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KHGEG1TTT1H Gamma Compatible High Area Opticap® XLT 10 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KHGEG1TTT1H
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKHGEG1TTT1H
Trade Name
  • Millipore Express®
DescriptionGamma Compatible High Area Opticap® XLT 10 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC
OverviewFamily (FID): Express (FID19B),
Organism Retention: Microorganism
Mode of Action: Filtration (size exclusion)
Application: BioProcessing
Intended Use: Reduction or removal of microorganism/bioburden
Instructions for Use: Please refer installation section of Opticap® XL Capsules and Opticap® XLT Capsules User Guide.
Storage Statement: Store in dry location.
Disposal Statement: Dispose of in accordance with applicable federal, state, and local regulations.
Label statement: Directions for use refer to website.
Label statement: Directions for Use refer Opticap® XL Capsules and Opticap® XLT Capsules User Guide on website (custom product only).
References
Product Information
HS Code8421 22 00
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 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
Quality LevelMQ400
Applications
Key Applications
  • Laboratory Filtration
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
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 Size0.5 / 0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤56.4 mL/min @ 2.75 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
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.
Dimensions
Cartridge Nominal Length10 in. (25 cm)
Length37.6 cm (14.8 in.)
Diameter10.7 in. (4.2 cm)
Filtration Area10000 cm2
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size10 in.
Outlet Connection Diameter1.5 in.
Materials Information
Chemistry
  • Hydrophilic 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
Katalogové číslo GTIN
KHGEG1TTT1H 04054839167850

Documentation

Material Qualification Dossier

TitleVersion
1.0

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XLT 10 Capsule Millipore Express SHC High area membrane C3MB59358
Opticap XL 10 Capsule Millipore Express SHC High Area Membrane C0PB26227
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane C0JB89740
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane C3HB20003
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane C9AA44665
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane - C8BA06644
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane - C8DA35233
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane - C8JA78864
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane - C9HA44480
Opticap XLT 10 Capsule Millipore Express SHC High Area Membrane C1HB80684
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Technical Info

Title
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
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Data Sheet

Title
Millipore Express®SHC Hydrophilic Filters

User Guides

Title
User Guide - Filters with Millipore Express®Membrane

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Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHC