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KGW3A10FF1 Opticap® XL10 Polysep® II 1.0/0.2 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW3A10FF1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGW3A10FF1
Trade Name
  • Opticap®
DescriptionOpticap® XL10 Polysep® II 1.0/0.2 µm 3/4 in. TC/TC
References
Product Information
FormatDouble Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 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
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.
Prefilter MaterialBorosilicate Glass Fiber (BGF)
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 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Gravimetric ExtractablesThe extractables level was equal to or less than 145 mg per capsule after a 5 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.46 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter3/4 in.
Nominal Pore Size1.0 / 0.2 µm
Outlet Connection Diameter3/4 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 ≥5 L
Global Trade Item Number
Catalogue Number GTIN
KGW3A10FF1 04053252355455

Documentation

Opticap® XL10 Polysep® II 1.0/0.2 µm 3/4 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 10 Capsule Polysep II Media C0AB93479
Opticap XL 10 Capsule Polysep II Media C3JB30881
Opticap XL 10 Capsule Polysep II Media C7JA37079
Opticap XL 10 Capsule Polysep II Media C1JB39369
Opticap XL 10 Capsule Polysep II Media C1MB58124
Opticap XL 10 Capsule Polysep II Media C3EB05289
Opticap XL 10 Capsule Polysep II Media C3KB44269
Opticap XL 10 Capsule Polysep II Media C7HA25713
Opticap XL 10 Capsule Polysep II Media C7MA60891
Opticap XL 10 Capsule Polysep II Media C8AA15044
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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