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KN3HA05FF1 Opticap® XL5 Polygard®-CN 30.0 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KN3HA05FF1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKN3HA05FF1
Trade Name
  • Opticap®
DescriptionOpticap® XL5 Polygard®-CN 30.0 µm 3/4 in. TC/TC
References
Product Information
FormatSingle Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)4.8 bar (70 psid) @ 20 °C
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °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.
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaPolygard®-CN
Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Physicochemical Information
Pore Size30.0 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 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
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 Length5 in. (12.5 cm)
Length21.6 cm (8.5 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.18 m²
Inlet to Outlet Width21.6 cm (8.5 in.)
Device Size5 in.
Inlet Connection Diameter3/4 in.
Nominal Pore Size30.0 µm
Outlet Connection Diameter3/4 in.
Materials Information
Chemistry
  • Polypropylene (PP)
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 ≥2 L
Global Trade Item Number
Katalogové číslo GTIN
KN3HA05FF1 04053252307744

Documentation

Certificates of Quality

Title
Opticap XL 5 Capsule Polygard - CN Media C7HA86657
Opticap XL 5 Capsule Polygard - CN Media C7KA44929
Opticap XL 5 Capsule Polygard - CN Media C8AA14749
Opticap XL 5 Capsule Polygard - CN Media - C9CA96690
Opticap XL 5 Capsule Polygard - CN Media C7SA08913
Opticap XL 5 Capsule Polygard -CN Media C2JB86321
Opticap XL 5 Capsule Polygard CN-Media C8AA15136
Opticap XL 5 Capsule Polygard-CN Media C7NA80227
Opticap XL 5 Capsule Polygard-CN Media C3NB63062
Opticap XL 5 Capsule Polygard-CN Media C3SB73735
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Data Sheet

Title
Polygard® CN Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules