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CMP471TS1 Milligard® PES 10" 1.2/0.45 µm Cartridge

CMP471TS1
1  
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Replacement Information
Description
Catalogue NumberCMP471TS1
Trade Name
  • Milligard®
DescriptionMilligard® PES 10" 1.2/0.45 µm Cartridge
References
Product Information
HS Code8421 29 90
Device ConfigurationCartridge
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 5.52 bar (80 psid) at 4-25°C
Reverse: 1.38 bar (20 psid) at 25°C
Cartridge CodeCode 7 (2-226) O-ring and spear
Good Manufacturing PracticesThe product is manufactured in a facility which adheres to Good Manufacturing Practices. The manufacturing facility’s Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Standard.
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
SterilizationAutoclave wet 25x, 60 minute cycles at 128°C. In-line steam (wet): 10 forward cycles, 30 min.,
135 °C at ≤0.34 bar (5 psid) and 5 reverse cycles,
30 min., 135 °C at ≤0.07 bar (<1 psid)*.
*Devices were validated using steam at full differential pressure starting at 31 psid to a final differential pressure of 1 psid, resulting in a calculated average of 4 psid in forward and reverse directions.
Physicochemical Information
Pore Size1.2 / 0.45 µm
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Non-Fiber ReleasingThis product was manufactured with materials that meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Dimensions
Cartridge Nominal Length10 in. (25 cm)
Length317.5 mm (12.5 in.)
Diameter69 mm (2.71 in.)
Filtration Area0.60 m² (6.5 ft²)
Device Size10 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polyethersulfone
Support MaterialPolypropylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Katalogové číslo GTIN
CMP471TS1 04054839617959

Documentation

Material Qualification Dossier

TitleVersion
1.0

Operational Excellence Dossier

Title

Certificates of Quality

Title
Certificate of Quality CMP471TS1-070022B08
Certificate of Quality CMP471TS1-P070012A15
Certificate of Quality CMP471TS1-P070013207
Certificate of Quality CMP471TS1-P070013425
Certificate of Quality CMP471TS1-P070013828
Certificate of Quality CMP471TS1-P070013828
Certificate of Quality CMP471TS1-P070013B13
Certificate of Quality CMP471TS1-P070013B13.
Certificate of Quality CMP471TS1-P070014321
Certificate of Quality CMP471TS1-P070022B08
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Technical Info

Title
How Membrane Prefilters Enhance Bioprocessing Efficiency
Processing mAb streams - How a bioburden reduction filter can improve process efficiency
Steam-in-Place Sterilization of Filtration Trains containing Milligard®PES Prefilters

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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