KR10A51FF1

Opticap^® XL1 Polygard^® CR

inlet connection diam. 3/4 in., pore size 10.0 μm

• Synonym(s): Opticap^® XL1 Polygard^®-CR 10.0 µm 3/4 in. TC/TC
• UNSPSC Code: 23151806

Properties

• material: polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Quality Level: 400
• reg. compliance: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• manufacturer/tradename: Opticap^®
• 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: 21.6 cm (8.5 in.)
• cartridge nominal length: 1 in. (2.5 cm)
• diam.: 10.7 cm (4.2 in.)
• inlet connection diam.: 3/4 in.
• inlet to outlet W: 21.6 cm (8.5 in.)
• outlet connection diam.: 3/4 in.
• impurities: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤10 mg/capsule
• matrix: Polygard^®-CR
• pore size: 10.0 μm nominal pore size; 10.0 μm pore size
• input: sample type liquid
• fitting: inlet sanitary flange; 19 mm (3/4 in.) inlet/outlet sanitary flange; outlet sanitary flange

Description

General description

Polygard^® CR products are nominally rated filters designed for particle removal applications in liquids and gases. The graded-density depth structure of Polygard^® CR filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.

The KR10A51FF1 Opticap^® XL1Polygard^® CR features a pore size of 10.0 μm. This single layer capsule filter has a sanitary flange inlet/outlet connection measuring 3/4 in. in diameter.

Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design with Polygard^® CR media minimizes hold-up volume and reduces production losses.

Features and Benefits

Format: Single Layer

Packaging

Double Easy-Open bag

Other Notes

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

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

Legal Information

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

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

Disclaimer

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.