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KEGBG003FF3 Gamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange

Gamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KEGBG003FF3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKEGBG003FF3
Trade Name
  • Opticap®
DescriptionGamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange
References
Product Information
HS Code8421 39 90
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 4.2 bar (60 psid) @ 25 °C; Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)4.1 bar (60 psi) @ 23 °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
Key Applications
  • Small scale single-use applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® SPG
SterilityGamma
SterilizationGamma compatible to 45 kGy; 3 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.
WettabilityHydrophobic
Physicochemical Information
Pore Size0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥1210 mbar (17.5 psig) air with 70/30 % IPA/water
Gravimetric ExtractablesThe extractables level was equal to or less than 3 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
HydroCorr≤0.16 mL/min @ 2.6 bar (38 psig)
Maximum Inlet Pressure (psig)60 psig
Maximum Differential Pressure60 psi (4.1 bar) continuous
Maximum Inlet Temperature25 °C
Non-Fiber ReleasingThis product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
TOC/ConductivityAfter gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Length11.9 cm (4.7 in.)
Diameter5.6 cm (2.2 in.)
Filtration Area0.048 m²
Inlet to Outlet Width11.9 cm (4.7 in.)
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Gamma stable polypropylene/Polysulfone
Seal MaterialSilicone (SI)
Support MaterialPolyethylene
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
Global Trade Item Number
Katalogové číslo GTIN
KEGBG003FF3 04053252970405

Documentation

Certificates of Quality

Title
OPTICAP XL 300 Capsule Millipore Express SPG Membrane C3SB90743
Opticap XL 300 Ca[sule Millipore Express SPG Membrane C2AB08586
Opticap XL 300 Capsule MIllipore Express SPG Membrane C0CB38544
Opticap XL 300 Capsule MIllipore Express SPG Membrane C0DB48095
Opticap XL 300 Capsule Millipore Excpress SPG Membrane C8NA43773
Opticap XL 300 Capsule Millipore Express SPG Membrane C2SB52510
Opticap XL 300 Capsule Millipore Express SPG Membrane
Opticap XL 300 Capsule Millipore Express SPG Membrane
Opticap XL 300 Capsule Millipore Express SPG Membrane C7KA35664
Opticap XL 300 Capsule Millipore Express SPG Membrane C8MA24344
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Performance of Gamma Stable Opticap®XL 50 Capsule Filter with Millipore Express®SPG Membrane vs. Competitor’s 50 mm Gamma Stable Hydrophobic PVDF Membrane Filter for a Typical Fed Batch Cell Culture Process
Vent Filter Sizing for Mobius®Single-use Mixing Solution

Data Sheet

Title
Gamma Stable Opticap®XL Capsule Filters with Millipore Express®SPG Hydrophobic Membrane