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KR01A05FF1 Opticap® XL5 Polygard®-CR 1.0 µm 3/4 in. TC/TC

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KR01A05FF1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKR01A05FF1
Trade Name
  • Opticap®
DescriptionOpticap® XL5 Polygard®-CR 1.0 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 Size1.0 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 Size1.0 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
Catalogue Number GTIN
KR01A05FF1 04053252456848

Documentation

Certificates of Quality

Title
Opticap XL 5 Capsule Polygard -CR Media C8SA65341
Opticap XL 5 Capsule Polygard -CR Media C7HA84487
Opticap XL 5 Capsule Polygard-CR Media - C7SA05069
Opticap XL 5 Capsule Polygard-CR Media - C8BA24523
Opticap XL 5 Capsule Polygard-CR Media C1EB07693
Opticap XL 5 Capsule Polygard-CR Media C2MB08881
Opticap XL 5 Capsule Polygard-CR Media C3PB81260
Opticap XL 5 Capsule Polygard-CR Media C8HA82834
Opticap XL 5 Capsule Polygard-CR Media C8KA13426
Opticap XL 5 Capsule Polygard-CR Media C9DA22454

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules

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Categories

Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Depth Filter based > Polygard CR
Biopharmaceutical Manufacturing > Downstream Processing > Clarification > Clarisolve Depth Filters > Polygard Filters > Polygard CR