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KR50A10HH1 Opticap® XL10 Polygard®-CR 50 µm 9/16 in. HB/HB

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KR50A10HH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKR50A10HH1
ReplacesKR5001HB1
Trade Name
  • Opticap®
DescriptionOpticap® XL10 Polygard®-CR 50 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 Size50.0 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 Size50.0 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 ≥5 L
Global Trade Item Number
Catalogue Number GTIN
KR50A10HH1 04053252449185

Documentation

Certificates of Quality

Title
Opticap XL 10 Capsule Polygard -CR Media C7HA24952
Opticap XL 10 Capsule Polygard -CR Media C9HA29199
Opticap XL 10 Capsule Polygard -CR Media C8BA35997
Opticap XL 10 Capsule Polygard -CR Media C8JA94024
Opticap XL 10 Capsule Polygard -CR Media C8NA37932
Opticap XL 10 Capsule Polygard CR Media C0PB61969
Opticap XL 10 Capsule Polygard CR Media C2PB42006
Opticap XL 10 Capsule Polygard-CR Media - C7MA60848
Opticap XL 10 Capsule Polygard-CR Media - C8KA13453
Opticap XL 10 Capsule Polygard-CR Media C1HB15204
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User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules