/4 in. Gauge Port
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.4 bar (50 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
European Pressure Equipment DirectiveEMD 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.
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
T-line/Gauge PortT-line with 3/4 in. Gauge Port T-line side
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilityOther
Sterilization3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤26.6 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 50 mg per capsule after 24 hours in water at controlled room temperature.
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Inlet Pressure (psig)80 psig
Maximum Inlet Temperature25 °C
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length20 in. (50 cm)
Length62.5 cm (24.6 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area1.4 m²
Inlet to Outlet Width19.8 cm (7.8 in.)
Device Size20 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolypropylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
Global Trade Item Number
Référence GTIN
KVGLA2ZTT1 04053252484995

Documentation

Material Qualification Dossier

TitreVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificats de qualité

Titre
Opticap XLT 20 Capsule Durapore Membrane C0JB89018Z
Opticap XLT 20 Capsule Durapore Membrane - C8AA22636
Opticap XLT 20 Capsule Durapore Membrane - C8BA31305
Opticap XLT 20 Capsule Durapore Membrane - C8DA37956
Opticap XLT 20 Capsule Durapore Membrane - C9HA51657
Opticap XLT 20 Capsule Durapore Membrane C1MB42460
Opticap XLT 20 Capsule Durapore Membrane C2EB67715
Opticap XLT 20 Capsule Durapore Membrane C3DB09178
Opticap XLT 20 Capsule Durapore Membrane C3MB52163
Opticap XLT 20 Capsule Durapore Membrane C3SB68067

Fiche technique

Titre
Durapore® Family Guide

Manuels d'utilisation

Titre
Opticap® XL Capsules and Opticap® XLT Capsules