Gas Filtration

Gamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange 요약정보 및 구매

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Description
Catalogue NumberKEGBG003FF3
Trade Name
  • Opticap®
DescriptionGamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange
Product Information
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)
Packaging Information
Material Size3
Material PackageDouble Easy-Open bag

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