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KR99A10TT1 Opticap® XL10 Polygard®-CR 100 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KR99A10TT1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKR99A10TT1
ReplacesKR9901TC1
Trade Name
  • Opticap®
DescriptionOpticap® XL10 Polygard®-CR 100 µm 1-1/2 in. TC/TC
References
Product Information
FormatSingle Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)4.8 bar (70 psid) @ 20 °C
Maximum Inlet Pressure, bar (psi)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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaPolygard®-CR
Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
Physicochemical Information
Pore Size100.0 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Gravimetric ExtractablesThe extractables level was equal to or less than 55 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
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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter1-1/2 in.
Nominal Pore Size100.0 µm
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polypropylene (PP)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolypropylene
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 ≥5 L
Global Trade Item Number
Catalog Number GTIN
KR99A10TT1 04053252456817

Documentation

Opticap® XL10 Polygard®-CR 100 µm 1-1/2 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 10 Capsule Polygard -CR Media C4CB86505
Opticap XL 10 Capsule Polygard -CR Media C0EB73210
Opticap XL 10 Capsule Polygard -CR Media C0HB84333
Opticap XL 10 Capsule Polygard -CR Media C0KB07111
Opticap XL 10 Capsule Polygard -CR Media C7KA59670
Opticap XL 10 Capsule Polygard -CR Media C9JA56918
Opticap XL 10 Capsule Polygard -CR Media C9NA14044
Opticap XL 10 Capsule Polygard -CR Media C3CB97421
Opticap XL 10 Capsule Polygard -CR Media C3HB14942
Opticap XL 10 Capsule Polygard -CR Media C7PA85854
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User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules