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K010A51HH1 Opticap® XL1 Clarigard® 1.0 µm 9/16 in. HB/HB

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K010A51HH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberK010A51HH1
Trade Name
  • Opticap®
DescriptionOpticap® XL1 Clarigard® 1.0 µm 9/16 in. HB/HB
References
Product Information
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) @ 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 ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaClarigard®
Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Physicochemical Information
Pore Size1.0 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
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 0.25 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 Size1.0 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
Catalog Number GTIN
K010A51HH1 04053252347726

Documentation

Certificates of Quality

Title
Opticap XL 1 Capsule Clarigard Media C3NB55618
Opticap XL 1 Capsule Clarigard Media C8BA20312
Opticap XL 1 Capsule Clarigard Media C0CB49408
Opticap XL 1 Capsule Clarigard Media C0NB19547
Opticap XL 1 Capsule Clarigard Media C7SA08904
Opticap XL 1 Capsule Clarigard Media C9DA07456
Opticap XL 1 Capsule Clarigard Media - C0AB90107
Opticap XL 1 Capsule Clarigard Media - C0BB25336
Opticap XL 1 Capsule Clarigard Media - C7MA40548
Opticap XL 1 Capsule Clarigard Media - C7SA05056
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User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules