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KMP8G3TTT1 Milligard® PES 1.2/0.8 µm, Opticap® T-line 30, TC/TC

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KMP8G3TTT1
1  PE Bag
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Overview

Replacement Information
Description
Catalogue NumberKMP8G3TTT1
Trade Name
  • Milligard® PES
DescriptionMilligard® PES 1.2/0.8 µm, Opticap® T-line 30, 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 Size1.2/0.8 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C990 mbar (14.3 psi) air with water
Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
Dimensions
Filtration Area1.73 m2 (18.6 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
Catalog Number GTIN
KMP8G3TTT1 04065267513645

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 KMP8G3TTT1-2KJ1927
Certificate of Quality KMP8G3TTT1-2KP0101
Certificate of Quality KMP8G3TTT1-3B31035
Certificate of Quality KMP8G3TTT1-3JD1167
Certificate of Quality KMP8G3TTT1-3JG0739
Certificate of Quality KMP8G3TTT1-3JG0739
Certificate of Quality KMP8G3TTT1-3NG0170
Certificate of Quality KMP8G3TTT1-4GS1884

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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