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KW03A04TT3 | Opticap® XL4 Milligard® 0.2 µm 1-1/2 in. TC/TC

KW03A04TT3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKW03A04TT3
      ReplacesKW0304TC1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL4 Milligard® 0.2 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatSingle Layer
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Filter GradeStandard Milligard® Media
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMilligard®
      Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
      Physicochemical Information
      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
      Non-Fiber ReleasingThis product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      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 Length4 in. (10 cm)
      Length19.6 cm (7.7 in.)
      Diameter12.5 cm (4.9 in.)
      Filtration Area0.2 m²
      Inlet to Outlet Width19.6 cm (7.7 in.)
      Device Size4 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size0.2 µm
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      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

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      KW03A04TT3 - C3AA39939
      Opitcap XL 4 Capsule Milligard Media - C4DA41443
      Opitcap XL 4 Capsule Milligard Media - C4MA07178
      Opticap XL 4 Capsule Milligard Media
      Opticap XL 4 Capsule Milligard Media
      Opticap XL 4 Capsule Milligard Media C5BA65412
      Opticap XL 4 Capsule Milligard Media - C2PA05783
      Opticap XL 4 Capsule Milligard Media - C2PA90378
      Opticap XL 4 Capsule Milligard Media - C2SA14941
      Opticap XL 4 Capsule Milligard Media - C3BA48596
      Opticap XL 4 Capsule Milligard Media - C3DA02759
      Opticap XL 4 Capsule Milligard Media - C3DA05147
      Opticap XL 4 Capsule Milligard Media - C3EA11895
      Opticap XL 4 Capsule Milligard Media - C3HA70663
      Opticap XL 4 Capsule Milligard Media - C3JA81065
      Opticap XL 4 Capsule Milligard Media - C3JA83406
      Opticap XL 4 Capsule Milligard Media - C3KA91772
      Opticap XL 4 Capsule Milligard Media - C3MA15794
      Opticap XL 4 Capsule Milligard Media - C3MA24434
      Opticap XL 4 Capsule Milligard Media - C3PA67203
      Opticap XL 4 Capsule Milligard Media - C3SA78703
      Opticap XL 4 Capsule Milligard Media - C3SA83637
      Opticap XL 4 Capsule Milligard Media - C4AA94141
      Opticap XL 4 Capsule Milligard Media - C4CA32079
      Opticap XL 4 Capsule Milligard Media - C6AA09218
      Opticap XL 4 Capsule Milligard Media - C6DA50743
      Opticap XL 4 Capsule Milligard Media - C6JA89970
      Opticap XL 4 Capsule Milligard Media C4JA88054
      Opticap XL 4 Capsule Milligard Media C4NA24537
      Opticap XL 4 Capsule Milligard Media C4NA25541
      Opticap XL 4 Capsule Milligard Media C4NA29370
      Opticap XL 4 Capsule Milligard Media C4PA33523
      Opticap XL 4 Capsule Milligard Media C4SA40095
      Opticap XL 4 Capsule Milligard Media C4SA48211
      Opticap XL 4 Capsule Milligard Media C5AA56404
      Opticap XL 4 Capsule Milligard Media C5CA71981
      Opticap XL 4 Capsule Milligard Media C5DA93350
      Opticap XL 4 Capsule Milligard Media C5JA22153
      Opticap XL 4 Capsule Milligard Media C5JA35218
      Opticap XL 4 Capsule Milligard Media C5KA44203
      Opticap XL 4 Capsule Milligard Media C5MA54812
      Opticap XL 4 Capsule Milligard Media C5NA62531
      Opticap XL 4 Capsule Milligard Media C5SA97194
      Opticap XL 4 Capsule Milligard Media C6EA65360
      Opticap XL 4 Capsule Milligard Media C6HA81271
      Opticap XL 4 Capsule Milligard Media C6KA99446
      Opticap XL 4 Capsule Milligard Media C6NA21423
      Opticap XL 4 Capsule Milligard Media C6PA34860
      Opticap XL 4 Milligard Media - C3CA89881
      Opticap XL Capsule Filter with Milligard Media - C0BA95475
      Opticap XL Capsule Filter with Milligard Media - C0CA13997
      Opticap XL Capsule Filter with Milligard Media - C0JA59299
      Opticap XL Capsule Filter with Milligard Media - C0NA91211
      Opticap XL Capsule Filter with Milligard Media - C0SA16795
      Opticap XL Capsule Filter with Milligard Media - C1BA34370
      Opticap XL Capsule Filter with Milligard Media - C1BA49444
      Opticap XL Capsule Filter with Milligard Media - C1EA76650
      Opticap XL Capsule Filter with Milligard Media - C1KA01193
      Opticap XL Capsule Filter with Milligard Media - C1KA09663
      Opticap XL Capsule Filter with Milligard Media - C1KA17410
      Opticap XL Capsule Filter with Milligard Media - C1MA22365
      Opticap XL Capsule Filter with Milligard Media - C1PA49217
      Opticap XL Capsule Filter with Milligard Media - C1SA60897
      Opticap XL Capsule Filter with Milligard Media - C2DA96497
      Opticap XL Capsule Filter with Milligard Media - C2EA15285
      Opticap XL Capsule Filter with Milligard Media - C2HA26824
      Opticap XL Capsule Filter with Milligard Media - C2JA37746
      Opticap XL Capsule Filter with Milligard Media - C2KA44998
      Opticap XL Capsule Filter with Milligard Media - C2KA53004
      Opticap XL Capsule Filter with Milligard Media - C2MA66885
      Opticap XL Capsule Filter with Milligard Media - C2NA68211
      Opticap XL Capsule Filter with Milligard Media - C9SN68219
      Opticap® XL 4 Capsule Milligard® Media - C5BA61322
      Opticap® XL 4 capsule Milligard® Media - C4BA97179
      Opticap® XL Capsule Filter with Milligard Media - C0EA38207
      Opticap® XL Capsule Filter with Milligard® Media - C0KA61966
      Opticap® XL Capsule Filter with Milligard® Media - C0PA07750
      Opticap® XL Capsule Filter with Milligard® Media - C1PA38638
      Opticap® XL Capsule Filter with Milligard® Media - C2AA63225
      Opticap® XL Capsule Filter with Milligard® Media - C2AA78845

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      Categories

      Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard