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KMP8G05HH1 Milligard® PES Opticap® XL 5 1.2/0.8 µm Capsule

KMP8G05HH1
1  Double easy open bag
Purchase on Sigma-Aldrich

Overview

Replacement Information
Description
Catalogue NumberKMP8G05HH1
Trade Name
  • Milligard®
DescriptionMilligard® PES Opticap® XL 5 1.2/0.8 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 / 0.8 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Bubble Point at 23 °C≥ 990 mbar (14.3 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 Area0.29 m² (3.1 ft²)
Device Size5 in.
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 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
Catalogue Number GTIN
KMP8G05HH1 04061839737747

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 C0NB37886
Milligard PES Opticap XL 5 Capsule C0BB26839
Milligard PES Opticap XL 5 Capsule C0MB19976
Milligard PES Opticap XL 5 Capsule C1BB05626
Milligard PES Opticap XL 5 Capsule C1CB78976
Milligard PES Opticap XL 5 Capsule C2KB99669
Milligard PES Opticap XL 5 Capsule C2NB16375
Milligard PES Opticap XL 5 Capsule C3EB09886
Milligard PES Opticap XL 5 Capsule C3ab75931

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

User Guides

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

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