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KGEPG015FH3 Opticap® XL 150 Millipore Express® SHF Gamma Compatible 0.2 µm 3/4 in. TC-9/16 in. HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KGEPG015FH3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

概述

Replacement Information
Description
Catalogue NumberKGEPG015FH3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 150 Millipore Express® SHF Gamma Compatible 0.2 µm 3/4 in. TC-9/16 in. HB
OverviewSterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 23 °C; 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 ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® SHF
SterilityNon-sterile, Gamma compatible
SterilizationGamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
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 Size0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤1.4 mL/min @ 2.8 bar (40 psig) in water
Bubble Point at 23 °C≥4000 mbar (58 psig) air with water
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 Differential Pressure80 psi (5.5 bar) continuous
100 psi (6.9 bar) intermittent
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 2.0 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 Length3.8 in. (9.7 cm)
Length9.7 cm (3.8 in.)
Diameter5.6 cm (2.2 in.)
Filtration Area220 cm²
Inlet to Outlet Width9.7 cm (3.8 in.)
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Gamma stable polypropylene/Polysulfone
Seal MaterialSilicone (SI)
Support MaterialPolyethylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size3
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Global Trade Item Number
产品目录编号 GTIN
KGEPG015FH3 04053252308277

Documentation

Material Qualification Dossier

标题版本
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

质量证书

标题
OPTICAP XL 150 Capsule Millipore Express SHF membrane C1KB16987
OPTICAP XL 150 Capsule Millipore Express SHF membrane C1NB58182
Opticap XL 150 Capsule Millipore Express SHF Membrane C0SB80406
Opticap XL 150 Capsule Millipore Express SHF Membrane C8JA94186
Opticap XL 150 Capsule Millipore Express SHF Membrane C0DB43284
Opticap XL 150 Capsule Millipore Express SHF Membrane C0KB01495
Opticap XL 150 Capsule Millipore Express SHF Membrane C1NB76658
Opticap XL 150 Capsule Millipore Express SHF Membrane C3BB90988
Opticap XL 150 Capsule Millipore Express SHF Membrane C7DA01352
Opticap XL 150 Capsule Millipore Express SHF Membrane C7NA79692
Show more

技术信息

标题
1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters
Scalable Process Filtration with Opticap® XL 150, 300 and 600 Capsules with Millipore Express® Membranes
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

用户指南

标题
Opticap® XL Capsules and Opticap® XLT Capsules
User Guide - Filters with Millipore Express®Membrane