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KR75A51HH1 Opticap® XL1 Polygard®-CR 75 µm 9/16 in. HB/HB

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KR75A51HH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKR75A51HH1
Trade Name
  • Opticap®
DescriptionOpticap® XL1 Polygard®-CR 75 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 Size75.0 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Gravimetric ExtractablesThe extractables level was equal to or less than 10 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 Length1 in. (2.5 cm)
Length21.6 cm (8.5 in.)
Diameter10.7 cm (4.2 in.)
Inlet to Outlet Width21.6 cm (8.5 in.)
Device Size1 in.
Inlet Connection Diameter9/16 in.
Nominal Pore Size75.0 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 ≥1 L
Global Trade Item Number
Catalogue Number GTIN
KR75A51HH1 04053252392740

Documentation

Certificates of Quality

Title
Opticap XL 1 Capsule Polygard - CR Media - C0BB26465
Opticap XL 1 Capsule Polygard - CR Media - C9BA75004
Opticap XL 1 Capsule Polygard-CR Media C8DA59360
Opticap XL 1 Capsule Polygard-CR Media C8JA93923
Opticap XL 1 Capsule Polygard-CR Media C3DB02511
Opticap XL 1 Capsule Polygard-CR Media C7MA60884
Opticap XL 10 Capsule Polygard-CR Media C7NA71245
Opticap XL1 Capsule Polygard CR Media C0MB19992

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules