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KMP4G05TT1 Milligard® PES Opticap® XL 5 1.2/0.45 µm Capsule

KMP4G05TT1
1  Double easy open bag
Purchase on Sigma-Aldrich

Áttekintés

Replacement Information
Description
Catalogue NumberKMP4G05TT1
Trade Name
  • Milligard®
DescriptionMilligard® PES Opticap® XL 5 1.2/0.45 µm Capsule
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psi) at 4-25°C
1.7 bar (25 psi) at 80°C
Reverse: 1.4 bar (20 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
SterilizationGamma irradiation up to 40 kGy and 3 wet autoclave cycles of 60 minutes at 123°C
Physicochemical Information
Pore Size1.2 / 0.45 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥ 2290 mbar (33.3 psi) air with water
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 based on information provided by raw material suppliers.
Non-Fiber ReleasingDevices tested and meet requirements of USP <788> for large volume parenterals.
Dimensions
Length21.6 cm (8.5 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.30 m² (3.2 ft²)
Device Size5 in.
Inlet Connection Diameter1.5 in.
Outlet Connection Diameter1.5 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polyethersulfone
Support MaterialPolyester
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Material PackageDouble easy open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Katalógusszám GTIN
KMP4G05TT1 04061839737693

Documentation

Material Qualification Dossier

TitleVersion
3.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
Milligard PES Opticap XL 5 Capsule C2JB86315
Milligard PES Opticap XL 5 Capsule C4EB39983
Milligard PES Opticap XL 5 Capsule C4PB08575
Milligard PES Opticap XL 5 Capsule C9NA16417
Milligard PES Opticap XL 5 Capsule C1HB19508
Milligard PES Opticap XL 5 Capsule C2JB84395
Milligard PES Opticap XL 5 Capsule C2MB08861
Milligard PES Opticap XL 5 Capsule C2SB57132
Milligard PES Opticap XL 5 Capsule C3BB93592
Milligard PES Opticap XL 5 Capsule C3EB09335
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Technical Info

Title
Bioburden Reduction and Particulate Retention Using Milligard®PES Filters
How Membrane Prefilters Enhance Bioprocessing Efficiency
Processing mAb streams - How a bioburden reduction filter can improve process efficiency

Data Sheet

Title
Millipore Express® Family Guide

User Guides

Title
User Guide -Opticap® Small Scale 300, Opticap® XL and XLT , and T-line Capsules
User Guide - Filters with Milligard®PES Membrane

Kapcsolódó termékek és alkalmazások

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