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KMP2G05HH1 Milligard® PES Opticap® XL 5 1.2/0.2 µm nominal Capsule

KMP2G05HH1
1  Double easy open bag
Purchase on Sigma-Aldrich

Overview

Replacement Information
Description
Catalogue NumberKMP2G05HH1
Trade Name
  • Milligard®
DescriptionMilligard® PES Opticap® XL 5 1.2/0.2 µm nominal Capsule
References
Product Information
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 / 0.2 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Bubble Point at 23 °C≥ 2700 mbar (39.2 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 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
KMP2G05HH1 04061839737686

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 10 Capsule C2MB08857
Milligard PES Opticap XL 5 Capsule C2BB26154
Milligard PES Opticap XL 5 Capsule - C0BB33968
Milligard PES Opticap XL 5 Capsule C1KB51502
Milligard PES Opticap XL 5 Capsule C3AB79085
Milligard PES Opticap XL 5 Capsule C3EB21323

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