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CMP272TS1 Milligard® PES 20" 1.2/0.2 µm nominal Cartridge

CMP272TS1
1  
Purchase on Sigma-Aldrich

概述

Replacement Information
Description
Catalogue NumberCMP272TS1
Trade Name
  • Milligard®
DescriptionMilligard® PES 20" 1.2/0.2 µm nominal Cartridge
References
Product Information
FormatDouble Layer
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 + 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 / 0.2 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 Length20 in. (50 cm)
Length635 mm (25 in.)
Diameter69 mm (2.71 in.)
Filtration Area1.2 m²(13 ft² )
Device Size20 in.
Nominal Pore Size1.2/0.2 µm
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
产品目录编号 GTIN
CMP272TS1 04054839617973

Documentation

Material Qualification Dossier

标题版本
1.0

Operational Excellence Dossier

Title

质量证书

标题
Certificate of Quality CMP272TS1-P070013426
Certificate of Quality CMP272TS1-P070013516
Certificate of Quality CMP272TS1-P070013610
Certificate of Quality CMP272TS1-P070022A18
Certificate of Quality CMP272TS1-P070023808
Certificate of Quality CMP272TS1-P070044304
Certificate of Quality CMP272TS1-P070044425
Certificate of Quality CMP272TS1-P070084125

技术信息

标题
How Membrane Prefilters Enhance Bioprocessing Efficiency
Processing mAb streams - How a bioburden reduction filter can improve process efficiency

用户指南

标题
User Guide -Opticap® Small Scale 300, Opticap® XL and XLT , and T-line Capsules
User Guide - Filters with Milligard®PES Membrane

相关产品和应用

产品族

Milligard® PES Filters

Efficient bioburden and particulate reduction from a broad range of process streams
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