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KRK1A10HH1 Opticap® XL10 Polygard®-CR 0.1 µm 9/16 in. HB/HB

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KRK1A10HH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKRK1A10HH1
ReplacesKRK101HB1
Trade Name
  • Opticap®
DescriptionOpticap® XL10 Polygard®-CR 0.1 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®-CR
Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Physicochemical Information
Pore Size0.1 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Gravimetric ExtractablesThe extractables level was equal to or less than 55 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter9/16 in.
Nominal Pore Size0.1 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 ≥5 L
Global Trade Item Number
Catalogue Number GTIN
KRK1A10HH1 04053252262791

Documentation

Certificates of Quality

Title
Opticap XL 10 Capsule Polygard - CR Media C4HB43970
Opticap XL 10 Capsule Polygard -CR Media C7HA16350
Opticap XL 10 Capsule Polygard -CR Media C3PB74543
Opticap XL 10 Capsule Polygard -CR Media C7HA36251
Opticap XL 10 Capsule Polygard-CR Media C7DA81080
Opticap XL 10 Capsule Polygard-CR Media C9CA96696
Opticap XL 10 Capsule Polygard-CR Media - C7PA85858
Opticap XL 10 Capsule Polygard-CR Media - C8NA37942
Opticap XL 10 Capsule Polygard-CR Media C3DB96959
Opticap XL 10 Capsule Polygard-CR Media C7NA60877
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User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules