Millipore Sigma Vibrant Logo
Attention: We have moved. Merck Millipore products are no longer available for purchase on MerckMillipore.com.Learn More

KGEPS05TH1 Opticap® XL 5 Millipore Express® SHF Sterile 0.2 µm 1-1/2 in. TC-9/16 in. HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KGEPS05TH1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Overview

Replacement Information
Description
Catalogue NumberKGEPS05TH1
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 5 Millipore Express® SHF Sterile 0.2 µm 1-1/2 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/Outlet38 mm (1-1/2 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 @ 25 °C; 5.5 bar (80 psi) @ 25 °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
SterilitySterile
Sterilization3 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≤17.4 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 6.0 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 Length5 in. (12.5 cm)
Length21.6 cm (8.5 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.31 m²
Inlet to Outlet Width21.6 cm (8.5 in.)
Device Size5 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Gamma stable polypropylene/Polysulfone
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 ≥1 L
Global Trade Item Number
Catalogue Number GTIN
KGEPS05TH1 04053252256684

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
Opticap XL 5 Capsule Millipore Express SHF Membrane C1MB69926
Opticap XL 5 Capsule Millipore Express SHF Membrane C2PB47260
Opticap XL 5 Capsule Millipore Express SHF Membrane C7SA08847
Opticap XL 5 Capsule Millipore Express SHF Membrane - C7HA22672
Opticap XL 5 Capsule Millipore Express SHF Membrane C1HB09992
Opticap XL 5 Capsule Millipore Express SHF Membrane C2BB22941
Opticap XL 5 Capsule Millipore Express SHF Membrane C2HB75473
Opticap XL 5 Capsule Millipore Express SHF Membrane C2HB89022
Opticap XL 5 Capsule Millipore Express SHF Membrane C3DB99447
Opticap XL 5 Capsule Millipore Express SHF Membrane C3PB66641
Show more

Technical Info

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

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules