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KWSSA10TT1 | Opticap® XL10 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC

KWSSA10TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKWSSA10TT1
      ReplacesKWSS01TC1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatDouble 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 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
      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 Length10 in. (25 cm)
      Length33.5 cm (13.2 in.)
      Diameter14.5 cm (5.7 in.)
      Filtration Area0.69 m²
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size0.5 / 0.2 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 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

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Optciap® XL Capsule Filter with Milligard® Media - C0PA06418
      Opticap XL 10 Capsule Millgard Media - C3EA10157
      Opticap XL 10 Capsule Milligard Media
      Opticap XL 10 Capsule Milligard Media
      Opticap XL 10 Capsule Milligard Media
      Opticap XL 10 Capsule Milligard Media C4SA44357
      Opticap XL 10 Capsule Milligard Media C5AA52870
      Opticap XL 10 Capsule Milligard Media C5MA58429
      Opticap XL 10 Capsule Milligard Media - C2SA14959
      Opticap XL 10 Capsule Milligard Media - C2SA18506
      Opticap XL 10 Capsule Milligard Media - C3AA23802
      Opticap XL 10 Capsule Milligard Media - C3AA37928
      Opticap XL 10 Capsule Milligard Media - C3BA50120
      Opticap XL 10 Capsule Milligard Media - C3CA89701
      Opticap XL 10 Capsule Milligard Media - C3DA92362
      Opticap XL 10 Capsule Milligard Media - C3EA07634
      Opticap XL 10 Capsule Milligard Media - C3JA83410
      Opticap XL 10 Capsule Milligard Media - C3KA93801
      Opticap XL 10 Capsule Milligard Media - C3MA94467
      Opticap XL 10 Capsule Milligard Media - C3PA77425
      Opticap XL 10 Capsule Milligard Media - C4AA97893
      Opticap XL 10 Capsule Milligard Media - C4BA26677
      Opticap XL 10 Capsule Milligard Media - C4CA33664
      Opticap XL 10 Capsule Milligard Media - C4DA44337
      Opticap XL 10 Capsule Milligard Media - C6HA79489
      Opticap XL 10 Capsule Milligard Media C4KA96397
      Opticap XL 10 Capsule Milligard Media C4MA11677
      Opticap XL 10 Capsule Milligard Media C5AA58811
      Opticap XL 10 Capsule Milligard Media C5CA82058
      Opticap XL 10 Capsule Milligard Media C5DA93026
      Opticap XL 10 Capsule Milligard Media C5JA24534
      Opticap XL 10 Capsule Milligard Media C5KA48764
      Opticap XL 10 Capsule Milligard Media C5NA75354
      Opticap XL 10 Capsule Milligard Media C5PA85801
      Opticap XL 10 Capsule Milligard Media C5SA94223
      Opticap XL 10 Capsule Milligard Media C6CA21866
      Opticap XL 10 Capsule Milligard Media C6DA50660
      Opticap XL 10 Capsule Milligard Media C6EA56093
      Opticap XL 10 Capsule Milligard Media C6HA66193
      Opticap XL 10 Capsule Milligard Media C6KA06366
      Opticap XL 10 Capsule Milligard Media C6KA99863
      Opticap XL Capsule Filter with Milligard Media - C0AA83973
      Opticap XL Capsule Filter with Milligard Media - C0CA07968
      Opticap XL Capsule Filter with Milligard Media - C0CA98621
      Opticap XL Capsule Filter with Milligard Media - C0DA20248
      Opticap XL Capsule Filter with Milligard Media - C0EA30387
      Opticap XL Capsule Filter with Milligard Media - C0EA30954
      Opticap XL Capsule Filter with Milligard Media - C0JA55985
      Opticap XL Capsule Filter with Milligard Media - C0JA64614
      Opticap XL Capsule Filter with Milligard Media - C0KA77912
      Opticap XL Capsule Filter with Milligard Media - C0MA85940
      Opticap XL Capsule Filter with Milligard Media - C0PA16754
      Opticap XL Capsule Filter with Milligard Media - C0SA22089
      Opticap XL Capsule Filter with Milligard Media - C1AA34346
      Opticap XL Capsule Filter with Milligard Media - C1CA53698
      Opticap XL Capsule Filter with Milligard Media - C1DA65830
      Opticap XL Capsule Filter with Milligard Media - C1EA77012
      Opticap XL Capsule Filter with Milligard Media - C1JA00008
      Opticap XL Capsule Filter with Milligard Media - C1KA04006
      Opticap XL Capsule Filter with Milligard Media - C1NA36195
      Opticap XL Capsule Filter with Milligard Media - C1SA61275
      Opticap XL Capsule Filter with Milligard Media - C2CA95670
      Opticap XL Capsule Filter with Milligard Media - C2HA28754
      Opticap XL Capsule Filter with Milligard Media - C2HA37137
      Opticap XL Capsule Filter with Milligard Media - C2KA37718
      Opticap XL Capsule Filter with Milligard Media - C2MA64010
      Opticap XL Capsule Filter with Milligard Media - C2MA66816
      Opticap XL Capsule Filter with Milligard Media - C9NN45642
      Opticap XL Capsule Filter with Milligard Media - C9SN68213
      Opticap XL Capsule Filter with Milligard Media - C9SN73066
      Opticap® XL 10 Capsule Milligard® Media - C5HA08877
      Opticap® XL 10 Capsule Milligard® Media C6HA76456
      Opticap® XL 10 Capsule Milligard® Media - C3MA99318
      Opticap® XL 10 Capsule Milligard® Media - C4NA19373
      Opticap® XL Capsule Filter with Miligard® Media - C0HA47654
      Opticap® XL Capsule Filter with Milligard® Media - C0KA71916
      Opticap® XL Capsule Filter with Milligard® Media - C1BA48308
      Opticap® XL Capsule Filter with Milligard® Media - C1HA93355
      Opticap® XL Capsule Filter with Milligard® Media - C1KA01198
      Opticap® XL Capsule Filter with Milligard® Media - C2AA69395

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      Categories

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