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KN50A05FF1 Opticap® XL5 Polygard®-CN 5.0 µm 3/4 in. TC/TC

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KN50A05FF1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKN50A05FF1
Trade Name
  • Opticap®
DescriptionOpticap® XL5 Polygard®-CN 5.0 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 Size5.0 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 Size5.0 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
Catalogue Number GTIN
KN50A05FF1 04053252352171

Documentation

Certificates of Quality

Title
Opticap XL 5 Capsule Polygard -CN Media C8JA94105
Opticap XL 5 Capsule Polygard -CN Media C8DA46096
Opticap XL 5 Capsule Polygard-CN Media - C0CB37998
Opticap XL 5 Capsule Polygard-CN Media - C7HA24953
Opticap XL 5 Capsule Polygard-CN Media - C9MA92178
Opticap XL 5 Capsule Polygard-CN Media C2JB89063
Opticap XL 5 Capsule Polygard-CN Media C3PB79235
Opticap XL 5 Capsule Polygard-CN Media C4CB17625
Opticap XL 5 Capsule Polygard-CN Media C8CA35990

Data Sheet

Title
Polygard® CN Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules