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KR99A51TT1 Opticap® XL1 Polygard®-CR 100 µm 1-1/2 in. TC/TC

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KR99A51TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKR99A51TT1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL1 Polygard®-CR 100 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatSingle Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 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®-CR
      Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size100.0 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      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 Diameter1-1/2 in.
      Nominal Pore Size100.0 µm
      Outlet Connection Diameter1-1/2 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
      KR99A51TT1 04053252609084

      Documentation

      Certificates of Quality

      Title
      Opticap XL 1 Capsule Polygard CR Media C3NB60862
      Opticap XL 1 Capsule Polygard - CR Media - C9AA65277
      Opticap XL 1 Capsule Polygard -CR Media C0JB88704
      Opticap XL 1 Capsule Polygard -CR Media C4DB07568
      Opticap XL 1 Capsule Polygard-CR Media C7HA12165
      Opticap XL 1 Capsule Polygard-CR Media C7MA52388
      Opticap XL 1 Capsule Polygard-CR Media - C0AB98896
      Opticap XL 1 Capsule Polygard-CR Media - C0BB27791
      Opticap XL 1 Capsule Polygard-CR Media - C7CA81579
      Opticap XL 1 Capsule Polygard-CR Media - C7KA28937
      Show more

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules