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KGW1A3TTT1 Opticap® XLT30 Polysep® II 1.0/0.2/0.1 µm 1-1/2 in. TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW1A3TTT1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGW1A3TTT1
Trade Name
  • Opticap®
DescriptionOpticap® XLT30 Polysep® II 1.0/0.2/0.1 µm 1-1/2 in. TC
References
Product Information
FormatTriple Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
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 / 0.2 / 0.1 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
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 Area1.26 m²
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size30 in.
Inlet Connection Diameter1-1/2 in.
Nominal Pore Size1.0 / 0.2 / 0.1 µm
Outlet Connection Diameter1-1/2 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
KGW1A3TTT1 04053252609329

Documentation

Opticap® XLT30 Polysep® II 1.0/0.2/0.1 µm 1-1/2 in. TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap CLT 30 Capsule Polysep II Media C1JB21354
Opticap XLT 30 Capsule Polysep II Meddia C8NA15517
Opticap XLT 30 Capsule Polysep II Media C0KB00068
Opticap XLT 30 Capsule Polysep II Media C7EA01783
Opticap XLT 30 Capsule Polysep II Media C7EA99885
Opticap XLT 30 Capsule Polysep II Media C7JA20801
Opticap XLT 30 Capsule Polysep II Media C7PA86456
Opticap XLT 30 Capsule Polysep II Media C8NA15518
Opticap XLT 30 Capsule Polysep II Media C0DB47773
Opticap XLT 30 Capsule Polysep II Media C0DB47775
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Safe Handling and Storage of Filtration Devices Containing Mixed Cellulose Ester Membranes

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules
Visual Inspection Guide