KR75A10TT1

Opticap^® XL10 Polygard^®-CR 75 µm 1-1/2 in. TC/TC

• UNSPSC Code: 23151806
• eCl@ss: 32031690

Properties

• Quality Level: 400
• material: polypropylene ; polypropylene housing (PP); polypropylene support; polypropylene vent cap; silicone seal
• sterility: (3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable)
• sterilization compatibility: autoclavable compatible
• parameter: 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 4.8 bar max. differential pressure (70 psid) at 20 °C; 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• L: 33.5 cm (13.2 in.)
• cartridge nominal length: 10 in. (25 cm)
• device size: 10 in.
• diam.: 10.7 cm (4.2 in.) ; 4.2 in. (10.7 cm)
• inlet connection diam.: 1 1/2 in.
• outlet W: 33.5 cm (13.2 in.)
• outlet connection diam.: 1-1/2 in.
• impurities: ≤0.5 EU/mL Aqueous extraction (LAL test)
• matrix: Polygard^®-CR
• pore size: 75.0 μm nominal pore size; 75.0 μm
• fitting: inlet sanitary flange; outlet sanitary flange; 38 mm (1 1/2 in.) sanitary flange drain/vent
• suitability: suitable for endotoxin

Description

General description

A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.

Packaging

Double Easy-Open bag

Analysis Note

The extractables level was equal to or less than 55 mg per capsule after 24 hours in water at controlled room temperature.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L

Other Notes

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.

Legal Information

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany

Disclaimer

All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.