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KGW9A10TT1 Opticap® XL10 Polysep® II 2.0/1.2 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW9A10TT1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGW9A10TT1
ReplacesKGW901TC1
Trade Name
  • Opticap®
DescriptionOpticap® XL10 Polysep® II 2.0/1.2 µm 1-1/2 in. TC/TC
References
Product Information
FormatDouble 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
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 Size2.0 / 1.2 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 Diameter1-1/2 in.
Nominal Pore Size2.0 / 1.2 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 ≥5 L
Global Trade Item Number
Catalog Number GTIN
KGW9A10TT1 04053252258343

Documentation

Opticap® XL10 Polysep® II 2.0/1.2 µm 1-1/2 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 10 Capsule Polysep 11 Media C3NB71697
Opticap XL 10 Capsule Polysep II Media C0DB60676
Opticap XL 10 Capsule Polysep II Media C7CA83607
Opticap XL 10 Capsule Polysep II Media C7KA50848
Opticap XL 10 Capsule Polysep II Media C8CA31114
Opticap XL 10 Capsule Polysep II Media C0PB61832
Opticap XL 10 Capsule Polysep II Media C8CA53591
Opticap XL 10 Capsule Polysep II Media C9PA22175
Opticap XL 10 Capsule Polysep II Media - C7CA95790
Opticap XL 10 Capsule Polysep II Media - C7SA05033
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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