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KGW6A04FF3 Opticap® XL4 Polysep® II 1.0/0.5 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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KGW6A04FF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGW6A04FF3
Trade Name
  • Opticap®
DescriptionOpticap® XL4 Polysep® II 1.0/0.5 µm 3/4 in. TC/TC
References
Product Information
FormatDouble Layer
HS Code8421 22 00
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 / 0.5 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Gravimetric ExtractablesThe extractables level was equal to or less than 85 mg per capsule after a 1200 mL 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 Length4 in. (10 cm)
Length19.6 cm (7.7 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.11 m²
Inlet to Outlet Width19.6 cm (7.7 in.)
Device Size4 in.
Inlet Connection Diameter3/4 in.
Nominal Pore Size1.0 / 0.5 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 Size3
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
Catalog Number GTIN
KGW6A04FF3 04053252487378

Documentation

Opticap® XL4 Polysep® II 1.0/0.5 µm 3/4 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 4 Capsule Polysep II Media
Opticap XL 4 Capsule Polysep II Media C1CB16676
Opticap XL 4 Capsule Polysep II Media C9HA35341
Opticap XL 4 Capsule Polysep II Media - C7NA79742
Opticap XL 4 Capsule Polysep II Media C3EB14958
Opticap XL 4 Capsule Polysep II Media C3JB27491
Opticap XL 4 Capsule Polysep II Media C3MB44270
Opticap XL 4 Capsule Polysep II Media C8SA65233
Opticap XL 4 Capsule Polysep II Media C9JA61672
Opticap XL 4 Capsule Polysep II Media- C3CB79083

Technical Info

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

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules