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KGW6A3THH1 Opticap® XLT30 Polysep® II 1.0/0.5 µm 5/8 in. HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW6A3THH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGW6A3THH1
Trade Name
  • Opticap®
DescriptionOpticap® XLT30 Polysep® II 1.0/0.5 µm 5/8 in. HB
References
Product Information
FormatDouble Layer
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Prefilter MaterialBorosilicate Glass Fiber (BGF)
T-line/Gauge PortT-line
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaPolysep™ II
Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
Physicochemical Information
Pore Size1.0 / 0.5 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Gravimetric ExtractablesThe extractables level was equal to or less than 435 mg per capsule after a 15 L flush and 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 media combination 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 Length30 in. (75 cm)
Length87.1 cm (34.3 in.)
Filtration Area1.38 m²
Inlet to Outlet Width19.8 cm (7.8 in.)
Device Size30 in.
Inlet Connection Diameter5/8 in.
Nominal Pore Size1.0 / 0.5 µm
Outlet Connection Diameter5/8 in.
Materials Information
Chemistry
  • Mixed Cellulose Esters (MCE)
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 ≥15 L
Global Trade Item Number
Catalogue Number GTIN
KGW6A3THH1 04053252258497

Documentation

Opticap® XLT30 Polysep® II 1.0/0.5 µm 5/8 in. HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XLT 30 Capsule Polysep II Media C7MA66961
Opticap XLT 30 Capsule Polysep II Media C8AA11259
Opticap XLT 30 Capsule Polysep II Media C8BA31395
Opticap XLT 30 Capsule Polysep II Media C8DA38615
Opticap XLT 30 Capsule Polysep II Media C1BB93153
Opticap XLT 30 Capsule Polysep II Media C3JB46099
Opticap XLT 30 Capsule Polysep II Media C7MA66958
Opticap XLT 30 Capsule Polysep II Media C7NA68168
Opticap XLT 30 Capsule Polysep II Media C8KA93974
Opticap XLT 30 Capsule Polysep II Media C8MA25741
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules