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KMP4G2TTT1 Milligard® PES 1.2/0.45 µm, Opticap® T-line 20, TC/TC

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KMP4G2TTT1
1  PE Bag
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Overview

Replacement Information
Description
Catalogue NumberKMP4G2TTT1
Trade Name
  • Milligard® PES
DescriptionMilligard® PES 1.2/0.45 µm, Opticap® T-line 20, TC/TC
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1.5 in.) Sanitary Flange Inlet and 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 Size1.2/0.45 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C2290 mbar (33.3 psi) air with water
Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
Dimensions
Filtration Area1.20 m2 (12.8 ft2)
Inlet Connection Diameter1.5 in.
Outlet Connection Diameter38 mm (1.5 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
Catalogue Number GTIN
KMP4G2TTT1 04065267513560

Documentation

Material Qualification Dossier

TitleVersion
3.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Certificates of Quality

Title
Certificate of Quality KMP4G2TTT1-4DN0362

Technical Info

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

User Guides

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

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