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KMP8G05TH1 Milligard® PES Opticap® XL 5 1.2/0.8 µm Capsule

KMP8G05TH1
1  Double easy open bag
Purchase on Sigma-Aldrich

Panoramica

Replacement Information
Description
Catalogue NumberKMP8G05TH1
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 ConnectionSanitary Flange
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 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
Numero di catalogo GTIN
KMP8G05TH1 04061839737730

Documentation

Material Qualification Dossier

TitoloVersione
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificati di Qualità

Titolo
Milligard PES Opticap XL 5 Capsule - C0BB26840
Milligard PES Opticap XL 5 Capsule C3NB63788

Informazioni tecniche

Titolo
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

Manuali d'uso

Titolo
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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