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KGW6A3TTT1 Opticap® XLT30 Polysep® II 1.0/0.5 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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KGW6A3TTT1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGW6A3TTT1
Trade Name
  • Opticap®
DescriptionOpticap® XLT30 Polysep® II 1.0/0.5 µm 1-1/2 in. TC
References
Product Information
FormatDouble Layer
HS Code8421 29 90
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 / 0.5 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 Area1.38 m²
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size30 in.
Inlet Connection Diameter1-1/2 in.
Nominal Pore Size1.0 / 0.5 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
KGW6A3TTT1 04053252300097

Documentation

Opticap® XLT30 Polysep® II 1.0/0.5 µm 1-1/2 in. TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Optcicap XLT 30 Capsule Polysep II Media C2PB30829
Opticap XLT 30 Capsule Polusep II Media C7PA86457
Opticap XLT 30 Capsule Polysep 11 Media C4KB68439
Opticap XLT 30 Capsule Polysep II Media C7CA77658
Opticap XLT 30 Capsule Polysep II Media C7NA68397
Opticap XLT 30 Capsule Polysep II Media C8AA08834
Opticap XLT 30 Capsule Polysep II Media C1EB01112
Opticap XLT 30 Capsule Polysep II Media C2AB04875
Opticap XLT 30 Capsule Polysep II Media C2EB76001
Opticap XLT 30 Capsule Polysep II Media C2HB84055
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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