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KMP2G3STH1 Milligard® PES 1.2/0.2 µm nominal, Opticap® T-line 30, TC/HB with gauge port

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KMP2G3STH1
1  PE Bag
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Descripción

Replacement Information
Description
Catalogue NumberKMP2G3STH1
Trade Name
  • Milligard® PES
DescriptionMilligard® PES 1.2/0.2 µm nominal, Opticap® T-line 30, TC/HB with gauge port
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1.5 in.) Sanitary Flange Inlet and 19 mm (6/8 in.) Hose Barb Outlet.
Maximum Differential Pressure, bar (psid)Forward: 4.5 bar (65 psid) at 4-25°C; 1.7 bar (25 psid) at 80°C, Reverse: 1.4 bar (20 psid) at 25°C
Maximum Inlet Pressure, bar (psi)4.5 bar (65 psi) at 25 °C
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains <0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01.
MediaMilligard® PES
SterilityAutoclavable/Gamma Compatible
Sterilization3 autoclave cycles of 60 min @ 123 °C; gamma exposure up to 40 kGy
WettabilityHydrophilic
Physicochemical Information
Pore Size1.2/0.2 µm nominal
Inlet ConnectionSanitary Flange
Outlet ConnectionHose Barb
Bubble Point at 23 °C2700 mbar (39.2 psi) air with water
Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
Dimensions
Filtration Area1.80 m2 (19.4 ft2)
Inlet Connection Diameter1.5 in.
Outlet Connection Diameter19 mm (6/8 in)
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Hydrophilic polyethersulfone
Support MaterialPolyester
Vent Cap MaterialSilicone
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Material PackagePE Bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Número de referencia GTIN
KMP2G3STH1 04065267513799

Documentation

Material Qualification Dossier

CargoVersión
4.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Licencias necesarias e Información técnica

Cargo
How Membrane Prefilters Enhance Bioprocessing Efficiency
Processing mAb streams - How a bioburden reduction filter can improve process efficiency

Manuales del usuario

Cargo
User Guide -Opticap® Small Scale 300, Opticap® XL and XLT , and T-line Capsules

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Efficient bioburden and particulate reduction from a broad range of process streams
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