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KN50A05HH1 Opticap® XL5 Polygard®-CN 5.0 µm 9/16 in. HB/HB

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KN50A05HH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKN50A05HH1
Trade Name
  • Opticap®
DescriptionOpticap® XL5 Polygard®-CN 5.0 µm 9/16 in. HB/HB
References
Product Information
FormatSingle Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
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 Size5.0 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
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 Diameter9/16 in.
Nominal Pore Size5.0 µm
Outlet Connection Diameter9/16 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
Catalogue Number GTIN
KN50A05HH1 04053252494659

Documentation

Certificates of Quality

Title
Opticap XL 5 Capsule Polygard - CN Media C7MA60840
Opticap XL 5 Capsule Polygard -CN Media C9PA13449
Opticap XL 5 Capsule Polygard -CN Media 85.00
Opticap XL 5 Capsule Polygard -CN Media C1SB07657
Opticap XL 5 Capsule Polygard -CN Media C8KA14027
Opticap XL 5 Capsule Polygard CN Media C0SB83060
Opticap XL 5 Capsule Polygard CN Media C0HB81670
Opticap XL 5 Capsule Polygard CN Media C0KB03998
Opticap XL 5 Capsule Polygard-CN Media C8DA59374
Opticap XL 5 Capsule Polygard-CN Media C8JA93996
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Data Sheet

Title
Polygard® CN Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules