KP15A05HH1

Lifegard^™ 1.0 µm nominal, Opticap^® XL Capsule

inlet connection diam. 9/16 in., Opticap^® XL 5, pore size 1.0 μm, cartridge nominal length 5 in. (12.5 cm)

• Synonym(s): Opticap XL5 Lifegard 1.0 μm 9/16 in. HB/HB
• UNSPSC Code: 23151806
• eCl@ss: 32031610

Properties

• material: borosilicate glass fiber (BGF) ; 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)
• sterility: non-sterile
• Sterilization Compatibility: autoclavable compatible
• product line: Opticap^® XL 5
• feature: hydrophilic
• 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.; 3.5 bar max. differential pressure (50 psid) at 25 °C; 5.5 bar max. inlet pressure (80 psi) at 23 °C; 80 psig max. inlet pressure
• technique(s): prefiltration: suitable
• L: 21.6 cm (8.5 in.) ; 8.5 in.
• W: 4.2 in.
• cartridge nominal length: 5 in. (12.5 cm)
• diam.: 10.7 cm (4.2 in.)
• filtration area: 0.19 m²
• inlet connection diam.: 9/16 in.
• inlet to outlet W: 21.6 cm (8.5 in.)
• outlet connection diam.: 9/16 in.
• impurities: ≤1.0 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.1 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• gravimetric extractables: ≤105 mg/capsule
• matrix: Lifegard^™
• pore size: 1.0 μm nominal pore size; 1.0 μm pore size
• input: sample type liquid
• fitting: inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Specifications

Filter Grade: AP15

Linkage

Replaces: SN1M053A8

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

Analysis Note

Gravimetric Extractables: after a 2 L flush and 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

Lifegard is a trademark of Merck KGaA, Darmstadt, Germany

OPTICAP 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.