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KW19A04HH3 Opticap® XL4 Milligard® 1.2 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KW19A04HH3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKW19A04HH3
ReplacesKW1904HB1
Trade Name
  • Opticap®
DescriptionOpticap® XL4 Milligard® 1.2 µm 9/16 in. HB/HB
References
Product Information
FormatSingle Layer
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
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.
Quality LevelMQ400
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
Pore Size1.2 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
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 Diameter9/16 in.
Nominal Pore Size1.2 µm
Outlet Connection Diameter9/16 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
Global Trade Item Number
Catalog Number GTIN
KW19A04HH3 04053252461422

Documentation

Opticap® XL4 Milligard® 1.2 µm 9/16 in. HB/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 4 Capsule Milligaed Media C7HA28107
Opticap XL 4 Capsule Milligard Media C7CA86154
Opticap XL 4 Capsule Milligard Media C7DA01323
Opticap XL 4 Capsule Milligard Media C8DA42377
Opticap XL 4 Capsule Milligard Media C0AB90022
Opticap XL 4 Capsule Milligard Media C0MB15217
Opticap XL 4 Capsule Milligard Media C0NB26489
Opticap XL 4 Capsule Milligard Media C1AB83327
Opticap XL 4 Capsule Milligard Media C2MB16413
Opticap XL 4 Capsule Milligard Media C3NB64413
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules

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Categories

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