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KHGEG1STT1 Opticap® Gamma Compatible XLT 10 Millipore Express® SHC 0.5/0.2 µmum TC/TC 1pk w/1.5" TC top

Opticap® Gamma Compatible XLT 10 Millipore Express® SHC 0.5/0.2 µmum TC/TC 1pk w/1.5" TC top MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KHGEG1STT1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKHGEG1STT1
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XLT 10 Millipore Express® SHC 0.5/0.2 µmum TC/TC 1pk w/1.5" TC top
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal; 1 1/2 in. Gauge Port
Housing MaterialPolypropylene (PP)
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.
T-line/Gauge PortT-line with 1-1/2 in. Gauge Port
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMillipore Express® SHC
SterilityNon-sterile, Gamma compatible
Sterilization3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 Size0.5 / 0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
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 PressureForward: 5500 mbar (80 psi) @ 25 °C; 1000 bar (15 psi) @ 80 °C; 6900 mbar (100 psi) @ 25 °C, intermittent. Reverse: 2100 bar (30 psi) @ 25 °C, 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 21 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 Length10 in. (25 cm)
Length37.7 cm (14.8 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.54 m²
Device Size10 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • 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 ≥2 L
Global Trade Item Number
Numer katalogowy GTIN
KHGEG1STT1 04053252486104

Documentation

Emprove Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XLT 10 Capsule Millipore Express SHC membrane C4AB95969
Opticap XLT 10 Capsule Millipore Express SHC Membrane C8MA01663
Opticap XLT 10 Capsule Millipore Express SHC Membrane C0HB78162
Opticap XLT 10 Capsule Millipore Express SHC Membrane C4CB07815
Opticap XLT 10 Capsule Millipore Express SHC Membrane C4DB24210
Opticap XLT 30 Capsule Millipore Express SHC Membrane C0NB22034

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules
Vmax Constant Pressure