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KWSCA05FF1 Opticap® XL5 Milligard® 1.2/0.5 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KWSCA05FF1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

概述

Replacement Information
Description
Catalogue NumberKWSCA05FF1
Trade Name
  • Opticap®
DescriptionOpticap® XL5 Milligard® 1.2/0.5 µm 3/4 in. TC/TC
References
Product Information
FormatDouble Layer
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
Filter GradeStandard Milligard® Media
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
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
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMilligard®
Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
Physicochemical Information
Pore Size1.2 / 0.5 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
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 media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length5 in. (12.5 cm)
Length21.6 cm (8.5 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.28 m²
Inlet to Outlet Width21.6 cm (8.5 in.)
Device Size5 in.
Inlet Connection Diameter3/4 in.
Nominal Pore Size1.2 / 0.5 µm
Outlet Connection Diameter3/4 in.
Materials Information
Chemistry
  • Mixed Cellulose Esters (MCE)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolyester
Vent Cap MaterialPolypropylene (PP)
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
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
Global Trade Item Number
产品目录编号 GTIN
KWSCA05FF1 04053252652783

Documentation

Opticap® XL5 Milligard® 1.2/0.5 µm 3/4 in. TC/TC MSDS

职位

物料安全数据表 (MSDS) 

质量证书

标题
Opticap XL 5 Capsule Milligard Media C9DA29174
Opticap XL 5 Capsule Milligard Media C3HB17160
Opticap XL 5 Capsule Milligard Media C1KB51493
Opticap XL 5 Capsule Milligard Media C2EB52766
Opticap XL 5 Capsule Milligard Media C3HB30158
Opticap XL 5 Capsule Milligard Media C4CB17658
Opticap XL 5 Capsule Milligard Media C7NA79743

技术信息

标题
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

用户指南

标题
Opticap® XL Capsules and Opticap® XLT Capsules

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种类

Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard