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KR99A05FF1 Opticap® XL5 Polygard®-CR 100 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KR99A05FF1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKR99A05FF1
Trade Name
  • Opticap®
DescriptionOpticap® XL5 Polygard®-CR 100 µm 3/4 in. TC/TC
References
Product Information
FormatSingle Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 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 30 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 Length5 in. (12.5 cm)
Length21.6 cm (8.5 in.)
Diameter10.7 cm (4.2 in.)
Inlet to Outlet Width21.6 cm (8.5 in.)
Device Size5 in.
Inlet Connection Diameter3/4 in.
Nominal Pore Size100.0 µm
Outlet Connection Diameter3/4 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 ≥2.5 L
Global Trade Item Number
Catalog Number GTIN
KR99A05FF1 04053252446313

Documentation

Opticap® XL5 Polygard®-CR 100 µm 3/4 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 5 Capsule Polygard - CR Media - C0EB62356
Opticap XL 5 Capsule Polygard -CR Media C0MB81660
Opticap XL 5 Capsule Polygard -CR Media C2CB52398
Opticap XL 5 Capsule Polygard -CR Media C8DA60593
Opticap XL 5 Capsule Polygard CR Media C8NA38075
Opticap XL 5 Capsule Polygard CR Media C0NB37103
Opticap XL 5 Capsule Polygard-CR Media C1AB83106
Opticap XL 5 Capsule Polygard-CR Media C9NA07896
Opticap XL 5 Capsule Polygard-CR Media - C7PA79749
Opticap XL 5 Capsule Polygard-CR Media C1MB15200
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User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules