CDUFBC001

Biopak^® C Clinical Cartridge

Removes bacteria and bacterial by-products from water. For use with AFS^® and Milli-Q^® CLX systems.

• UNSPSC Code: 41104212
• eCl@ss: 33050190
• NACRES: NA.21

Properties

• Quality Level: 300
• sterility: 0.22 μm filtered
• feature: better assay reliability, Reduces the need for frequent analyzer calibration
• composition: (polysulfone hollow fibers)
• packaging: pkg of 1 unit
• manufacturer/tradename: BioPak^®
• parameter: ≥1 bar pressure (3 bar); 0.5 mL/min air diffusion at 2 bar; 1.5 L/min flow rate at 1 bar and 20 °C; 5 °C temp. range (35 °C)
• volume: 100 L ; 100000 mL
• total organic carbon (TOC) residue: <500 ppb (after 5 L Rinsing)
• pore size: 0.22 μm pore size
• fitting: 1/4 in. inlet connection (Gaz (Straight) Luer Slip F); 8 mm outlet connection (PTFE)
• compatibility: for use with AFS^®; for use with Milli-Q^® CLX
• shipped in: ambient

Description

General description

The Biopak^® C unit is an easy-to-install, disposable ultrafiltration cartridge that provides a final, in-line purification step for immunoassay and clinical chemistry analyzers.
The cartridge efficiently removes bacteria and bacterial by-products, such as alkaline phosphatase (ALP), from analyzer feed water, which is used to dilute reagents, make blanks, and rinse tubing and probes. This results in a more stable baseline and better assay reliability.
The Biopak^® C ultrafiltration cartridge is composed of polysulfone hollow fibers. This membrane optimizes the rejection of bacterial ALP and bacteria while maintaining a high flow rate.

Application

When fed with high-quality pure water, the Biopak^® C ultrafiltration cartridge efficiently removes bacterial by-products such as ALP, to provide optimum-quality water for use in ALP-sensitive immunoassays.

Features and Benefits

• Produces ALP-free water (< 1 μUnits/μL).
• Ensures bacteria levels below 10 cfu/mL (typically < 1 cfu/mL).
• Designed to remove endotoxins, and to perform a pyrogen log reduction value superior or equal to 4, for pyrogen feed concentration between 1000 and 10 000 EU/mL, and a nuclease reduction from 1 μg/mL to less than 0.01 ng/mL at 1 bar feed water pressure.
• Supports stable assay baselines, resulting in better assay reliability.
• Reduces the need for frequent analyzer calibration.
• Eliminates the need for frequent analyzer decontamination that results in costly downtime.
• Includes: Self-adhesive label.
• Replaced every 6 months for optimal results.

Components

Polysulfone hollow fibers for ALP and bacteria removal

Other Notes

Directions for Use

• Organism Retention: Bacteria and pyrogens
• Mode of Action: Ultrafiltration
• Application: Cell culture media, molecular biology
• Intended Use: Bioburden reduction
• Instructions for Use: This item provides water filtered through ultrafiltration hollow fibers. Refer to insert, section "replacement" in the product package.
• Storage Statement: Store in a dry location.
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Legal Information

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

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

Milli-Q is a registered trademark of Merck KGaA, Darmstadt, Germany