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KVSSA10HH1 Opticap® Sterilizing Grade XL10 Multimedia 0.5/0.2/0.22 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVSSA10HH1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Overview

Replacement Information
Description
Catalogue NumberKVSSA10HH1
ReplacesSN2M012A99
Trade Name
  • Opticap®
DescriptionOpticap® Sterilizing Grade XL10 Multimedia 0.5/0.2/0.22 µm 9/16 in. HB/HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Operating Temperature80 °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.
Prefilter MaterialMixed Cellulose Esters (MCE)
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMultimedia Durapore®
SterilitySterile
Sterilization3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.5 / 0.2 / 0.22 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤10.8 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 75 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 Durapore® membrane 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)
Length33.3 cm (13.1 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.56 m²
Device Size10 in.
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Mixed Cellulose Esters (MCE)
  • Polyvinylidene Fluoride (PVDF)
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 ≥5 L
Global Trade Item Number
Catalogue Number GTIN
KVSSA10HH1 04053252560248

Documentation

Opticap® Sterilizing Grade XL10 Multimedia 0.5/0.2/0.22 µm 9/16 in. HB/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Multimedia Durapore Membrane C0HB83646
OPTICAP XL 10 Capsule Multimedia Durapore Membrane C2PB41969Z
Opticap XL 10 Capsule Multimedia Durapore Membrane C8PA36219
Opticap XL 10 Capsule Multimedia Durapore Membrane C0MB10103
Opticap XL 10 Capsule Multimedia Durapore Membrane C0MB49500
Opticap XL 10 Capsule Multimedia Durapore Membrane C7PA56388
Opticap XL 10 Capsule Multimedia Durapore Membrane - C7CA75349
Opticap XL 10 Capsule Multimedia Durapore Membrane - C7DA94272
Opticap XL 10 Capsule Multimedia Durapore Membrane - C7MA35334
Opticap XL 10 Capsule Multimedia Durapore Membrane - C9HA31777
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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