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CMP871TS1 Milligard® PES 10" 1.2/0.8 µm Cartridge

CMP871TS1
1  
Purchase on Sigma-Aldrich

Aperçu

Replacement Information
Description
Catalogue NumberCMP871TS1
Trade Name
  • Milligard®
DescriptionMilligard® PES 10" 1.2/0.8 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 / 0.8 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 Area0.53 m² (5.70 ft²)
Device Size10 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polyethersulfone
Seal MaterialSilicone (SI)
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
Référence GTIN
CMP871TS1 04054839617966

Documentation

Material Qualification Dossier

TitreVersion
1.0

Operational Excellence Dossier

Title

Certificats de qualité

Titre
Certificate of Quality CMP871TS1-P020012A14
Certificate of Quality CMP871TS1-P070012B08
Certificate of Quality CMP871TS1-P070023207
Certificate of Quality CMP871TS1-P070033B22

Informations techniques

Titre
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

Manuels d'utilisation

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

Produits & Applications associés

Familles de produits

Milligard® PES Filters

Efficient bioburden and particulate reduction from a broad range of process streams
En savoir plus >>