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KMP2G10HH1 Milligard® PES Opticap® XL 10 1.2/0.2 µm nominal Capsule

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KMP2G10HH1
1  Double easy open bag
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Overview

Replacement Information
Description
Catalogue NumberKMP2G10HH1
Trade Name
  • Milligard®
DescriptionMilligard® PES Opticap® XL 10 1.2/0.2 µm nominal 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 / 0.2 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
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.60 m² (6.4 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
KMP2G10HH1 04061839737426

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 C0PB52919
Milligard PES Opticap XL 10 Capsule C2PB47293
Milligard PES Opticap XL 10 Capsule C0JB92496
Milligard PES Opticap XL 10 Capsule - C0CB49489
Milligard PES Opticap XL 10 Capsule C1KB51436
Milligard PES Opticap XL 10 Capsule C2BB26155
Milligard PES Opticap XL 10 Capsule C3DB05124
Milligard PES Opticap XL 10 Capsule C3HB31487
Milligard PES Opticap XL 10 Capsule C3NB66840
Milligard PES Opticap XL 10 Capsule C4BB07563
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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

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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