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KMP8G10HH1 Milligard® PES Opticap® XL 10 1.2/0.8 µm Capsule

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KMP8G10HH1
1  Double easy open bag
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Overview

Replacement Information
Description
Catalogue NumberKMP8G10HH1
Trade Name
  • Milligard®
DescriptionMilligard® PES Opticap® XL 10 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
European Pressure Equipment DirectiveEMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 2014/68/EU of 15 May 2014. This product has been classified under Article 4 § 3 of the Directive 2014/68/EU. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 4 § 3 of the Directive 2014/68/EU, this product does not bear the CE mark.
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
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.57 m² (6.1 ft²)
Device Size10 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
Catalog Number GTIN
KMP8G10HH1 04061839737488

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 C0NB41575
Milligard PES Opticap XL 10 Capsule C4PB10142
Milligard PES Opticap XL10 Capsule C2PB44613

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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