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KGW6A02HH3 Opticap® XL2 Polysep® II 1.0/0.5 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KGW6A02HH3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGW6A02HH3
ReplacesSN1M017A01
Trade Name
  • Opticap®
DescriptionOpticap® XL2 Polysep® II 1.0/0.5 µm 9/16 in. HB/HB
References
Product Information
FormatDouble Layer
HS Code8421 22 00
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
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 ConnectionHose Barb
Outlet ConnectionHose Barb
Gravimetric ExtractablesThe extractables level was equal to or less than 45 mg per capsule after a 600 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 Length2 in. (5 cm)
Length14.2 cm (5.6 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.06 m²
Inlet to Outlet Width14.2 cm (5.6 in.)
Device Size2 in.
Inlet Connection Diameter9/16 in.
Nominal Pore Size1.0 / 0.5 µm
Outlet Connection Diameter9/16 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 ≥1 L
Global Trade Item Number
Catalog Number GTIN
KGW6A02HH3 04053252256394

Documentation

Opticap® XL2 Polysep® II 1.0/0.5 µm 9/16 in. HB/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
OPTICAP XL 2 Capsule Polysep media C3EB89580
OPTICAP XL 2 Capsule Polysep II Media C3KB53569
OPTICAP XL 2 Capsule Polysep II media C3MB62337
Opticap XL 2 Capsule Polysep II Media C9EA29189
Opticap XL 2 Capsule Polysep 11 Media C1SB07656
Opticap XL 2 Capsule Polysep II Media C7CA91135
Opticap XL 2 Capsule Polysep II Media C7NA70182
Opticap XL 2 Capsule Polysep II Media C7MA60886
Opticap XL 2 Capsule Polysep II Media C7SA08936
Opticap XL 2 Capsule Polysep II Media C1AB83102
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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