Opticap® XL5 Polygard®-CR 0.5 µm 1-1/2 in. TC/TC

SKU: KRA5A05TT1 Categories: ,

Description

Description
Catalogue Number KRA5A05TT1
Trade Name
  • Opticap®
Description Opticap® XL5 Polygard®-CR 0.5 µm 1-1/2 in. TC/TC

Product Information
Format Single Layer
Device Configuration Capsule
Connections, Inlet/Outlet 38 mm (1-1/2 in.) Sanitary Flange
Housing Material Polypropylene (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 Directive EMD 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 Practices These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Biological Information
Bacterial Endotoxins Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Media Polygard®-CR
Sterilization 3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

Physicochemical Information
Inlet Connection Sanitary Flange
Outlet Connection Sanitary Flange
Gravimetric Extractables The extractables level was equal to or less than 30 mg per capsule after 24 hours in water at controlled room temperature.
Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Inlet Pressure (psig) 80 psig
Maximum Inlet Temperature 25 °C
USP Bacterial Endotoxins A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Dimensions
Cartridge Nominal Length 5 in. (12.5 cm)
Length 21.6 cm (8.5 in.)
Diameter 10.7 cm (4.2 in.)
Inlet to Outlet Width 21.6 cm (8.5 in.)
Device Size 5 in.
Inlet Connection Diameter 1-1/2 in.
Nominal Pore Size 0.5 µm
Outlet Connection Diameter 1-1/2 in.

Materials Information
Chemistry
  • Polypropylene (PP)
Device Material
  • Polypropylene
Seal Material Silicone (SI)
Support Material Polypropylene
Vent Cap Material Polypropylene (PP)

Packaging Information
Material Size 1
Material Package Double Easy-Open bag

Specifications
Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2.5 L

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