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KGSKA03TT3 Autoclavable Millipore Express® SHC Opticap® XL 3 in. 0.5/0.2 µm

Autoclavable Millipore Express® SHC Opticap® XL 3 in. 0.5/0.2 µm MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KGSKA03TT3
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Replacement Information
Description
Catalogue NumberKGSKA03TT3
Trade Name
  • Millipore Express®
DescriptionAutoclavable Millipore Express® SHC Opticap® XL 3 in. 0.5/0.2 µm
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/OutletSanitary Flange/Sanitary Flange
European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Biological Information
MediaMillipore Express® SHC
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.5 / 0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Inlet Pressure (psig)80 psig
Maximum Inlet Temperature25 °C
Non-Fiber ReleasingThis product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
TOC/ConductivityAfter sterilization and a controlled water flush of 5.5 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length3 in. (7.5 cm)
Device Size3 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size3
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Katalogové číslo GTIN
KGSKA03TT3 04053252457524

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Kategorie

Biopharmaceutical Manufacturing > Upstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express > Millipore Express SHC
Biopharmaceutical Manufacturing > Formulation > Sterile Filtration > Sterile Liquid > Millipore Express > Millipore Express SHC
Biopharmaceutical Manufacturing > Harvest > Sterile Filtration > Sterile Liquid > Millipore Express > Millipore Express SHC
Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHC
Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Filtration > Sterile Liquid > Millipore Express > Millipore Express SHC
Biopharmaceutical Manufacturing > Drug Substance > Sterile Filtration > Sterile Liquid > Millipore Express > Millipore Express SHC
Small Molecule Pharmaceuticals > Bulk API > Sterile Filtration > Sterile Liquid > Millipore Express > Millipore Express SHC