KN12A05FF1

Opticap^® XL5 Polygard^® CN

inlet connection diam. 3/4 in., pore size 1.2 μm, cartridge nominal length 5 in. (12.5 cm)

• Synonym(s): Opticap XL5 Polygard-CN 1.2 μm 3/4 in. TC/TC
• UNSPSC Code: 23151806
• eCl@ss: 32031690

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: 5 in. (12.5 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 0.18 m²
• 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: ≤25 mg/capsule
• matrix: Polygard^®-CN
• pore size: 1.2 μm nominal pore size; 1.2 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

Device Configuration: Capsule

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.

Directions for Use

• Organism Retention: Microorganism reduction
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation section of OPTICAP^® XL Capsules and OPTICAP^® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

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 ≥2 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.